1. ENGLEWOOD, Colo., March 3, 2021 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced that management will present at the virtual H.C. Wainwright Global Life Sciences Conference scheduled Tuesday, March 9, 2021 through Wednesday, March 10, 2021.

    The video webcast presentation will be available for viewing on-demand beginning Tuesday, March 9, 2021 at 7:00 am (EST) for those registered for the event and will be accessible on the Presentations & Media page in the Investors section of the Company's website (https://ampiopharma.com/investors/presentations-media/). The webcast replay will be archived for 90 days following the event.

    For more information and to register for the conference, please visit Ampio's website here.

    Webcast link:   https://journey.ct.events/view/9d6b477a-99ab-451d-a4da-6fbe4bbd9cb8

    About Ampio Pharmaceuticals

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2035 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contacts

    Investor Relations

    Joe Hassett



    484-686-6600

    Media Contact

    Katie Kennedy



    610-731-1045

     

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  2. ENGLEWOOD, Colo., Feb. 24, 2021 /PRNewswire/ -- Ampio Pharmaceuticals (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced it will host a conference call to discuss the financial results for the year ended December 31, 2020 and provide a corporate business update on Wednesday, March 3, 2021 at 4:30pm EST/ 1:30pm PST.  

    Conference Call & Webcast:

    Wednesday, March 3, 2021, 4:30pm EST / 1:30pm PST

    Domestic:                    888-506-0062  Conference ID # 441054

    International:               973-528-0011  Conference ID # 441054

    Webcast Link:              https://www.webcaster4.com/Webcast/Page/2569/39961

    The conference call will also be available from the Investor Relations section of the Company's website at www.ampiopharma.com and will be archived there shortly after the live event.

    About Ampio Pharmaceuticals

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2035 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contacts

    Investor Relations

    Joe Hassett

     

    484-686-6600

    Media Contact

    Katie Kennedy



    610-731-1045

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-pharmaceuticals-inc-to-report-annual-2020-financial-results-and-provide-corporate-business-update-301234647.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  3. ENGLEWOOD, Colo., Feb. 23, 2021 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced the addition of two new study sites to further the expansion of its ongoing U.S. Phase I clinical trial for inhalation treatment of COVID-19 with Ampion ("AP-014"). Principal Investigator Luciano Lemos-Filho, M.D., in Pulmonary and Critical Care and Medical Center Intensive Care Unit Director at Swedish Hospital in Denver, CO, and Principal Investigator David King, M.D., Medical Director at Bozeman Health Clinical Research in Bozeman, MT, bring additional experience to the study and will accelerate the enrollment of…

    ENGLEWOOD, Colo., Feb. 23, 2021 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced the addition of two new study sites to further the expansion of its ongoing U.S. Phase I clinical trial for inhalation treatment of COVID-19 with Ampion ("AP-014"). Principal Investigator Luciano Lemos-Filho, M.D., in Pulmonary and Critical Care and Medical Center Intensive Care Unit Director at Swedish Hospital in Denver, CO, and Principal Investigator David King, M.D., Medical Director at Bozeman Health Clinical Research in Bozeman, MT, bring additional experience to the study and will accelerate the enrollment of patients in the trial.

    "Patients suffering from life-threatening lung inflammation due to COVID-19 have a desperate need for treatments," said Dr. David King of Bozeman Health Clinical Research. "Ampion's anti-inflammatory effects and its method of action suggest it may offer relief to our patients. We are pleased to be able to work with Ampio Pharmaceuticals in this early-stage trial of Ampion in treating COVID-19 related respiratory distress." 

    "Expanding the trial to include these doctors and their clinical sites will enhance our speed and ability to enroll patients and gather the data needed to prove the safety and potential efficacy of Ampion in treating COVID-19," commented Mike Macaluso, CEO of Ampio Pharmaceuticals. "The trial involves only five days of treatment with Ampion delivered through inhalation, which our research suggests should be sufficient to show clinical effect over the Standard of Care for lung inflammation in COVID-19. Preliminary data from the study shows that Ampion has improved all-cause mortality."

    Nearly 28 million people in the United States have been diagnosed with COVID-19, a full quarter of the cases worldwide. Despite the growing availability of vaccines, therapeutics are, and will continue to be, necessary to treat patients suffering from some of the virus' most challenging and damaging effects, such as systemic inflammation in the lungs.

    In this trial, Ampion is administered to patients by inhalation, allowing the drug to directly target and attenuate inflammation in the lungs. In addition, the trial will enroll 140 patients, randomized 1 to 1, inhaled Ampion versus Standard of Care ("SOC"), which can vary depending on patients' needs but includes any and all of the best procedures and drugs  approved by  the US Food and Drug Administration ("FDA")  or under Emergency Use Authorization through the FDA for use on patients with COVID-19. Depending on disease severity, the SOC for COVID-19 may include supportive care for complications, including supplemental oxygen and advanced organ support, and therapies such as remdesivir or dexamethasone. Safety is the primary end point of the AP-014 study, with various measurements indicative of efficacy as secondary endpoints. Inhalation is a new method for the administration of Ampion which has been cleared for clinical use by the FDA. Recent analysis of preliminary data showed that patients with COVID-19 respiratory complications and administered inhaled Ampion needed less oxygen and showed greater clinical improvement than those receiving the standard of care. Finally, inhaled Ampion also improved all-cause mortality.

    Ampio Pharmaceuticals continues to evaluate additional clinical sites and expects to expand sites in the near term. Ampion is now used in three active investigational new drug ("IND") programs – inhalation, IV, and interarticular.

    About Ampio Pharmaceuticals

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2035 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application (BLA), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contacts

    Investor Relations

    Joe Hassett



    484-686-6600

    Media Contact

    Katie Kennedy



    610-731-1045

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    SOURCE Ampio Pharmaceuticals, Inc.

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  4. ENGLEWOOD, Colo., Feb. 16, 2021 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, announced that the Company will present at The Microcap Rodeo Winter Wonderland Conference on February 17, 2021 at 2:30pm EST.  This conference is virtual.

    To access the webcast, please log in to the following link approximately 10 minutes prior to the start of the presentation time: https://www.webcaster4.com/Webcast/Page/2134/40042.

    About Ampio Pharmaceutical, Inc.                                                             

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of AmpionTM, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, AmpionTM, is backed by an extensive patent portfolio with intellectual property protection extending through 2032, and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to AmpionTM and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that AmpionTM may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Investor Relations

    Joe Hassett



    484-686-6600

    Media Contact

    Sarah May



    215-205-1217

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-pharmaceuticals-inc-to-present-at-upcoming-investor-conference-301228759.html

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  5. ENGLEWOOD, Colo., Feb. 1, 2021 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced early positive data from its ongoing U.S. Phase I controlled, observer-blinded clinical trial of inhaled Ampion versus standard of care for patients with COVID-19 respiratory distress (AP-014).

    An independent statistical analysis revealed patients administered Ampion needed less oxygen and showed greater clinical improvement than those receiving the standard of care for COVID-19 respiratory complications. Ampion improved all-cause mortality in COVID-19 patients with respiratory distress compared to standard of care, and there have been no drug-related serious adverse events.

    On this positive data, Ampio plans to increase the number of patients in the trial from 40 to 140 and has added additional hospitals as study sites. The new hospitals will accelerate the pace of patient enrollment, and the additional data gained from the added patients will help refine and accelerate future clinical trials, as warranted.

    More than 25 million people in the United States have been diagnosed with COVID-19, nearly a quarter of the cases worldwide. Despite the growing availability of vaccines, therapeutics are, and will continue to be, necessary to treat patients suffering from some of the virus' most challenging and damaging effects.

    In the trial, Ampion is administered to patients by inhalation, allowing the drug to directly target and attenuate inflammation in the lungs. This trial will now enroll 140 patients, randomized 1 to 1, inhaled Ampion versus standard of care, with each patient inhaling 8 ml doses of Ampion four (4) times a day for five (5) days. Safety is the primary end point, with various measurements indicative of efficacy as secondary endpoints. Inhalation is a new method for the administration of Ampion, cleared for clinical use by the Federal Drug Administration (FDA). The Safety Monitoring Committee (SMC), analyzing data from the trial, recently determined there were no safety concerns related to inhaled Ampion in COVID-19 patients.

    Preliminary analysis of data from the trial showed Ampion to be an improvement over the standard of care. In fact, patients receiving Ampion treatment required less oxygen, and were stable or exhibited improvement on the Ordinal Scale and NEWS2 scale, compared to the standard of care patients, respectively. The Ordinal Scale was developed by the World Health Organization (WHO) as a way to determine clinical improvement of COVID-19 patients. The NEWS2 was similarly recommended by the National Institute for Health and Care Excellence (NICE) in its guidelines for the management of COVID-19 patients in critical care.

    The analysis also showed Ampion improved all-cause mortality in COVID-19 patients with respiratory distress compared to standard of care patients.

    About Ampio Pharmaceuticals

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032, and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act (BPCIA).

    Forward Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application (BLA), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Investor Relations

    Joe Hassett



    484-686-6600

    Media Contact

    Sarah May



    215-205-1217

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    SOURCE Ampio Pharmaceuticals, Inc.

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  6. ENGLEWOOD, Colo., Jan. 14, 2021 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced its ongoing U.S. Phase I clinical trial for inhalation treatment of COVID-19 with Ampion (AP-014) is 55% enrolled.

    The Phase I clinical trial is ongoing, with the primary focus to evaluate the impact of inhaled Ampion treatment in patients with respiratory distress due to COVID-19. Inhaled Ampion specifically targets inflammation in the lung and is currently being investigated to determine whether its use will improve the clinical outcome for patients with respiratory distress due to COVID-19.

    "We've received amazing feedback from healthcare providers about the improvement seen in patients receiving inhaled Ampion," said Mike Macaluso, CEO of Ampio Pharmaceuticals. "We continue to remain very optimistic at the early, anecdotal evidence regarding the clinical effectiveness of inhaled Ampion in COVID-19 patients, and eagerly await the full results of this trial."

    "Our experience using inhaled Ampion to treat patients with COVID-19 continues to trend positively showing no serious drug-related adverse effects," said Chief of Medical Staff for Penrose-St. Francis Health Services Michael Roshon, MD, PhD. "We look forward to seeing the full results of the study as therapeutics for COVID-19 continue to be in high demand."

    More than 22 million people in the United States have been diagnosed with COVID-19, making up nearly a quarter of the cases worldwide. Despite the growing availability of vaccines, therapeutics are and will continue to be necessary to treat patients suffering from some of the virus' most challenging and damaging effects, including, but not limited to, systemic inflammation in the lungs.

    Currently, the study of inhaled Ampion in COVID-19 patients has exhibited no drug-related serious adverse events (SAE). Feedback from the Safety Monitoring Committee (SMC), analyzing any safety concerns related to inhaled Ampion, is expected later this month.

    In vitro, Ampion interrupts the hyper-active immune response, known as the cytokine storm, which is directly associated with the more serious symptoms of COVID-19. The benefit of this effect from Ampion is currently being studied in multiple human clinical trials. In addition to the U.S. based trial of inhaled Ampion, Ampio Pharmaceuticals has initiated a global study commencing in Israel and the U.S. for patients with moderate to severe COVID-19, assessing the safety and efficacy of intravenous Ampion treatment in both a hospital setting and as a therapy for out-patient care.

    About Ampio Pharmaceuticals

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032, and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act (BPCIA).

    Forward Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application (BLA), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Investor Relations

    Joe Hassett

     

    484-686-6600

    Media Contact

    Sarah May

     

    215-205-1217

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-pharmaceuticals-ongoing-phase-i-clinical-trial-for-inhalation-treatment-of-covid-19-with-ampion-is-55-enrolled-301208409.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  7. ENGLEWOOD, Colo., Jan. 4, 2021 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced an update on the launch of a new global clinical trial for intravenous ("IV") treatment of COVID-19 with Ampion and provided updates on its ongoing U.S. trial for inhalation treatment of COVID-19.

    In vitro, Ampion interrupts the hyper-active immune response, known as the cytokine storm, which is directly associated with the more serious symptoms of COVID-19. The benefit of this effect from Ampion is currently being studied in multiple human clinical trials. The latest updates on these trials include:

    • Initiation of a global clinical trial for IV treatment of COVID-19 patients, including in out-patient settings



      A global study has been initiated in Israel and the U.S. with the focus on patient safety and efficacy, as measured by improvement in the clinical course of the disease and related outcomes for patients with moderate to severe COVID-19. Ampion IV treatment targets systemic inflammation in the body of patients with moderate to severe COVID-19 symptoms. In addition, this study will assess the effect of Ampion IV treatment in both a hospital setting and as a therapy for out-patient care.
    • U.S. based clinical trial underway for inhalation treatment of COVID-19 patients expands to new hospitals



      A Phase I clinical trial is ongoing, with the primary focus to evaluate the impact of inhaled Ampion treatment in patients with respiratory distress due to COVID-19. The trial is currently ongoing with no drug-related serious adverse events ("SAEs") reported to date. The rate of enrollment is expected to increase once requisite front-line workers receive the recently released COVID-19 vaccines. Additional hospitals are also being added to the inhalation study with the goal to conclude enrollment in January. Inhaled Ampion targets inflammation in the lung and is currently being investigated to determine whether its use will improve the clinical outcome for patients with COVID-19. Of note, there have been no drug-related SAEs to date in the inhaled clinical trial.

    "While the vaccine will hopefully help many people avoid the more serious complications of COVID-19, the rollout of vaccines will take time and is unlikely to ever reach 100% of the public," said Michael Macaluso, Chairman and Chief Executive Officer of Ampio Pharmaceuticals. "We will no doubt continue to need treatments to provide the essential relief and improve outcomes for patients. We are especially excited to begin the testing of Ampion for COVID-19 in an outpatient setting."

    About Ampio Pharmaceuticals

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032, and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Investor Relations

    Joe Hassett



    484-686-6600

    Media Contact

    Sarah May



    215-205-1217

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-provides-update-on-clinical-trials-for-ampion-treatment-of-covid-19-patients-301199940.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  8. ENGLEWOOD, Colo., Dec. 29, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, announced today it has received guidance from the U.S Food & Drug Administration ("FDA") regarding the impact of COVID-19 on its Phase III clinical trial for osteoarthritis of the knee ("OAK").

    The COVID-19 health emergency has impacted clinical trials, with over 1,000 studies suspended as a result of the pandemic, including the Phase III clinical trial ("AP-013") for the intra-articular injection of Ampion for treatment of severe OAK. The AP-013 study is being conducted under a Special Protocol Assessment ("SPA") which provides a documented framework for communication and gaining agreement with the FDA to support a commercial Biologics Licensing Application ("BLA").

    In their feedback, the FDA agrees that OAK is a highly prevalent condition that affects millions of patients in the United States. In addition, the FDA provided practical guidance for the AP-013 study to navigate the pandemic, and to complete the study without re-running the trial. The FDA options give us the opportunity to provide additional evidence to support the use of existing data and/or add more patients to the trial. Ampio is thankful for this flexibility, is considering all options and is working to find a solution that will allow us to proceed despite COVID-19 and will present our analysis and proposal to the FDA as soon as possible.

    Answers to questions are available on our website by clicking on the link below:

    https://ampiopharma.com/news/latest-news/

    About Ampio Pharmaceuticals

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").                                                                                                             

    Forward Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Investor Relations

    Joe Hassett



    484-686-6600

    Media Contact

    Sarah May



    215-205-1217

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-receives-feedback-from-the-fda-on-ampios-proposed-modifications-to-the-special-protocol-assessment-for-ampion-treatment-of-severe-osteoarthritis-of-the-knee-301198986.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  9. ENGLEWOOD, Colo., Dec. 17, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology based therapies for prevalent inflammatory conditions, announced today it has completed its Phase I clinical trial and has initiated the first steps for a global Phase II clinical trial for intravenous ("IV") Ampion treatment in COVID-19 patients.

    The Phase I study was a randomized, controlled study of adults hospitalized with severe COVID-19. The primary endpoint for the study was evaluated after a 5-day treatment period, and safety was followed for an additional 3 months. Half of the patients received IV Ampion plus the standard of care ("SOC") for COVID-19 while the other half received SOC alone. The following highlights were observed:

    • Based on data review, the Safety Monitoring Committee ("SMC") found the IV treatment of Ampion to be safe and well-tolerated for 90-days following treatment.
    • The study met its primary safety endpoint after 5 days of IV Ampion treatment and again after 3 months, with no remarkable safety differences between the Ampion treatment and SOC control groups.
    • The study showed promising efficacy with the IV Ampion treatment group seeing stronger clinical improvement than the SOC group as measured by the World Health Organization ("WHO") clinical improvement scale and the National Early Warning Score ("NEWS2"), which is recommended by the National Institute for Health and Care Excellence ("NICE") in its guidelines for the management of COVID-19 patients in critical care.
    • Additionally, Ampion-treated patients showed greater improvement compared to patients treated with the SOC, including anti-viral therapies.

    The beneficial clinical applications for IV Ampion treatment in COVID-19 patients will be further explored using two treatment groups in a larger Phase II study while building on the safety profile from the Phase I study. The following highlights are presented:

    • Clinical sites in Israel will be used concurrently with sites in the United States, as Israel has been recognized by the FDA as capable for sharing knowledge and inspection information to support the safety and efficacy of drugs in the United States.
    • In vitro, Ampion interrupts the hyper-active immune response, known as the cytokine storm, associated with COVID-19 infection. IV Ampion targets systemic inflammation in the body observed with COVID-19 patients, which is being investigated to improve the clinical course of the diseases and outcomes in patients treated with Ampion.
    • The IV Ampion clinical program complements ongoing clinical studies evaluating inhaled Ampion, which targets localized inflammation in the lungs.

    About Ampio Pharmaceuticals

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032, and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Investor Relations

    Joe Hassett



    484-686-6600

    Media Contact

    Sarah May



    215-205-1217

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    SOURCE Ampio Pharmaceuticals, Inc.

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  10. ENGLEWOOD, Colo., Dec. 10, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology based therapies for prevalent inflammatory conditions, announced today that it has entered into two collaborative research agreements to explore new clinical indications for its immunomodulatory drug, Ampion™.

    Rare Inflammatory Pediatric Diseases

    The Company entered into a collaborative research agreement with the oldest and one of the top children's hospitals in the United States whereby both parties will work together and conduct exploratory research to determine whether the anti-inflammatory and signaling pathways of Ampion could play a role in the treatment of certain rare Inflammatory Pediatric Diseases.

    Currently in clinical trials for treatment of inflammation due to osteoarthritis and COVID-19 related acute respiratory distress syndrome (ARDS), Ampion has been shown to reduce inflammation through multiple pathways. The exploratory research conducted under the collaborative research agreement will utilize cell culture models and proteomic, metabolomic, genomic and in silico computational methods as well as in vitro characterization of identified dysregulated signaling pathways in human cultured cell types (e.g. human epithelial cells, microvascular endothelial cells, peripheral blood mononuclear cells (PBMC)).

    Inflammatory Kidney Disease Research with Andrew Terker, M.D., Ph.D.

    Dr. Andrew Terker, a prominent basic research scientist specializing in kidney research at Vanderbilt University Medical Center, has entered into a research collaboration with Ampio in which the immunology based anti-inflammatory properties of Ampion will be investigated as a treatment for acute and chronic kidney disease, extremely common conditions for which new therapies are needed. Dr. Terker's interest in exploring Ampion's anti-inflammatory effects in acute kidney injury (AKI) and chronic kidney disease (CKD) is based on more than a dozen peer-reviewed publications that reported Ampion modulates anti-inflammatory signaling pathways known to be relevant in kidney disease. The FDA has approved three different methods of administration of Ampion: by direct intra articular injection, intravenous administration and by inhalation in the course of clinical trials for the treatment of ARDS in COVID-19 patients, COVID-19 patients requiring supplemental oxygen, and osteoarthritis of the knee. Equally important to Dr. Terker, there have been no drug-related adverse events reported with any method of administration in any Ampion clinical trials.

    About Ampio Pharmaceuticals

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act (BPCIA).

    Forward Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to the safety and efficacy of Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biologics License Application (BLA), the ability of Ampio to enter into partnering or licensing arrangements, current or future clinical trials, changes in business conditions and similar events (including currently unforeseen risks associated with COVID-19), the possibility that Ampion may be used to treat ARDS induced by COVID-19, Ampio's ability to continue as a going concern and its ability to continue to raise funds using its "at-the-market" equity offering or otherwise, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, in Ampio's Annual Report on Form 10-K for the period ended December 31, 2019, and in subsequent reports on Forms 10-Q and 8-K and other filings made by Ampio with the Securities and Exchange Commission. Accordingly, you should not place undue reliance on these forward-looking statements. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Investor Relations

    Joe Hassett



    484-686-6600

    Media Contact

    Sarah May



    215-205-1217

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-enters-into-collaborative-research-agreements-to-explore-additional-clinical-indications-for-its-immunomodulatory-drug-ampion-301190462.html

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  11. ENGLEWOOD, Colo., Dec. 8, 2020 /PRNewswire/ -- Ampio Pharmaceuticals (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, announced today that the Company will conduct its annual meeting in a virtual format only on December 12, 2020 at 9:00 am MST. Additional details regarding the meeting are as follows:

    Annual Meeting Webcast Link and Call-in Number:

    Webcast link: www.virtualshareholdermeeting.com/AMPE2020

    U.S./Canada toll-free number: 1-877-328-2502

    Please note that the call-in line and webcast link will be muted for the duration of the meeting; however, shareholders will be able to submit their votes and/or questions via the webcast as long as they have their 16-digit control number, which was previously provided on their proxy statement.

    An audio replay of the annual meeting will be posted on the Company's website within 24 hours of the meeting (https://ampiopharma.com/investors/presentations-media).

    Forward Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to the safety and efficacy of Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biologics License Application (BLA), the ability of Ampio to enter into partnering or licensing arrangements, current or future clinical trials, changes in business conditions and similar events (including currently unforeseen risks associated with COVID-19), the possibility that Ampion may be used to treat ARDS induced by COVID-19, Ampio's ability to continue as a going concern and its ability to continue to raise funds using its "at-the-market" equity offering or otherwise, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, in Ampio's Annual Report on Form 10-K for the period ended December 31, 2019, and in subsequent reports on Forms 10-Q and 8-K and other filings made by Ampio with the Securities and Exchange Commission. Accordingly, you should not place undue reliance on these forward-looking statements. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Investor Relations

    Joe Hassett



    484-686-6600

    Media Relations

    Sarah May



    215-205-1217

     

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    SOURCE Ampio Pharmaceuticals, Inc.

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  12. ENGLEWOOD, Colo., Dec. 2, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology based therapies for prevalent inflammatory conditions, announced today that its AP-014 Phase I inhaled Ampion™ clinical study in COVID-19 patients is proceeding to full open enrollment following clearance by the Safety Monitoring Committee (SMC), which found Ampion to be safe and well-tolerated after reviewing results from the first three treatment groups. The trial can now accelerate to complete enrollment of the remaining 34 patients at the speed of recruitment.

    "The primary goal of this trial is to confirm the safety of inhaled Ampion, so we are pleased the SMC found no concerns after treatment of the first sets of patients," Michael Macaluso, President and CEO of Ampio Pharmaceuticals. "The enrollment of patients will proceed quickly, perhaps doubling the number of patients enrolled by the end of today.

    "We were also encouraged," continued Macaluso, "by a letter we received from staff at the hospital, sharing the dramatic improvement seen in a patient after using nebulized Ampion. Full confirmation of Ampion's efficacy awaits the conclusion of our clinical trial, but it is heartening to hear good news when it comes to COVID-19."

    In the trial, Ampion is administered to patients by inhalation, allowing the drug to directly target and attenuate inflammation in the lungs, using a hand-held nebulizer for COVID-19 patients early in the disease and non-invasive ventilation (face mask) and mechanical ventilation (intubation) if their disease state is more severe.

    This trial, being conducted in the United States, will enroll 40 patients, randomized 1 to 1, inhaled Ampion versus Standard of Care (SOC), with each patient inhaling 8 ml doses of Ampion four (4) times a day for five (5) days. Safety is the primary end point, and various measurements indicative of efficacy are secondary endpoints. Since inhalation is a new method for the administration of Ampion, cleared for clinical use by the FDA, each of the first three patient groups receiving inhaled Ampion were assessed by the SMC for an additional three days after the five-day treatment period. No safety concerns arose in any of these groups, and, as such, the trial was approved to complete full enrollment.

    In related news, the Journal of Translational Medicine this week published a peer-reviewed paper on the method of action of Ampion, entitled "LMWF5A suppresses cytokine release by modulating select inflammatory transcription factor activity in stimulated PBMC," by G. Thomas, et al. The research provides evidence that Ampion, a low molecular weight fraction of human serum albumin (LMWF5A), reduces pro–inflammatory cytokine release by activating the immunoregulatory transcription factors PPARγ and AhR while also suppressing NF–κB and STAT1α pro–inflammatory pathways.

    "This paper, in a high-impact journal, confirms that Ampion reduces inflammation through multiple pathways, unlike many other anti-inflammatory therapies that target only one," concluded Macaluso. "Inflammation is one of the body's most important survival mechanisms, so suppressing only one pathway merely forces the body to activate other pathways. Ampion targets multiple pathways simultaneously to interrupt the destructive cycle of inflammation and disease observed in many different inflammatory conditions."

    About Ampio Pharmaceutical

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act (BPCIA).

    Forward Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to the safety and efficacy of Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biologics License Application (BLA), the ability of Ampio to enter into partnering or licensing arrangements, current or future clinical trials, changes in business conditions and similar events (including currently unforeseen risks associated with COVID-19), the possibility that Ampion may be used to treat ARDS induced by COVID-19, Ampio's ability to continue as a going concern and its ability to continue to raise funds using its "at-the-market" equity offering or otherwise, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, in Ampio's Annual Report on Form 10-K for the period ended December 31, 2019, and in subsequent reports on Forms 10-Q and 8-K and other filings made by Ampio with the Securities and Exchange Commission. Accordingly, you should not place undue reliance on these forward-looking statements. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Investor Relations

    Joe Hassett



    484-686-6600

    Media Relations

    Sarah May



    215-205-1217

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    SOURCE Ampio Pharmaceuticals, Inc.

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  13. ENGLEWOOD, Colo., Nov. 25, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, announced today the following updates:

    • Patients experiencing respiratory distress due to COVID-19:  In the Phase I inhaled Ampion™ clinical trial (AP-014), the third of three initial safety groups of patients have completed their five days of treatment and three days of follow up for Safety Monitoring Committee (SMC) review (as inhalation is a new delivery method of Ampion cleared for clinical use by the FDA). Once the SMC provides confirmation regarding no safety concerns for this third group, the trial will accelerate to complete the remaining thirty-four patients at the speed of recruitment with additional hospital groups added as required to support enrollment.
    • Patients with severe osteoarthritis of the knee (OAK):  The amendment to the OAK Phase III clinical trial (AP-013), that harmonizes the FDA agreement on the Special Protocol Assessment (SPA) with FDA guidance for clinical trials on hold due to COVID-19, has been received by the FDA. The FDA notified the Company that a formal response will be provided by the end of this year.

    About Ampio Pharmaceutical

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act (BPCIA).

    Forward Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to the safety and efficacy of Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biologics License Application (BLA), the ability of Ampio to enter into partnering or licensing arrangements, current or future clinical trials, changes in business conditions and similar events (including currently unforeseen risks associated with COVID-19), the possibility that Ampion may be used to treat ARDS induced by COVID-19, Ampio's ability to continue as a going concern and its ability to continue to raise funds using its "at-the-market" equity offering or otherwise, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, in Ampio's Annual Report on Form 10-K for the period ended December 31, 2019, and in subsequent reports on Forms 10-Q and 8-K and other filings made by Ampio with the Securities and Exchange Commission. Accordingly, you should not place undue reliance on these forward-looking statements. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Investor Relations

    Joe Hassett



    484-686-6600

    Media Relations

    Sarah May

     

    215-205-1217

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-updates-regulatory-and-clinical-trial-events-301180238.html

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  14. ENGLEWOOD, Colo., Nov. 17, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology based therapies for prevalent inflammatory conditions, announced today that the third group in the Phase I inhaled Ampion™ clinical study is being treated following clearance by the Safety Monitoring Committee (SMC) who found Ampion to be safe and well-tolerated after reviewing the results from the first and second treatment groups.

    Michael Macaluso, Ampio's, President and CEO, clarified specific features of this clinical trial:

    • "Ampion is being administered to patients by inhalation, allowing the drug to directly target and attenuate inflammation in the lungs, using a hand-held nebulizer for COVID-19 patients early in the disease and non-invasive ventilation (face mask) and mechanical ventilation (intubation) if their disease state is more severe.
    • This US based study will enroll 40 patients, randomized 1 to 1, inhaled Ampion versus Standard of Care (SOC), with each patient inhaling 8 ml doses of Ampion four (4) times a day for five (5) days. Safety is the primary end point and various measurements indicative of efficacy are secondary endpoints.
    • Each of the first three patient groups receiving inhaled Ampion are assessed by the SMC for an additional three days after the 5 day treatment period (as inhalation is a new method of administration of Ampion cleared for clinical use by the FDA) and if no safety concerns arise for this third group, the trial will accelerate to complete enrollment of the remaining 34 patients at the speed of recruitment."

    Mr. Macaluso further noted, "The FDA has now cleared two types of administration of Ampion (i.e., inhalation and intravenous) for treatment of COVID-19 patients. In addition, a third method of administration, direct injection into the knee for patients suffering from severe osteoarthritis of the knee, supports the Company's belief that Ampion is a platform drug, potentially useful for a number of inflammatory diseases throughout the body. We are continuing our  investigation of conducting a similar inhalation study overseas that we expect will  run in close proximity with the US study. We will provide an update with more information as it develops."

    About Ampio Pharmaceutical

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act (BPCIA).

    Forward Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to the safety and efficacy of Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biologics License Application (BLA), the ability of Ampio to enter into partnering or licensing arrangements, current or future clinical trials, changes in business conditions and similar events (including currently unforeseen risks associated with COVID-19), the possibility that Ampion may be used to treat ARDS induced by COVID-19, Ampio's ability to continue as a going concern and its ability to continue to raise funds using its "at-the-market" equity offering or otherwise, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, in Ampio's Annual Report on Form 10-K for the period ended December 31, 2019, and in subsequent reports on Forms 10-Q and 8-K and other filings made by Ampio with the Securities and Exchange Commission. Accordingly, you should not place undue reliance on these forward-looking statements. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Investor Relations

    Joe Hassett



    484-686-6600

    Media Relations

    Sarah May

       

    215-205-1217

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampios-phase-i-study-for-inhaled-ampion-advances-to-3rd-group-of-covid-19-patients-with-respiratory-distress-301174848.html

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  15. ENGLEWOOD, Colo., Nov. 10, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology based therapies for prevalent inflammatory conditions, announced today that the second group in the Phase I inhaled Ampion™ clinical study is being treated following clearance by the Safety Monitoring Committee (SMC) who found Ampion to be safe and well-tolerated after reviewing the results from the first treatment group.

    Michael Macaluso, Ampio's, President and CEO, clarified specific features of this clinical trial:

    • "Ampion will be administered to patients by inhalation, allowing the drug to directly target and attenuate inflammation in the lungs, using a hand-held nebulizer for COVID-19 patients early in the disease and non-invasive ventilation (face mask) and mechanical ventilation (intubation) if their disease state is more severe.
    • This US study will enroll 40 patients, randomized 1 to 1, inhaled Ampion versus Standard of Care (SOC), with each patient inhaling 8 mL doses of Ampion four (4) times a day for five (5) days. Safety is the primary end point and various measurements indicative of efficacy are secondary endpoints.
    • Each of the first three patient groups receiving inhaled Ampion will be assessed by the SMC for an additional three days after the 5 day treatment period (as inhalation is a new method of administration of Ampion cleared for clinical use by the FDA) and if no safety concerns arise, open enrollment at the speed of recruitment will follow the remainder of the 40 patients."

    Mr. Macaluso further noted, "The FDA has now cleared two types of administration of Ampion for treatment of COVID-19 patients, inhalation and intravenous. In addition, a third method of administration, direct injection into the knee for patients suffering from severe osteoarthritis-of-the-knee, supports the Company's belief that Ampion is a platform drug, potentially useful for a number of inflammatory diseases throughout the body. We are currently investigating a similar inhalation study overseas that we are planning to run in close proximity with the US study. We will provide an update with more information as it develops."

    About Ampio Pharmaceutical

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act (BPCIA).

    Forward Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to the safety and efficacy of Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biologics License Application (BLA), the ability of Ampio to enter into partnering or licensing arrangements, current or future clinical trials, changes in business conditions and similar events (including currently unforeseen risks associated with COVID-19), the possibility that Ampion may be used to treat ARDS induced by COVID-19, Ampio's ability to continue as a going concern and its ability to continue to raise funds using its "at-the-market" equity offering or otherwise, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, in Ampio's Annual Report on Form 10-K for the period ended December 31, 2019, and in subsequent reports on Forms 10-Q and 8-K and other filings made by Ampio with the Securities and Exchange Commission. Accordingly, you should not place undue reliance on these forward-looking statements. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Investor Relations

    Joe Hassett



    484-686-6600

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampios-phase-i-study-for-inhaled-ampion-advances-to-2nd-group-of-covid-19-patients-with-respiratory-distress-301170318.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  16. ENGLEWOOD, Colo., Nov. 5, 2020 /PRNewswire/ -- Ampio Pharmaceuticals (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology based therapies for prevalent inflammatory conditions, today, at 4:30pm EST, will provide an update and overview of its clinical development pipeline / activities and its financial results for the third quarter ended September 30, 2020. 

    Attending the webinar from Ampio will be, Mr. Michael Macaluso (President and CEO), Dr. David Bar-Or (Director and Founder), Ms. Laura Goldberg (Vice President) and Mr. Daniel Stokely (CFO).  The key areas of focus will be as follows:

    COVID-19 Platform / Pipeline Overview and Update

    • AP-014 (inhaled) and AP-016 (intravenous) clinical trial update
    • Possibility of obtaining an Emergency Use Authorization (EUA) from the FDA for inhaled Ampion
    • Discussion of the differences between Ampion vs. other therapeutic options for COVID-19

    OAK Clinical Trial 2020 Timeline / Update

    • Ampio's Osteoarthritis of the Knee (OAK) Phase III trial being conducted under a Special Protocol Assessment (SPA) with the FDA has been paused as a result of COVID-19
    • FDA released "FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic" in April 2020
    • FDA released "Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency" in June 2020
    • Ampio harmonizes steps for OAK Phase III trial with the FDA guidance and submitted an SPA amendment to the FDA

    Financial Update

    As of September 30, 2020, Ampio had $9.4 million of cash and cash equivalents, as compared to cash and cash equivalents of $6.5 million as of December 31, 2019.

    For the third quarter of 2020, research and development costs were $1.7 million, down 52% from $3.4 million for the same period in 2019. This decrease was primarily attributable to a decrease in clinical trial and sponsored research costs. Ampio expects clinical trial and sponsored research costs to increase during the fourth quarter of fiscal 2020 due to the AP-014 inhaled Ampion study. 

    Operations / manufacturing expenses increased $190,000 in the current quarter, when compared to the same period in 2019.

    General and administrative costs decreased $98,000, or 5.6%, from $1.7 million for the same period in 2019.

    Ampio reported a net loss for the third quarter of $3.4 million compared to a net loss of $7.2 million for the same period in 2019.

    To access the webinar, please log in to https://www.webcaster4.com/Webcast/Page/2569/38512 approximately 10 minutes prior to the start of the call.  To ask a question, please dial in to 888-632-3385 (U.S.) or 785-424-1673 (International) and use the Participant Entry Code: 47668. Please note that you can also ask a question through the webinar platform.

    A replay of this presentation will be available two hours after the end of the call by dialing 877-481-4010 (U.S.) or 919-882-2331 (International).  Replay Passcode: 38512

    Forward Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to the safety and efficacy of Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biologics License Application (BLA), the ability of Ampio to enter into partnering or licensing arrangements, current or future clinical trials, changes in business conditions and similar events (including currently unforeseen risks associated with COVID-19), the possibility that Ampion may be used to treat ARDS induced by COVID-19, Ampio's ability to continue as a going concern and its ability to continue to raise funds using its "at-the-market" equity offering or otherwise, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, in Ampio's Annual Report on Form 10-K for the period ended December 31, 2019, and in subsequent reports on Forms 10-Q and 8-K and other filings made by Ampio with the Securities and Exchange Commission. Accordingly, you should not place undue reliance on these forward-looking statements. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Investor Relations

    Joe Hassett



    484-686-6600

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  17. ENGLEWOOD, Colo., Nov. 2, 2020 /PRNewswire/ -- Ampio Pharmaceuticals (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology based therapies for prevalent inflammatory conditions, announced today that the Company will present a business and financial update webinar on Thursday, November 5, 2020 at 4:30 pm EST.

    Attending the conference call from Ampio will be Mr. Michael Macaluso (President and CEO), Dr. David Bar-Or (Director and Founder), Ms. Laura Goldberg (Vice President) and Mr. Daniel Stokely (CFO). The business update portion of the call will consist of a COVID-19 platform update from Dr. David Bar-Or and an update on the OAK Trial from Laura Goldberg.  In addition to the business update, Daniel Stokely, CFO, will present a third quarter financial update.

    To access the webinar, please log in to https://www.webcaster4.com/Webcast/Page/2569/38512 approximately 10 minutes prior to the start of the call.  To ask a question, please dial in to 888-632-3385 (U.S.) or 785-424-1673 (International) and use the Participant Entry Code: 47668. Please note that you can also ask a question through the webinar platform.

    A replay of this presentation will be available two hours after the end of the call by dialing 877-481-4010 (U.S.) or 919-882-2331 (International).  Replay Passcode: 38512

    Forward Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Investor Relations

    Joe Hassett  



    484-686-6600

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    SOURCE Ampio Pharmaceuticals, Inc.

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  18. ENGLEWOOD, Colo., Oct. 28, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology based therapies for prevalent inflammatory conditions, announced today the Company has begun recruiting and enrolling patients in a Phase I multi-center, randomized, controlled trial for a total of 40 patients that will assess the safety and efficacy of inhaled Ampion added to the standard of care ("SOC") for COVID-19 infected patients hospitalized for respiratory distress. Dosing of patients will begin at Penrose Hospital in Colorado Springs, Colorado and will expand enrollment to other hospitals in the near future.

    ENGLEWOOD, Colo., Oct. 28, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology based therapies for prevalent inflammatory conditions, announced today the Company has begun recruiting and enrolling patients in a Phase I multi-center, randomized, controlled trial for a total of 40 patients that will assess the safety and efficacy of inhaled Ampion added to the standard of care ("SOC") for COVID-19 infected patients hospitalized for respiratory distress. Dosing of patients will begin at Penrose Hospital in Colorado Springs, Colorado and will expand enrollment to other hospitals in the near future.

    Michael Macaluso, Ampio's CEO clarified specific features of this clinical trial:

    • Ampion will be administered to COVID-19 patients by inhalation, allowing the drug to directly target and attenuate inflammation in the lungs, as administered by either a hand-held nebulizer for COVID-19 patients with mild to moderate disease, or by non-invasive ventilation (face mask) and mechanical ventilation (intubation) in patients impacted with more severe disease.
    • This US study will enroll 40 patients, randomized 1 to 1, Ampion in addition to SOC versus SOC alone. Each patient in the treatment arm will inhale 8 mL doses of Ampion four (4) times a day for five (5) days. Safety is the primary end-point and various measurements indicative of efficacy are secondary endpoints.
    • The first three patients inhaling Ampion will be assessed by a Safety Monitoring Committee for an additional three days after the 5 day treatment period, as required by the protocol, as inhalation is a new method of administration of Ampion approved for clinical use by the FDA. If no safety concerns arise, then open enrollment at the speed of recruitment will follow for the remaining patients.

    Mr. Macaluso further noted " The FDA has now granted two separate INDs and protocols of administration of Ampion for the treatment for COVID-19 patients, inhalation and intravenous, and a third method of administration, by direct intra-articular injection into the knee for patients suffering from severe osteoarthritis-of-the-knee. These various indications and modes of administration of Ampion strengthens the Company's belief that Ampion is a platform drug, which is potentially useful for a number of additional inflammatory conditions. We are currently investigating the possibility of conducting a series of similar inhalation studies world-wide that would run concurrently with the US study. We will provide an update to our shareholders with more information as it develops."

    About Ampio Pharmaceutical

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032, and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward Looking Statements 

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Dan Stokely, CFO

    Phone: (720) 437-6500



    Ampio Pharmaceuticals, Inc.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-begins-phase-1-clinical-trial-of-inhaled-ampion-for-covid-19-patients-with-respiratory-distress-301161493.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  19. ENGLEWOOD, Colo., Oct. 26, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology based therapies for prevalent inflammatory conditions, announced today that the Company will present at the 2020 MedTech Innovation Forum hosted by Roth Capital Partners on Wednesday, October 28, 2020.

    The Company's presentation will (i) review preliminary results from the randomized, controlled study of intravenous Ampion for treatment of hospitalized COVID-19 infected adult patients requiring supplemental oxygen and (ii) further discuss its future COVID-19 plans. Ampion addition to standard of care ("SOC") was compared to patients treated with the SOC including anti-viral therapy ("remdesivir"). Safety was determined by presence of adverse events during the trial and indications of efficacy was determined by the Ordinal Scale, a measure developed by the WHO (a range of 0-8, with 0 defined as uninfected with no clinical or virological signs of infection and 8 denoting death) and calculated as a change from admission to discharge or at the time of discharge from the hospital.

    The primary end-point was safety and, as previously reported, there were no drug related adverse events for a period of 5 days subsequent to the treatment with Ampion. The secondary end point was improvement in the score as measured by the Ordinal Scale. Ampion addition to the SOC compared to the SOC alone or SOC plus remdesivir, demonstrated that the addition of Ampion to the SOC resulted in better average outcomes (reduction in 3 points for Ampion+ SOC versus 1.5 and 2.25 points for SOC and SOC+remdesivir, respectively). Average scores as measured by the Ordinal Scale at the time of discharge from the hospital were also better for Ampion+SOC compared to the other groups (a score of 1 for Ampion +SOC versus 2.75 and 1.75 for SOC and SOC+remdesivir, respectively).

    About Ampio Pharmaceutical

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032, and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward Looking Statements    

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Dan Stokely, CFO

    Phone: (720) 437-6500



    Ampio Pharmaceuticals, Inc.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-presents-at-roth-capital-partners-2020-medtech-innovation-forum-focusing-on-covid-19-clinical-trial-activities-301159523.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  20. ENGLEWOOD, Colo., Oct. 8, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced the publication of a scientific manuscript on Ampion™ effects on peripheral blood monocytes ("PBMC") in a preprint report (Ampion suppresses cytokine release by modulating select inflammatory transcription factor activity in stimulated PBMC, DOI: https://doi.org/10.21203/rs.3.rs-86515/v1).

    In this report, evidence is provided that Ampion reduces pro-inflammatory cytokine release by activating the immunoregulatory transcription factors PPARγ and AhR. In addition, data indicates that Ampion suppresses NF-κB and STAT1α pro-inflammatory pathways, suggesting that Ampion acts through these mechanisms to decrease pro-inflammatory transcription factor activity and subsequent inflammatory cytokine production.

    This publication adds to the growing evidence of the important anti-inflammatory activities of Ampion in various inflammation related conditions, including the dysregulated immune response observed in severe COVID-19 infected patients. A recurring theme across all clinical trials with Ampion, including our recent Phase I trial for intravenous ("IV") Ampion treatment for COVID-19 patients, is that this anti-inflammatory biologic has been safe and well-tolerated with no serious drug related adverse events. https://ampiopharma.com/news/ampio-reports-positive-results-in-early-trial-for-iv-ampion-treatment-in-covid-19-patients/  

    About Inflammatory Diseases                                                                                           Inflammation refers to a biological response to stimuli interpreted by the body to have a potentially harmful effect. Inflammatory disorders that result in a dysregulated immune response by attacking the body's own cells or tissues may result in chronic pain, tissue damage and loss of function. Inflammation plays a major role in many disease processes including allergy, asthma, autoimmune disorders such as hepatitis, inflammatory bowel disease, transplant rejection and more.

    About Ampio Pharmaceutical

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032, and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").                                                        

    Forward-Looking Statements                                                                                                     Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Dan Stokely, CFO

    Phone: (720) 437-6500



    Ampio Pharmaceuticals, Inc.

     

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    SOURCE Ampio Pharmaceuticals, Inc.

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  21. DENVER, Sept. 29, 2020 /PRNewswire/ -- Theralink Technologies (OTC:OBMP("Theralink" or the "Company"), a molecular profiling company specializing in patented, biomarker assay services that target multiple areas of oncology, today announced the appointment of Thomas E. Chilcott, III CPA as Chief Financial Officer, effective September 24, 2020.

    Mr. Chilcott joins Theralink Technologies with over 30 years of financial and operational experience in publicly traded and privately-owned companies. Throughout his career, Mr. Chilcott has provided guidance on capital formation, M&A, restructurings, and creating shareholder value. From 2017 to 2019, Mr. Chilcott was the Chief Financial Officer, Secretary and Treasurer of Ampio Pharmaceuticals, Inc…

    DENVER, Sept. 29, 2020 /PRNewswire/ -- Theralink Technologies (OTC:OBMP("Theralink" or the "Company"), a molecular profiling company specializing in patented, biomarker assay services that target multiple areas of oncology, today announced the appointment of Thomas E. Chilcott, III CPA as Chief Financial Officer, effective September 24, 2020.

    Mr. Chilcott joins Theralink Technologies with over 30 years of financial and operational experience in publicly traded and privately-owned companies. Throughout his career, Mr. Chilcott has provided guidance on capital formation, M&A, restructurings, and creating shareholder value. From 2017 to 2019, Mr. Chilcott was the Chief Financial Officer, Secretary and Treasurer of Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biotechnology company primarily focused on the development of therapies to treat prevalent inflammatory conditions. During his tenure at Ampio, he was instrumental in raising capital and leading the accounting and finance department including all SEC filings. Additionally, Mr. Chilcott, a CPA, was the President of Chilcott Consulting Group where for over 10 years he assisted many public and private biotechnology, healthcare and technology companies. 

    "We are pleased to welcome Tom to the Theralink team during this critical inflection point in our company's history," said Mick Ruxin, M.D., President and CEO of Theralink Technologies. "Tom will not only add to our team extensive public company experience in healthcare, but also a deep understanding of 3rd party reimbursement, capital formation and leadership, which will be critical to the sustained growth of our company in the future. I look forward to working closely with Tom as we execute on our strategic goals, growth and delivering shareholder value."

    Mr. Thomas Chilcott, newly appointed Chief Financial Officer, commented, "I look forward to complimenting the existing team at Theralink with my finance and operational experience. Theralink recently achieved a significant milestone of CLIA certification for its laboratory. We will immediately begin preparing to receive, test and bill for patient's breast cancer tumor specimens during the fourth quarter of this year."

    About Theralink Technologies, Inc.

    Theralink® Technologies is a CLIA accredited, proteomics-based, molecular profiling and precision medicine company located in Golden, Colorado. Through its unique and patented phosphoprotein and protein biomarker platform and CLIA assay, Theralink's technology targets multiple areas of oncology and drug development. Theralink provides precision oncology data through its powerful Theralink® Reverse Phase Protein Array (RPPA) assays to assist the biopharmaceutical industry and clinical oncologists in identifying likely responders and non-responders to both FDA-approved and investigational drug treatments. Theralink intends to help improve cancer outcomes for patients, reveal therapeutic options for oncologists, and support biopharmaceutical drug development by using a beyond-genomics approach to molecular profiling that directly measures drug target levels and activity. For more information, please visit www.theralink.com.

     

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  22. ENGLEWOOD, Colo., Sept. 21, 2020 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE:AMPE) (the "Company") announces the receipt of an Investigational New Drug ("IND") from the U.S. Food and Drug Administration ("FDA"), allowing the Company to proceed with clinical trials for the use of AmpionTM as an inhalation therapy for respiratory distress due to COVID-19 infection.

    Expanding on the recently successful Phase I trial that administered Ampion intravenously to COVID-19 patients (https://ampiopharma.com/news/ampio-reports-positive-results-in-early-trial-for-iv-ampion-treatment-in-covid-19-patients/), the current Phase I trial of inhaled Ampion will be a multi-center, randomized, controlled trial for a total of 40 patients, and will assess the safety and efficacy of inhaled Ampion added to the standard of care ("SOC") for COVID-19 infected patients hospitalized for respiratory distress. Ampion will be delivered by inhalation, allowing the drug to directly target and attenuate inflammation in the lungs that can lead to respiratory failure. This approved clinical trial will study the effects of inhaled Ampion while emphasizing early intervention treatment throughout the clinical progression of COVID-19 infection. Ampion will be delivered by a hand-held nebulizer for inhalation by patients with less severe cases of respiratory illness and through mechanical ventilators to those patients who have progressed to severe respiratory distress syndrome ("ARDS").

    The FDA relied on safety and efficacy data from comprehensive preclinical laboratory studies provided by Ampio to Grant this IND. Toxicology studies demonstrated that Ampion is safe for inhalation, and extensive laboratory data indicates that Ampion can effectively reduce signaling proteins responsible for tissue damage and pulmonary complications. These studies also revealed that Ampion can effectively increase signaling molecules required for tissue repair and healing in the lungs. Ampion's mechanism of action may interrupt the pulmonary disease process and provide much needed relief and recovery for patients suffering from shortness of breath and respiratory illness related to COVID-19 infection.

    The current IND along with Ampio's active INDs for the introduction of Ampion intravenously and by intraarticular injection builds upon Ampion's potential as a platform drug, treating multiple conditions characterized by inflammation.  A recurring theme across all clinical trials with Ampion is that this anti-inflammatory biologic has been safe and well-tolerated with no serious drug related adverse events.

    About Inflammatory Diseases

    Inflammation refers to a biological response to stimuli interpreted by the body to have a potentially harmful effect. Inflammatory disorders that result in a dysregulated immune response by attacking the body's own cells or tissues may result in chronic pain, tissue damage and loss of function. Inflammation plays a major role in many disease processes including allergy, asthma, autoimmune disorders such as hepatitis, inflammatory bowel disease, transplant rejection and more.

    About Ampio Pharmaceuticals

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead product candidate, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032 and is eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward-Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "may," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion™ and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, the timing and outcome of clinical trials, and that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Daniel G. Stokely, CFO

    Phone: (720) 437-6500

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    SOURCE Ampio Pharmaceuticals, Inc.

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  23. ENGLEWOOD, Colo., Sept. 14, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced that Michael Roshon, MD, PhD, Chief of Staff at Penrose-St. Francis Hospital in Colorado Springs, Colorado, who served as Principal Investigator of the just completed Phase I trial of intravenous Ampion™ for treatment of COVID-19 patients, and David Bar-Or, MD, founder of Ampio Pharmaceuticals, were interviewed about those clinical results on a Colorado affiliate FOX news segment titled, "Colorado Drug shows promise against COVID-19", which can be viewed in its entirety at:

    ENGLEWOOD, Colo., Sept. 14, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced that Michael Roshon, MD, PhD, Chief of Staff at Penrose-St. Francis Hospital in Colorado Springs, Colorado, who served as Principal Investigator of the just completed Phase I trial of intravenous Ampion™ for treatment of COVID-19 patients, and David Bar-Or, MD, founder of Ampio Pharmaceuticals, were interviewed about those clinical results on a Colorado affiliate FOX news segment titled, "Colorado Drug shows promise against COVID-19", which can be viewed in its entirety at:

    https://kdvr.com/video/colorado-drug-shows-promise-against-covid-19/5844056/

    About Ampio Pharmaceuticals

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032, and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").                                                        

    Forward-Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Dan Stokely, CFO

    Phone: (720) 437-6500

     

    Ampio Pharmaceuticals, Inc.

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    SOURCE Ampio Pharmaceuticals, Inc.

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  24. ENGLEWOOD, Colo., Sept. 9, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced positive results in early trial for intravenous ("IV") AmpionTM treatment for COVID-19 patients. We believe Ampion may be effective in interrupting the inflammatory cascade associated with COVID-19 and improving the clinical course and outcome in patients treated with Ampion. 

    The Phase I trial was led by Michael Roshon, MD, PhD, Chief of Staff at Penrose-St. Francis Hospital in Colorado Springs, Colorado. The trial was a randomized, controlled study of adults hospitalized, confirmed SARS-COV-2 ("COVID-19") positive by PCR test and receiving supplemental oxygen. Patients were randomized 1:1 to receive IV Ampion treatment or standard of care, including anti-viral therapies, such as Remdesivir or convalescent plasma, both approved by the FDA under emergency use authorization ("EUA") as standard of care.  The majority of the patients in the control group were prescribed Remdesivir anti-viral treatment while no patients in the IV Ampion group received that anti-viral therapy.

    The study met its primary endpoint for the safety and tolerability of IV Ampion treatment, with no remarkable difference in the incidence, frequency, and severity of adverse events between IV Ampion and standard of care.

    All patients treated with IV Ampion improved after treatment. At hospital discharge, the IV Ampion treatment group had a stronger clinical improvement than the COVID standard of care control group, as determined by both the World Health Organization ("WHO") clinical improvement scale1 and the National Early Warning Score ("NEWS2")2, which is recommended by the National Institute for Health and Care Excellence ("NICE") in its guidelines for the management of COVID-19 patients in critical care.

    Treatment options for COVID-19 are limited and the country continues to observe rising numbers of infection. These Phase I study results provide encouraging results that IV Ampion may be a safe and effective treatment for COVID-19 infected patients admitted to the hospital and needing supplemental oxygen.

    Patients will be followed over the upcoming months to complete the safety endpoint assessments for the Phase 1 clinical trial. Safety and efficacy results will be submitted to a peer-reviewed scientific journal and provide the basis for performing a Phase II/III trial with IV Ampion.

    1 WHO Clinical Improvement Scale: https://www.who.int/blueprint/priority-diseases/key-action/COVID-19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf

    2 NEWS Critical Intervention Scale: https://www.mdcalc.com/national-early-warning-score-news-2

    About Ampio Pharmaceutical

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward-Looking Statements                                                                                              

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," "may," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion™ and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that IV Ampion may be effective in interrupting the inflammatory cascade associated with COVID-19, and that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Dan Stokely, CFO

    Phone: (720) 437-6500



    Ampio Pharmaceuticals, Inc.

    AMPE

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-reports-positive-results-for-ampion-treatment-in-covid-19-patients-301126438.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  25. ENGLEWOOD, Colo., Sept. 4, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions announces the following: 

    • Enrollment has been completed for the AmpionTM Phase I US based clinical trial for IV treatment of COVID-19 patients requiring supplemental oxygen. The final results from the 5-day treatment will be reported when the Safety Monitoring Committee ("SMC") and the Principal Investigator complete their evaluations which we expect should occur within the next week.
    • The current Ampion Phase III clinical trial ("AP-013") of an intra-articular injection of Ampion for treatment of severe OAK, was paused in April 2020 due to significant logistical issues associated with the COVID-19 pandemic. Recently, the FDA has provided guidance specifically designed to assist the pharmaceutical industry with viable options for evaluating data from clinical trials which were adversely impacted by the pandemic. In order to remain in compliance with such guidance, we will continue to remain blinded to the trial results achieved prior to pausing the trial, however, we are confident there will be sufficient objective information to support the submission of our proposal to the FDA. Our plan is to have this proposal completed and sent to the FDA early in the 4th quarter 2020.

    About Ampio Pharmaceuticals 

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward Looking Statements  

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion™ and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Dan Stokely, CFO

    Phone: (720) 437-6500



    Ampio Pharmaceuticals, Inc.

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    SOURCE Ampio Pharmaceuticals, Inc.

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  26. ENGLEWOOD, Colo., Aug. 19, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, provides updates regarding the following clinical trials:

    • Ampion Phase I clinical trial for intravenous ("IV") treatment of COVID-19 patients:

      The initial safety assessments are complete and the trial is cleared to enroll the remaining patients for the Phase I US based clinical trial evaluating a 5-day IV AmpionTM treatment for COVID-19 patients requiring supplemental oxygen. The results were reviewed by an independent Safety Monitoring Committee, comprised of four physicians, who found Ampion to be safe and well-tolerated, and who authorized the trial to move to completion. Additional details of the trial can be found on clinicaltrials.gov (NCT04456452).   
    • Ampion IND application for inhalation treatment of COVID-19 patients:

      The FDA requested comprehensive tests on the safety of nebulized Ampion at various doses. The results of these tests have been reviewed by independent toxicologists who found no evidence of toxicity in preclinical trials, even at extreme doses, and this extensive data has been submitted to the FDA. A clinical trial protocol for treating patients who have respiratory distress due to COVID-19 with nebulized Ampion has already been submitted and is being reviewed by the FDA. The addition of this safety data is expected to complete our IND application. 

    About Ampio Pharmaceuticals

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032, and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," "may," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, and that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Dan Stokely, CFO

    Phone: (720) 437-6500



    Ampio Pharmaceuticals, Inc.

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-provides-update-on-covid-19-clinical-trial-activities-301114581.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  27. ENGLEWOOD, Colo., July 23, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE) (the "Company" or "Ampio"), is a biopharmaceutical company focused on the development and advancement of immunology-based therapies for prevalent inflammatory conditions. As part of this program, the Company is actively working on the development of therapies for patients infected with the SARS-CoV-2 virus ("COVID-19").

    Patients are being dosed in a Phase 1 United States based clinical trial evaluating a 5-day intravenous ("IV") AmpionTM treatment for COVID-19 patients requiring supplemental oxygen. The primary endpoint for this randomized, controlled study will evaluate the safety and tolerability of IV Ampion treatment in adult COVID-19 patients requiring oxygen supplementation. Additional details of the trial can be found on ClinicalTrials.gov (NCT04456452).

    Ampion is an immunomodulatory anti-inflammatory agent that has been shown to inhibit the expression of proinflammatory cytokines, including tumor necrosis factor alpha (TNFα), by repressing their transcription. Proinflammatory cytokines like TNFα are believed to play a key role in the overactive inflammatory response, or cytokine storm, in the lungs of COVID-19 patients who require supplemental oxygen. Ampion may be effective in interrupting the inflammatory cascade associated with COVID-19 and improve the clinical course and outcome of patients. A manuscript detailing this mechanism of action titled, "The novel immunomodulatory biologic LMWF5A (Ampion) for pharmacological attenuation of the "cytokine storm" in COVID-19 patients: a hypothesis", has been published in a peer-reviewed journal ( 10.1186/s13037-020-00248-4).

    "Our understanding of COVID-19 continues to evolve, and we are pleased to partner with Ampio in this trial to assess Ampion's potential as a treatment in the fight against COVID-19. It is clear that modulation of the immune response to COVID-19 is one of the most promising therapeutic targets.  We are very interested in investigating Ampion's effect on inflammation in this setting," said trial Principal Investigator Dr. Michael Roshon, MD, PhD, Chief of Staff at Penrose-St. Francis Hospital in Colorado Springs, Colorado.

    About Ampio Pharmaceutical

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032, and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward-Looking Statements                                                                                              

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion™ and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Dan Stokely, CFO

    Phone: (720) 437-6500



    Ampio Pharmaceuticals, Inc.

    AMPE

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  28. ENGLEWOOD, Colo., July 20, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the development and advancement of immunology based therapies for prevalent inflammatory conditions, today announced the publication "Insights into pediatric multi-system inflammatory syndrome and COVID-19."

    "This newly described syndrome in children," explained Ampio founder and principle author, Dr. David Bar-Or, MD, "resembles Kawasaki Disease and exhibits many signs, symptoms and pathology that could be treated by intravenous AmpionTM either alone or in combination with intravenous immunoglobulins ("IVIG")." A commentary describing the involvement of prostaglandins and cytokines in this syndrome and the Ampion in-vitro experiments demonstrating beneficial effects for the same, just published in Clinica Chimica Acta: 510 (2020) 121-122, can be accessed at: https://authors.elsevier.com/c/1bPpm2G2LyTE3. Ampio continues to evaluate the potential use of Ampion in this condition as a safe, effective and alternative/addition to existing therapies.

    About Ampio Pharmaceutical

    Ampio Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and advancement of immunology-based therapies for prevalent inflammatory conditions. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032, and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward Looking Statements 

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat acute respiratory distress syndrome ("ARDS") induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Dan Stokely, CFO

    Phone: (720) 437-6500



    Ampio Pharmaceuticals, Inc.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-reports-a-publication-on-the-potential-benefits-of-ampion-for-treatment-of-a-new-covid-19-related-syndrome-301095931.html

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  29. ENGLEWOOD, Colo., June 19, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE) (the "Company"), is a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions. As part of this program, the Company is developing therapies for patients infected with the SARS-CoV-2 virus ("COVID-19").

    The U.S. Food and Drug Administration ("FDA") completed its review of the Company's Investigative New Drug ("IND") application for intravenous ("IV") Ampion treatment for COVID-19 affected patients and has cleared the company to proceed with human trials.

    The Company will begin a Phase 1 clinical trial to evaluate IV Ampion as a treatment for COVID-19 patients on supplemental oxygen. The need for supplemental oxygen in COVID-19 patients is indicative of an inflammatory process in the lungs. As an immunomodulatory anti-inflammatory agent, Ampion may be effective in interrupting the inflammatory cascade associated with COVID-19 and improving the clinical course and outcome of patients.

    Years of extensive in-vitro studies on cell cultures have confirmed that the mechanism of action ("MOA") of Ampion may be suitable for the treatment of inflammatory conditions, such as acute respiratory distress syndrome ("ARDS") and the cytokine storm, associated with COVID-19. Many of these research related findings have been published in peer reviewed, scientific journals, which can be found on our website.

    About Ampio Pharmaceuticals

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032, and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward-Looking Statements                                                                   

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "may," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion™ and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, the timing and outcome of clinical trials, and that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Dan Stokely, CFO

    Phone: (720) 437-6500



    Ampio Pharmaceuticals, Inc.

    AMPE

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-to-start-first-clinical-trial-in-covid-19-program-301080033.html

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  30. ENGLEWOOD, Colo., May 22, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE) is a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions. As part of this program, the company is developing therapies for patients infected with the SARS-CoV-2 virus ("COVID-19").

    Ampio has filed Investigative New Drug ("IND") applications for Ampion™ with the FDA and has maintained ongoing dialog with the FDA regarding the Company's development of treatment options which includes inhalation and intravenous applications for COVID-19 affected patients.

    Years of extensive in-vitro studies on cell cultures have confirmed that the mechanism of action ("MOA") of Ampion may be suitable for the treatment of inflammatory conditions, such as acute respiratory distress syndrome ("ARDS") and the cytokine storm, associated with COVID-19. Many of these research related findings have been published in peer reviewed, scientific journals, which can be found on the Company's website.

    About Ampio Pharmaceutical

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward-Looking Statements                                                                                              

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact
    Dan Stokely, CFO
    Phone: (720) 437-6500
     
    Ampio Pharmaceuticals, Inc.
    AMPE

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-provides-update-on-covid-19-program-301064052.html

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  31. ENGLEWOOD, Colo., May 11, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the development of immunology based therapies for prevalent inflammatory conditions, today announced a manuscript accepted for publication in The Journal of Patient Safety in Surgery that showed Ampion treatment could improve clinical outcomes for COVID-19 patients.

    The manuscript titled, "The novel immunomodulatory biologic LMWF5A (Ampion) for pharmacological attenuation of the "cytokine storm" in COVID-19 patients: a hypothesis", provides a detailed description of the biochemical and immunological phenomena collectively termed the "cytokine storm" encountered in COVID-19 patients and evaluates the potential benefit of Ampion treatment for these patients. A link to the publication will be provided on the company's website once available.

    Ampio has submitted an Investigational New Drug ("IND") Application to the FDA for the use of nebulized Ampion to treat COVID-19 patients with acute respiratory distress syndrome ("ARDS") and is engaged in active discussions with the CBER division of the FDA with the goal to obtain permission to initiaite a U.S. clinical trial.

    About Ampio Pharmaceutical

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, AmpionTM, is backed by an extensive patent portfolio with intellectual property protection extending through 2032, and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward-Looking Statements                                                                                              

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," "potential," "improve," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, including, but not limited to, discussions with the FDA to open an IND for AmpionTM to treat COVID-19 patients with ARDS, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, that treatment with Ampion will improve clinical outcomes of certain COVID-19 patients, and decisions and changes in business conditions and similar events, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K, quarterly report of Form 10-Q and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact
    Dan Stokely, CFO
    Phone: (720) 437-6500

    Ampio Pharmaceuticals, Inc.
    AMPE

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-reports-acceptance-of-publication-on-the-potential-benefits-of-nebulized-ampion-for-covid-19-patients-301056319.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  32. ENGLEWOOD, Colo., April 2, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a pre-revenue development stage biopharmaceutical company focused on the development of immunology based therapies to treat prevalent inflammatory conditions announced today that it was featured on a FOX segment titled, "Englewood pharmaceutical company looking to treat COVID-19 patients with anti-inflammatory drug," reported by an affiliated television station in Denver, Colorado. The primary cause of death associated with SARS-Cov-2 ("COVID-19") infection is Acute Respiratory Distress Syndrome ("ARDS"), and there are no approved treatments for ARDS or COVID-19. The segment featured the Company's application to the FDA to study the treatment of COVID-19…

    ENGLEWOOD, Colo., April 2, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a pre-revenue development stage biopharmaceutical company focused on the development of immunology based therapies to treat prevalent inflammatory conditions announced today that it was featured on a FOX segment titled, "Englewood pharmaceutical company looking to treat COVID-19 patients with anti-inflammatory drug," reported by an affiliated television station in Denver, Colorado. The primary cause of death associated with SARS-Cov-2 ("COVID-19") infection is Acute Respiratory Distress Syndrome ("ARDS"), and there are no approved treatments for ARDS or COVID-19. The segment featured the Company's application to the FDA to study the treatment of COVID-19 induced ARDS with nebulized Ampion.

    To view the FOX video segment in its entirety please visit the link below. Additional information about the potential suitability of the anti-inflammatory properties of Ampion being used for this clinical indication (ARDS) is included in a companion white paper summary titled, "Rationale and scientific evidence for the use of Ampion in the treatment of Acute Respiratory Distress Syndrome secondary to SARS-COV-2," provided in the link below.

    Michael Macaluso, Ampio CEO, noted "The Company is exploring options that may enable the completion of the AP-013 study, our Phase 3 clinical trial for the treatment of severe osteoarthritis of the knee, during this COVID-19 pandemic. Simultaneously, we have directed our R&D efforts to explore the possible application of the immunomodulatory and anti-inflammatory properties of Ampion in the most severe and lethal complication of the COVID-19 infected patients: ARDS. The FDA has been very responsive, and the Company is grateful for the Agency's efforts as we work together to study the potential benefits of Ampion in this population."

    Enquiries from health professionals and media should be directed via email to  

    About Ampio Pharmaceuticals   

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032, and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act (BPCIA).

    Forward-Looking Statements 

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion™ and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application (BLA), the ability of Ampio to enter into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact
    Dan Stokely, CFO
    Phone: (720) 437-6500

     

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  33. ENGLEWOOD, Colo., March 24, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE, the ", Company", )), a pre-revenue development stage biopharmaceutical company announced today that it has suspended patient enrollment in its Phase 3 clinical trial of Ampion ("AP-013") for the treatment of severe osteoarthritis of the knee ("OAK"). The trial focuses on individuals with the most severely diseased OAK, which represents an underserved patient population typically excluded from clinical studies because of the intractable nature of their condition. The average and maximum age of a patient in the AP-013 clinical trial is 65 and 87 years old, respectively. The Centers for Disease Control and Prevention ("CDC") have indicated that older adults…

    ENGLEWOOD, Colo., March 24, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE, the ", Company", )), a pre-revenue development stage biopharmaceutical company announced today that it has suspended patient enrollment in its Phase 3 clinical trial of Ampion ("AP-013") for the treatment of severe osteoarthritis of the knee ("OAK"). The trial focuses on individuals with the most severely diseased OAK, which represents an underserved patient population typically excluded from clinical studies because of the intractable nature of their condition. The average and maximum age of a patient in the AP-013 clinical trial is 65 and 87 years old, respectively. The Centers for Disease Control and Prevention ("CDC") have indicated that older adults, 65 years and older, are at higher risk for severe illness during the current COVID-19 pandemic.

    The Safety Monitoring Committee ("SMC") for the AP-013 clinical trial has unanimously recommended, following an interim analysis and due to extenuating circumstances relating to the COVID-19 virus, to minimize risk to study participants that, "The study cease enrolling patients because the number of injected patients, 1,019, is sufficiently close to the number of patients called for by the sample size re-estimation algorithm, 1,034."

    The Federal Drug Administration ("FDA") has recognized that challenges may arise, for example, from quarantines, site closures, travel limitations, and/or other considerations due to the pandemic. The Contract Research Organization ("CRO") running the AP-013 clinical trial for the Company has notified the Company that due to the COVID-19 virus, all travel has been suspended for clinical study monitors, which severely limits our ability to monitor the conduct of the AP-013 clinical trial.  Recognizing these challenges, the Company is exploring options to enable it to complete the trial but notes that it is possible that the COVID-19 pandemic may prevent completion of the AP-013 trial at this time or at all.

    Concurrently, the Company is focusing on investigating the potential use of nebulized Ampion for the treatment of a serious complication of COVID-19, the rapid onset of respiratory failure, termed Acute Respiratory Distress Syndrome ("ARDS"). Based on Ampion's immunomodulatory and anti-inflammatory action, we believe that it may help individuals with widespread inflammation in the lungs and may reduce this serious complication of COVID-19.

    About Osteoarthritis
    Osteoarthritis ("OA") is an incurable and progressive disorder of the joint involving degradation of the intra-articular cartilage, joint lining, ligaments, and bone. Certain risk factors in conjunction with natural wear and tear lead to the breakdown of cartilage. OA is caused by inflammation of the soft tissue and bony structures of the joint, which worsens over time and leads to progressive thinning of articular cartilage. Other symptoms include narrowing of the joint space, synovial membrane thickening, osteophyte formation and increased density of subchondral bone.

    About Ampio Pharmaceuticals
    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead product candidate, AmpionTM, is backed by an extensive patent portfolio with intellectual property protection extending through 2032 and is eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward-Looking Statements
    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion™ and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact
    Daniel G. Stokely, CFO
    Phone: (720) 437-6500

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  34. ENGLEWOOD, Colo., March 24, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a pre-revenue development stage biopharmaceutical company focused on the development of immunology based therapies to treat prevalent inflammatory conditions for which limited treatment options exist, announced today that it is preparing an expanded access FDA protocol to study potential benefit of nebulized treatment with Ampion in SARS-Cov-2 ("COVID-19") induced Acute Respiratory Distress Syndrome ("ARDS"), an immediately life-threatening condition.

    Ampio's Scientific Advisory Board ("SAB") members David Bar-Or, MD, Pablo Rubinstein, MD, and Edward Brody, MD, PhD, determined after a careful review of the published articles on the properties of Ampion, that nebulized Ampion may be suitable to treat another inflammatory indication. Specifically, ARDS, one of the most dreaded complications of COVID-19 is associated with widespread inflammation in the lungs. The underlying mechanism of ARDS involves diffuse injury to cells which form the barrier of the microscopic air sacs (alveoli) of the lung, surfactant dysfunction, and activation of the immune system. The fluid accumulation in the lungs associated with ARDS is partially explained by vascular leakage due to inflammation. Ampion is an aqueous solution that may be delivered through nebulization and may be suitable for suppressing inflammation in the lungs.

    Ampion is a human blood derived composition, currently approved for clinical use by the FDA, as an anti-inflammatory, immunomodulating drug. The novel mode of action of Ampion involves multiple biochemical pathways associated with resolving inflammation1 which make it a potential therapy for ARDS as follows:

    • An important aspect of ARDS, triggered by COVID-19, is an initial release of chemical signals and other inflammatory mediators secreted by lung epithelial and endothelial cells. Neutrophils and some T-lymphocytes migrate into the inflamed lung tissue and contribute to the amplification/deterioration of ARDS. A decrease in the production of lipid mediators of inflammation (prostaglandins) may impair the resolution of inflammation associated with ARDS2,3. 

    • Ampion was reported to up regulate the production of these healing lipid mediators' prostaglandins in-vitro3. In addition, multiple inflammatory signals (i.e. TNF α, IL6, CXCL10) have been reported to be attenuated by Ampion, including a decrease in vascular permeability.

    • More than 1,000 patients with another inflammatory disease, osteoarthristis, have received Ampion without any serious drug related adverse events. A subset of these patients were given Ampion multiple times over the course of a year, and no serious drug related adverse events were observed.

    • Ampion is formulated as a sterile liquid and is easily administered as a nebulized liquid form. If Ampion is found to be an efficacious treatment for COVID-19 induced ARDS, the Company's in-house manufacturing facility may allow the product to be produced quickly and in significant quantities.

    The anticipated aim of a preliminary protocol for FDA review would be to evaluate patients with moderate to severe ARDS, triggered by COVID-19, for (1) reduced ventilator time; (2) reduction in mortality and (3) improvements in oxygenation parameters compared to non-Ampion treated patients.

    1 Bar-Or, et. al., On the Mechanisms of Action of the Low Molecular Weight Fraction of Commercial Human Serum Albumin in Osteoarthritis. Current Rheumatology Reviews, 2019, 15, 189-200.
    2 Fukunaga, et. al., Cyclooxygenase 2 Plays a Pivotal Role in the Resolution of Acute Lung Injury. Journal of Immunology 2005; 174:5033-5039.
    3  Gao et al. Resolvin D1 Improves the Resolution of Inflammation via Activating NF-κB p50/p50-Mediated Cyclooxygenase-2 Expression in Acute Respiratory Distress Syndrome, 174:5033-5039, J Immunol 2017

    About Ampio Pharmaceuticals          
    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead product candidate, AmpionTM,  is backed by an extensive patent portfolio with intellectual property protection extending through 2032 and is eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward-Looking Statements
    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," "may", and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion™ and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact
    Daniel G. Stokely, CFO
    Phone: (720) 437-6500

     

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  35. ENGLEWOOD, Colo., Feb. 21, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE) a development stage biopharmaceutical company, executing a Special Protocol Assessment ("SPA") Phase III clinical trial titled "Evaluating the Efficacy and Safety of Ampion to treat Adults with Pain Due to Severe Osteoarthritis of the Knee", today announced updates regarding the continued progress of its Phase III AP-013 clinical trial and receipt of its annual audit opinion. 

    Ampio Pharmaceuticals Logo.  (PRNewsFoto/Ampio Pharmaceuticals, Inc.) (PRNewsfoto/Ampio Pharmaceuticals, Inc.)

    Clinical Trial Update
    The AP-013 clinical trial is designed to evaluate the effect of Ampion on pain and function at 12-weeks in patients with severe osteoarthristis of the knee ("OAK"). This design would position Ampion as the first OAK therapy on the market to address pain and…

    ENGLEWOOD, Colo., Feb. 21, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE) a development stage biopharmaceutical company, executing a Special Protocol Assessment ("SPA") Phase III clinical trial titled "Evaluating the Efficacy and Safety of Ampion to treat Adults with Pain Due to Severe Osteoarthritis of the Knee", today announced updates regarding the continued progress of its Phase III AP-013 clinical trial and receipt of its annual audit opinion. 

    Ampio Pharmaceuticals Logo.  (PRNewsFoto/Ampio Pharmaceuticals, Inc.) (PRNewsfoto/Ampio Pharmaceuticals, Inc.)

    Clinical Trial Update
    The AP-013 clinical trial is designed to evaluate the effect of Ampion on pain and function at 12-weeks in patients with severe osteoarthristis of the knee ("OAK"). This design would position Ampion as the first OAK therapy on the market to address pain and function, and have a label and efficacy data for the severely diseased patient population, if approved. As of February 14, 2020 the following had occurred:

    • Of the 1,034 patients to be enrolled in AP-013, 875 patients have been dosed with enrollment continuing to progress. Exclusions for participation in the trial average approximately 35% in order to ensure enrollment of only patients with severe osteoarthritis of the knee who do not have other pain or medical conditions that could interfere with their assessment of the pain and function in the injected knee.
    • More than 600 patients have reached the study's 12-week primary endpoint, making the clinical trial more than 58% complete for the primary endpoint.

    Receipt of Audit Opinion with Going Concern Qualification
    The Company is required under the NYSE American Company Guidelines Sections 401(h) and 610(b) to publish certain disclosures.  As previously disclosed within its Annual Report on Form 10-K for the fiscal year ended December 31, 2019, which was filed with the Securities and Exchange Commission on February 21, 2020, the Company's audited financial statements contained a going concern explanatory paragraph in the audit opinion from its independent registered public accounting firm.  This announcement does not represent any change or amendment to the Company's financial statements or to its Annual Report on Form 10-K for the fiscal year ended December 31, 2019.  A copy of the Company's Form 10-K is located on the Company's website at www.ampiopharma.com/investors/financial-filings.  Shareholders also have the ability to receive a hard copy of the Company's Form 10-K free of charge upon request.

    About Special Protocol Assessment
    A SPA is a process in which sponsors may ask to meet with the FDA to reach an agreement on the design and size of certain clinical trials to determine if they adequately address scientific and regulatory requirements for a study that could support marketing approval. Our SPA agreement for the above referenced study indicates concurrence by the FDA with the adequacy and acceptability of specific critical elements of overall protocol design for the study, which we intend to support a future Biologic License Application ("BLA").

    About Osteoarthritis
    Osteoarthritis ("OA") is an incurable and progressive disorder of the joints involving degradation of the intra-articular cartilage, joint lining, ligaments, and bone. Certain risk factors in conjunction with natural wear and tear lead to the breakdown of cartilage. OA is caused by inflammation of the soft tissue and bony structures of the joint, which worsens over time and leads to progressive thinning of articular cartilage. Other symptoms include narrowing of the joint space, synovial membrane thickening, osteophyte formation and increased density of subchondral bone.

    About Ampio Pharmaceuticals
    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward-Looking Statements
    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion™ and its classification, as well as those associated with regulatory approvals and other FDA decisions, the BLA, the ability of Ampio to enter into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact
    Daniel G. Stokely, CFO
    Phone: (720) 437-6500

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  36. ENGLEWOOD, Colo., Dec. 4, 2019 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE) a development stage biopharmaceutical company, executing a Special Protocol Assessment (SPA) Phase III clinical trial titled  "Evaluating the Efficacy and Safety of Ampion™ to treat Adults with Pain Due to Severe Osteoarthritis of the Knee", today announced updates regarding the continued progress of its Phase III AP-013 clinical trial and its manufacturing facility. 

    Ampio Pharmaceuticals Logo.  (PRNewsFoto/Ampio Pharmaceuticals, Inc.) (PRNewsfoto/Ampio Pharmaceuticals, Inc.)

    Clinical Trial Update: 
    Ampio's COO, Holli Cherevka, summarized: 

    • "As of December 3, 2019, of the 1,034 patients to be enrolled in AP-013, more than 700 have been injected and an additional 50 patients have been approved for injection in the near term. As more than 350 patients have now reached

    ENGLEWOOD, Colo., Dec. 4, 2019 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE) a development stage biopharmaceutical company, executing a Special Protocol Assessment (SPA) Phase III clinical trial titled  "Evaluating the Efficacy and Safety of Ampion™ to treat Adults with Pain Due to Severe Osteoarthritis of the Knee", today announced updates regarding the continued progress of its Phase III AP-013 clinical trial and its manufacturing facility. 

    Ampio Pharmaceuticals Logo.  (PRNewsFoto/Ampio Pharmaceuticals, Inc.) (PRNewsfoto/Ampio Pharmaceuticals, Inc.)

    Clinical Trial Update: 
    Ampio's COO, Holli Cherevka, summarized: 

    • "As of December 3, 2019, of the 1,034 patients to be enrolled in AP-013, more than 700 have been injected and an additional 50 patients have been approved for injection in the near term. As more than 350 patients have now reached the study's 12-week primary endpoint, the clinical trial is more than 33% complete. Exclusions from the more than 1,050 consented patients continues to average 29% in order to ensure enrollment of only patients with severe osteoarthritis of the knee who do not have other pain or medical conditions that could interfere with their assessment of the pain and function in the injected knee."

    • "On October 22, 2019, the independent Safety Monitoring Committee completed a confidential review of the results from the first 300 randomized subjects.  As a result of the review, the current safety profiles of Ampion and the placebo injections are similar, and to date, study investigators have identified no remarkable safety findings. These results are consistent with the safety profile observed in over 2,000 patients in the Ampion clinical development."

     Manufacturing Facility Update:

    • Ampio has built a compact, highly efficient and cost-effective, GMP manufacturing facility at our corporate headquarters to enable the Company to have direct oversite and control over the ongoing manufacturing and commercial launch of Ampion shortly after FDA approval of Ampion. This facility utilizes sterile, single-use processing disposables in an automated, proprietary process that creates a market advantage with flexible pricing, strong operating margins and capacity to meet global demand.
    • All CMC validation lots for BLA submission have been completed and documented.
    • Approximately 200,000 Ampion vials have been filled without contamination.
    • The "ball room" platform technology used in the facility is flexible and supports the possible expansion of indications by providing filling of IV bags and syringes as well as vials.
    • Based on observed production rates, the Company believes that three-shift annual capacity of this facility would be ~ 8,000,000 vials at very low direct product cost and strong operating margins.
    • The Company engaged RMC Pharma ( http://www.rmcpharma.com/ ) an independent third-party regulatory consulting firm to conduct a comprehensive audit over multiple days while the Company was conducting CMC manufacturing runs. The audit results reflected no serious negative findings and RMC concluded the facility is ready for FDA audit.

    Ampio Annual Meeting & Broadcast: 
    On Saturday, December 14, 2019 at 9:00 AM MT, Ampio will be holding their annual meeting, which will be accessible to all investors calling in at:
    U.S./Canada toll-free number: 877-901-1999
    U.S. Local number: +1 267-930-4000
    Participant Passcode: 853-458-357

    Additional updates, if any, regarding the AP-013 Phase III Clinical trial may be discussed at this meeting

    An audio replay of this Annual Meeting will be posted on Ampio's website within 24 hours. Link at https://ampiopharma.com/investors/presentations-media/

    About Special Protocol Assessment (SPA)
    A SPA is a process in which sponsors may ask to meet with the FDA to reach an agreement on the design and size of certain clinical trials to determine if they adequately address scientific and regulatory requirements for a study that could support marketing approval. Our SPA agreement for the above referenced study indicates concurrence by the FDA with the adequacy and acceptability of specific critical elements of overall protocol design for the study, which we intend to support a future Biologic License Application (BLA).

    About Osteoarthritis
    Osteoarthritis (OA) is an incurable and progressive disorder of the joints involving degradation of the intra-articular cartilage, joint lining, ligaments, and bone. Certain risk factors in conjunction with natural wear and tear lead to the breakdown of cartilage. OA is caused by inflammation of the soft tissue and bony structures of the joint, which worsens over time and leads to progressive thinning of articular cartilage. Other symptoms include narrowing of the joint space, synovial membrane thickening, osteophyte formation and increased density of subchondral bone.

    About Ampio Pharmaceuticals
    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion™,  is backed by an extensive patent portfolio with intellectual property protection extending through 2032 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act (BPCIA).

    Forward-Looking Statements
    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion™ and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application (BLA), the ability of Ampio to enter into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact
    Daniel G. Stokely, CFO
    Phone: (720) 437-6500

     

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  37. ENGLEWOOD, Colo., Oct. 10, 2019 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE) a development stage biopharmaceutical company, executing a Special Protocol Assessment (SPA) Phase III clinical trial titled "Evaluating the Efficacy and Safety of AmpionTM to treat Adults with Pain Due to Severe Osteoarthritis of the Knee," today announced updates of the continued progress with their Phase III AP-013 clinical trial and their "state-of-the-Art" manufacturing facility.

    Ampio Pharmaceuticals Logo.  (PRNewsFoto/Ampio Pharmaceuticals, Inc.) (PRNewsfoto/Ampio Pharmaceuticals, Inc.)

    Progress Update on AP-013 Clinical Trial:
    Ampio's COO, Holli Cherevka, noted that "Ampio is now enrolling patients at 23 of the 25 clinical sites authorized by the FDA and, as of October 8th, of the 1,034 patients to be enrolled in AP-013, 510 have been injected and an additional

    ENGLEWOOD, Colo., Oct. 10, 2019 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE) a development stage biopharmaceutical company, executing a Special Protocol Assessment (SPA) Phase III clinical trial titled "Evaluating the Efficacy and Safety of AmpionTM to treat Adults with Pain Due to Severe Osteoarthritis of the Knee," today announced updates of the continued progress with their Phase III AP-013 clinical trial and their "state-of-the-Art" manufacturing facility.

    Ampio Pharmaceuticals Logo.  (PRNewsFoto/Ampio Pharmaceuticals, Inc.) (PRNewsfoto/Ampio Pharmaceuticals, Inc.)

    Progress Update on AP-013 Clinical Trial:
    Ampio's COO, Holli Cherevka, noted that "Ampio is now enrolling patients at 23 of the 25 clinical sites authorized by the FDA and, as of October 8th, of the 1,034 patients to be enrolled in AP-013, 510 have been injected and an additional 63 are currently in the screening."

    "It is important to note," Ms. Cherevka continued, "in the three randomized single-injection studies previously run by the Company, both reduction in pain and improvement in function were significantly greater for KL 4 patients treated with Ampion vs saline. These results imply that had there been increased patient enrollment, the p-values in each case would have demonstrated a statistically significant clinical benefit with the treatment utilizing Ampion compared to saline. The Company believes the FDA approved SPA trial design supporting the current AP-013 study addresses this issue by allowing > 1,000 KL 4 patients to be dosed. In fact, the combined results of the prior single injection trials showed twice the necessary efficacy for both pain and function to be statistically significant in AP-013 (p-value < 0.05)."

    Progress Update of Ampion Manufacturing facility:
    Ampio's CEO, Michael Macaluso, acknowledged that it was unusual for a development stage biopharmaceutical company the size of Ampio to have constructed a GMP turnkey manufacturing facility capable of supplying global demand for its lead product, and further explained the rationale: "Since Dr. David Bar-Or was able to develop a process by which Ampion is extracted through utilization of a proprietary filtration process of the FDA Licensed blood product, Human Serum Albumin (HSA), and the Company was confident of the efficacy of the drug, we determined it would be prudent to build a compact (~3300 sq.ft.), highly efficient and cost-effective, GMP manufacturing facility in our corporate headquarters. Importantly, we believe this will enable the Company to have direct oversite and control over the ongoing manufacturing and commercial launch of Ampion shortly after FDA approval of Ampion. Furthermore, our facility utilizes sterile, single-use processing disposables in an automated, proprietary process that creates what we believe is a market advantage with flexible pricing, strong operating margins and the capacity to meet global demand. My confidence that our manufacturing facility will meet both short and long term demand, should Ampion receive FDA approval, is supported by the following:

    • All the required FDA CMC manufacturing pilot lots have been completed and documented.
    • Approximately 200,000 Ampion vials have been filled without contamination.
    • The "ball room" platform technology used in the facility is flexible and supports possible expansion of indications by providing filling of IV bags and syringes as well as vials.
    • Based on observed production rates, the three-shift annual capacity of this facility would be ~ 8,000,000 vials at very low direct product cost and strong operating margins.
    • The Company engaged RMC Pharma (http://www.rmcpharma.com/) an independent third-party regulatory consulting firm to conduct a comprehensive audit over multiple days while the Company was conducting CMC manufacturing runs. The audit results reflected no serious negative findings and RMC concluded in their opinion the facility is ready for FDA audit.
    • The Company has secured long term HSA supply agreements."

    About Special Protocol Assessment (SPA)
    A SPA is a process in which sponsors may ask to meet with the FDA to reach agreement on the design and size of certain clinical trials to determine if they adequately address scientific and regulatory requirements for a study that could support marketing approval. Our SPA agreement for the above referenced study indicates concurrence by the FDA with the adequacy and acceptability of specific critical elements of overall protocol design for the study, which we intend to support a future Biologic License Application (BLA).

    About Osteoarthritis
    Osteoarthritis (OA) is an incurable and progressive disorder of the joints involving degradation of the intra-articular cartilage, joint lining, ligaments, and bone. Certain risk factors in conjunction with natural wear and tear lead to the breakdown of cartilage. OA is caused by inflammation of the soft tissue and bony structures of the joint, which worsens over time and leads to progressive thinning of articular cartilage. Other symptoms include narrowing of the joint space, synovial membrane thickening, osteophyte formation and increased density of subchondral bone.

    About Ampio Pharmaceuticals
    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032 and may be eligible for 12-year FDA market exclusivity if approved as a novel biologic under the biologics price competition and innovation act (BPCIA).

    Forward-Looking Statements
    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," "would have" and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion™ and its classification, as well as those associated with pending regulatory approvals and other FDA decisions, the Biological License Application (BLA), the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact
    Dan Stokely, CFO
    Phone: (720) 437-6500

     

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  38. ENGLEWOOD, Colo., Sept. 18, 2019 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE) a development stage biopharmaceutical company, executing a Special Protocol Assessment (SPA) phase three clinical trial titled  "Evaluating the Efficacy and Safety of Ampion to treat Adults with Pain Due to Severe Osteoarthritis of the Knee", today announced that Cooley LLP has been engaged to represent Ampio with respect to a potential strategic transaction, as well as related matters. Jeff Libson, a partner at Cooley, will lead the Cooley team and will provide legal advice to the newly formed Transaction Advisory Committee (TAC) and Ampio's Board of Directors. 

    Ampio Pharmaceuticals Logo.  (PRNewsFoto/Ampio Pharmaceuticals, Inc.) (PRNewsfoto/Ampio Pharmaceuticals, Inc.)

    Mr. Libson has practiced law for 35+ years and is widely regarded as one of the leading…

    ENGLEWOOD, Colo., Sept. 18, 2019 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE) a development stage biopharmaceutical company, executing a Special Protocol Assessment (SPA) phase three clinical trial titled  "Evaluating the Efficacy and Safety of Ampion to treat Adults with Pain Due to Severe Osteoarthritis of the Knee", today announced that Cooley LLP has been engaged to represent Ampio with respect to a potential strategic transaction, as well as related matters. Jeff Libson, a partner at Cooley, will lead the Cooley team and will provide legal advice to the newly formed Transaction Advisory Committee (TAC) and Ampio's Board of Directors. 

    Ampio Pharmaceuticals Logo.  (PRNewsFoto/Ampio Pharmaceuticals, Inc.) (PRNewsfoto/Ampio Pharmaceuticals, Inc.)

    Mr. Libson has practiced law for 35+ years and is widely regarded as one of the leading life sciences practitioners in the eastern United States. In addition to practicing law, he is an adjunct professor at The Wharton School of the University of Pennsylvania where he teaches a graduate business course in life sciences/health care entrepreneurship.  His focus at Cooley is representing life sciences companies in business matters, including governance, M&A, strategic transactions and financings where he has advised buyers, sellers and investors in numerous acquisition, disposition and combination transactions involving both public and private companies across the biotech and pharmaceutical sectors.

    Michael Macaluso, Ampio CEO, noted, "With Jeff and his team providing legal advice regarding possible strategic transactions to our TAC  and the Board of Directors, we are satisfied that we have assembled a group that possesses the experience and expertise necessary to provide comprehensive evaluations of our strategic options in a rapidly evolving healthcare market place."

    About Transaction Advisory Committee members

    William Bindley 
    Mr Bindley is Chairman of Bindley Capital Partners, LLC, a private equity investment firm headquartered in Indianapolis, Indiana and is also a Founder and current Chairman of Guardian Pharmacy Services, the largest privately held long term care pharmacy in the United States. Mr. Bindley also founded, and was Chairman of Priority Healthcare Corporation, a national provider of bio-pharmaceuticals and complex therapies for chronic disease states with annual revenues of over $2 Billion when it was sold to Express Scripts in 2005. Mr. Bindley was the Chairman, President, Chief Executive Officer and founder of Bindley Western Industries, Inc., a national pharmaceutical distributor and nuclear pharmacy operator that was a NYSE Fortune 200 company at the time of its merger into Cardinal Health, Inc. in 2001. He previously served on the boards of Cardinal Health, Inc., Key Bank, NA, Bindley Western Industries, Priority Healthcare Corporation, and Shoe Carnival, Inc. He received both a B.S. degree in Industrial Economics and a Doctor of Management (H.C.) degree from Purdue University. He also completed the Wholesale Management Program at the Graduate School of Business at Stanford University. He is the past Vice Chairman of the United States Ski and Snowboard Association and serves on the President's Advisory Council at Purdue University. Mr. Bindley provided funding for the construction of the Bindley Bioscience Center which was part of the largest gift by an individual in Purdue University history. Mr Bindley was also an owner of the Indian Pacers Professional Basketball Team.

    Bruce E. Terker
    Mr. Terker is a Founding Partner of a number of private equity and alternative asset management firms which include Odyssey Capital Group, Ballyshannon Partners and Argosy Capital.  Mr. Terker is on the advisory board of The Rodney L White Center for Financial Research at the Wharton School at the University of Pennsylvania, as well as the founder and benefactor of the Marshall Blume Prizes in Investment Research.  Mr. Terker was a co‑founder and Partner in Geewax, Terker and Company, a registered investment advisor that managed over $8 billion and which catered to the institutional investor marketplace for over 25 years.  He has extensive experience investing in the Life Sciences and Biopharmaceutical Industries.  Mr. Terker previously taught courses in Investments and Corporate Finance at the Wharton School, and has been published in the Journal of Finance for his research in capital market theory and asset pricing. 

    About Special Protocol Assessment (SPA)
    A SPA is a process in which sponsors may ask to meet with the FDA to reach agreement on the design and size of certain clinical trials to determine if they adequately address scientific and regulatory requirements for a study that could support marketing approval. Our SPA agreement for the above referenced study indicates concurrence by the FDA with the adequacy and acceptability of specific critical elements of overall protocol design for the study, which we intend to support a future Biologic License Application (BLA).

    About Osteoarthritis
    Osteoarthritis (OA) is an incurable and progressive disorder of the joints involving degradation of the intra-articular cartilage, joint lining, ligaments, and bone. Certain risk factors in conjunction with natural wear and tear lead to the breakdown of cartilage. OA is caused by inflammation of the soft tissue and bony structures of the joint, which worsens over time and leads to progressive thinning of articular cartilage. Other symptoms include narrowing of the joint space, synovial membrane thickening, osteophyte formation and increased density of subchondral bone.

    About Ampio Pharmaceuticals
    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the develop- ment of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. 

    Forward-Looking Statements
    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion™ and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application (BLA), the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact
    Dan Stokely, CFO
    Phone: (720) 437-6500

     

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  39. ENGLEWOOD, Colo., Sept. 17, 2019 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE) today announced the progress to date in the Company's special protocol assessment (SPA) phase three clinical trial titled, "A Randomized, Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of an Intra-Articular Injection of Ampion in Adults with Pain Due to Severe Osteoarthritis of the Knee."

    Ampio Pharmaceuticals Logo.  (PRNewsFoto/Ampio Pharmaceuticals, Inc.) (PRNewsfoto/Ampio Pharmaceuticals, Inc.)

    According to Holli Cherevka, Ampio COO, "We are pleased with the progress we have made to date, and the recent FDA agreement to expand the number of clinical sites in this pivotal study. The FDA has given written guidance that prior study AP-003-A qualifies as a pivotal trial, and that successfully passing the current study, AP-013, would support

    ENGLEWOOD, Colo., Sept. 17, 2019 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE) today announced the progress to date in the Company's special protocol assessment (SPA) phase three clinical trial titled, "A Randomized, Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of an Intra-Articular Injection of Ampion in Adults with Pain Due to Severe Osteoarthritis of the Knee."

    Ampio Pharmaceuticals Logo.  (PRNewsFoto/Ampio Pharmaceuticals, Inc.) (PRNewsfoto/Ampio Pharmaceuticals, Inc.)

    According to Holli Cherevka, Ampio COO, "We are pleased with the progress we have made to date, and the recent FDA agreement to expand the number of clinical sites in this pivotal study. The FDA has given written guidance that prior study AP-003-A qualifies as a pivotal trial, and that successfully passing the current study, AP-013, would support the filing of our BLA."

    • As of September 16th we have consented/enrolled 661 patients of which 423 have been injected and an additional 52 of these patients have been approved for injection, which should take place shortly. 
    • 186 of the consented patients did not meet our inclusion/exclusion criteria (~28% of the consented) and will not be participating in the trial. This criteria was established to ensure that the 1,034 KL 4 patients dosed in this trial were very closely similar in age, sex, and severity of disease to the 417 KL 4 patients in our previous single-injection trials that, cumulatively, experienced a statistically significant reduction in pain and improvement in function from Ampion compared to the saline control.
    • FDA has authorized the use of 8 additional clinical sites, which will be operational by the end of September and will bring the total number of active sites to 25.

    "It is important to note," Ms. Cherevka explained, "that in the three randomized single-injection studies previously run by the Company, both reduction in pain and improvement in function were greater with Ampion-treated KL 4 patients than saline treated KL 4 patients. These results imply that had there been increased patient enrollment, the p-values in each case would have demonstrated a statistically significant clinical benefit with Ampion treatment compared to saline. The Company believes the FDA-agreed SPA trial design of the current AP-013 study addresses this issue by allowing > 1,000 KL 4 patients to be dosed.  In fact, the combined results of the prior single-injection trials indicate that the AP-013 KL 4 patients could report a difference of Ampion over saline that is 50% less than observed in the prior trials, and the clinical benefit of Ampion in both pain and function would still be statistically significant (p-value < 0.05)." 

    About Special Protocol Assessment (SPA)
    A SPA is a process in which sponsors may ask to meet with the FDA to reach agreement on the design and size of certain clinical trials to determine if they adequately address scientific and regulatory requirements for a study that could support marketing approval. Our SPA agreement for the above referenced study indicates concurrence by the FDA with the adequacy and acceptability of specific critical elements of overall protocol design for the study, which we intend to support a future Biologic License Application (BLA).

    About Osteoarthritis
    Osteoarthritis (OA) is an incurable and progressive disorder of the joints involving degradation of the intra-articular cartilage, joint lining, ligaments, and bone. Certain risk factors in conjunction with natural wear and tear lead to the breakdown of cartilage. OA is caused by inflammation of the soft tissue and bony structures of the joint, which worsens over time and leads to progressive thinning of articular cartilage. Other symptoms include narrowing of the joint space, synovial membrane thickening, osteophyte formation and increased density of subchondral bone.

    About Ampio Pharmaceuticals 
    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. 

    Forward-Looking Statements 
    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion™ and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application (BLA), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact
    Dan Stokely, CFO
    Phone: (720) 437-6500

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-pharmaceuticals-updates-progress-of-spa-clinical-trial-300919369.html

    SOURCE Ampio Pharmaceuticals, Inc.

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