EARS

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Upcoming Catalysts

Drug Stage Catalyst Date
AM-125 (TRAVERS)
Vertigo
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Keyzilen (AM-101) - TACTT2
Acute inner ear tinnitus
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoints
AM-301
Allergic rhinitis
Phase 1
Phase 1
510(k) pre-market notification application to be filed.
AM-201
Healthy volunteers
Phase 1b
Phase 1b
Phase 1b data released May 26, 2020. Phase 2 trial planned.
Keyzilen (AM-101)
Acute inner ear tinnitus
Phase 3
Phase 3
Phase 3 data released March 13, 2018 - primary endpoint not met. Noted April 25, 2019 that it intends to discuss a new Phase 2/3 trial with the FDA.
AM-111 ASSENT
Acute inner ear hearing loss
Phase 3
Phase 3
Phase 3 ASSENT trial terminated - November 28, 2017.
AM-111 HEALOS
Acute inner ear hearing loss
Phase 3
Phase 3
Phase 3 HEALOS trial did not meet primary endpoint - November 28, 2017.

Latest News

  1. Hamilton, Bermuda, July 15, 2021 – Auris Medical Holding Ltd. (NASDAQ:EARS), a company dedicated to addressing unmet medical needs through RNA therapeutics, allergy and viral infection protection, and inner ear therapeutics, today announced the launch of its newly-designed corporate website www.aurismedical.com. The new website features a streamlined and modern design and also reflects the Company's recently announced strategic repositioning.

    "We are proud to present our projects and products as well as the science behind them through a completely redesigned website", commented Thomas Meyer, Auris Medical's founder, Chairman and CEO. "Importantly, the new website reflects the Company's recent strategic move into RNA therapeutics, while highlighting…

    Hamilton, Bermuda, July 15, 2021 – Auris Medical Holding Ltd. (NASDAQ:EARS), a company dedicated to addressing unmet medical needs through RNA therapeutics, allergy and viral infection protection, and inner ear therapeutics, today announced the launch of its newly-designed corporate website www.aurismedical.com. The new website features a streamlined and modern design and also reflects the Company's recently announced strategic repositioning.

    "We are proud to present our projects and products as well as the science behind them through a completely redesigned website", commented Thomas Meyer, Auris Medical's founder, Chairman and CEO. "Importantly, the new website reflects the Company's recent strategic move into RNA therapeutics, while highlighting the exciting prospects for its traditional businesses." As recently announced, Auris Medical is planning to change its name to Altamira Therapeutics, subject to approval by a special general meeting of shareholders on July 21, 2021, and to divest or spin off its traditional businesses in respiratory and inner ear therapeutics with the aim of unlocking shareholder value.

    About Auris Medical

    Auris Medical is dedicated to developing therapeutics that address important unmet medical needs. The Company is currently active in three areas: the development of RNA therapeutics for extrahepatic therapeutic targets (OligoPhore™ / SemaPhore™ platforms; preclinical), nasal sprays for protection against airborne viruses and allergens (Bentrio™; commercial) or the treatment of vertigo (AM-125; Phase 2), and the development of therapeutics for intratympanic treatment of tinnitus or hearing loss (Keyzilen® and Sonsuvi®, Phase 3). The Company was founded in 2003 and is headquartered in Hamilton, Bermuda with its main operations in Basel, Switzerland. The shares of Auris Medical Holding Ltd. trade on the NASDAQ Capital Market under the symbol "EARS." The Company will change its name to "Altamira Therapeutics Ltd." and its ticker symbol to "CYTO", subject to approval by a Special General Meeting of shareholders to be held on July 21, 2021.

    Forward-looking Statements

    This press release may contain statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or Auris Medical's strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may", "might", "will", "should", "expects", "plans", "anticipates", "believes", "estimates", "predicts", "projects", "potential", "outlook" or "continue", or the negative of these terms or other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the approval and timing of commercialization of AM-301, Auris Medical's need for and ability to raise substantial additional funding to continue the development of its product candidates, the timing and conduct of clinical trials of Auris Medical's product candidates, the clinical utility of Auris Medical's product candidates, the timing or likelihood of regulatory filings and approvals, Auris Medical's intellectual property position and Auris Medical's financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Auris Medical's capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption "Risk Factors" in Auris Medical's Annual Report on Form 20-F for the year ended December 31, 2020, and in Auris Medical's other filings with the SEC, which are available free of charge on the Securities Exchange Commission's website at: www.sec.gov. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated. All forward-looking statements and all subsequent written and oral forward-looking statements attributable to Auris Medical or to persons acting on behalf of Auris Medical are expressly qualified in their entirety by reference to these risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and Auris Medical does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law.

    Investor contact:



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    • Bentrio™ formulation well tolerated in vitro on human nasal epithelium
    • Up to 99% reduction of SARS-CoV-2 viral titer with prophylactic treatment vs. controls
    • Viral titer reduced 12- or 14-fold vs. controls when treatment started 24 or 30 h post infection

    Hamilton, Bermuda, July 14, 2021 – Auris Medical Holding Ltd. (NASDAQ:EARS), a company dedicated to addressing unmet medical needs through RNA therapeutics, allergy and viral infection protection, and inner ear therapeutics, today announced additional preclinical data in a model of primary human nasal airway epithelium from its Bentrio™ (AM-301) nasal spray development program in SARS-CoV-2. AM-301 was found to be safe in vitro, and it significantly decelerated viral titer growth in experimental…



    • Bentrio™ formulation well tolerated in vitro on human nasal epithelium

    • Up to 99% reduction of SARS-CoV-2 viral titer with prophylactic treatment vs. controls
    • Viral titer reduced 12- or 14-fold vs. controls when treatment started 24 or 30 h post infection

    Hamilton, Bermuda, July 14, 2021 – Auris Medical Holding Ltd. (NASDAQ:EARS), a company dedicated to addressing unmet medical needs through RNA therapeutics, allergy and viral infection protection, and inner ear therapeutics, today announced additional preclinical data in a model of primary human nasal airway epithelium from its Bentrio™ (AM-301) nasal spray development program in SARS-CoV-2. AM-301 was found to be safe in vitro, and it significantly decelerated viral titer growth in experimental models of prophylaxis and mitigation. The manuscript describing these preclinical data is available on a preprint server at https://www.biorxiv.org/content/10.1101/2021.07.12.452021v1 and will undergo scientific peer-review for potential publication.

    "These data provide strong evidence for Bentrio's potential to help reduce the risk of SARS-CoV-2 infection of human mucosal cells when used preventatively and to decelerate its course when used shortly after its onset", commented Thomas Meyer, Auris Medical's founder, Chairman and CEO. "Recently published clinical data from an independent research group show that targeting the nasal mucosa during the early stage of Covid-19 is an ideal strategy for preventing the propagation of SARS-CoV-2.1 We look forward to the imminent start of the market roll-out of our Bentrio nasal spray to help address this current pandemic with a novel drug-free means for self-protection."

    The preclinical studies were performed in a well-established model of reconstituted nasal epithelium from human donors (MucilAir™), which provides testing conditions that tend to be more challenging than real-life conditions in the human nose. AM-301 was studied to determine its compatibility with MucilAir™, its efficacy in preventing MucilAir™ from being infected by SARS-CoV-2, and its ability to mitigate an established infection in MucilAir™ without any previous treatment. First, AM-301 had no detrimental effects on MucilAir™ inserts despite repeated application over 4 days: measures of tight junction integrity and cytotoxicity support Bentrio's safety and did not show any significant difference between treated and control cultures. An expected finding was that the ciliary beat frequency was slightly reduced due to the viscosity of the formulation.

    Prophylactic treatment with AM-301 was protective against SARS-CoV-2 infection, as daily application of the product starting 10 minutes prior to inoculation led to a 2-log (99%) reduction in viral titer (Tissue Culture Infectious Dose; TCID50) by Day 4 compared to controls. Inserts that received the product daily, starting 24 or 30 h after viral infection, also had a lower viral titer, corresponding to a 12- or 14-fold lower TCID50 at the end of the treatment. In a linear-effects mixed model with log-transformed data, the time profile of SARS-CoV-2 infection was significantly decelerated compared to controls both in case of prophylactic treatment (t=5.49; p<0.001) and in case of mitigation treatment starting 24 or 30 h post infection (t=3.68; p<0.01).

    As recently announced, Auris Medical's affiliate Altamira Medica Ltd. will start the market roll-out of Bentrio™ by launching it in Germany. Bentrio™ will shortly become available through selected online pharmacies; over the coming months, market coverage will be expanded progressively through additional distribution channels and in further countries.

    About Bentrio

    Bentrio™ (AM-301) is a drug-free nasal spray for personal protection against airborne viruses and allergens. Upon application into the nose, Bentrio™ forms a protective gel layer on the nasal mucosa. This thin film is designed to prevent the contact of viruses or allergens with cells; in addition, the composition serves to bind such particles and help with their discharge and to humidify the nasal mucosa. Together, this is designed to reduce the risk of upper respiratory tract viral infections and promote alleviation of allergic symptoms. In human nasal epithelium cells infected by SARS-CoV-2, Bentrio™ was shown to reduce the infectious viral load by more than 99% when used for prevention. Further, Bentrio™ was effective in slowing the growth of the viral titer when treatment started only 24 or 30 hours after infection. In allergy, a clinical investigation in a pollen challenge chamber demonstrated a significant reduction in the main symptoms of allergic rhinitis with the protective effect setting in rapidly and lasting for 4 hours.

    About Auris Medical

    Auris Medical is dedicated to developing therapeutics that address important unmet medical needs. The Company is currently active in three areas: the development of RNA therapeutics for extrahepatic therapeutic targets (OligoPhore™ / SemaPhore™ platforms; preclinical), nasal sprays for protection against airborne viruses and allergens (Bentrio™; pre-commercial) or the treatment of vertigo (AM-125; Phase 2), and the development of therapeutics for intratympanic treatment of tinnitus or hearing loss (Keyzilen® and Sonsuvi®, Phase 3). The Company was founded in 2003 and is headquartered in Hamilton, Bermuda with its main operations in Basel, Switzerland. The shares of Auris Medical Holding Ltd. trade on the NASDAQ Capital Market under the symbol "EARS." The Company will change its name to "Altamira Therapeutics Ltd." and its ticker symbol to "CYTO", subject to approval by a Special General Meeting of shareholders to be held on July 21, 2021.

    Forward-looking Statements

    This press release may contain statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or Auris Medical's strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may", "might", "will", "should", "expects", "plans", "anticipates", "believes", "estimates", "predicts", "projects", "potential", "outlook" or "continue", or the negative of these terms or other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the approval and timing of commercialization of AM-301, Auris Medical's need for and ability to raise substantial additional funding to continue the development of its product candidates, the timing and conduct of clinical trials of Auris Medical's product candidates, the clinical utility of Auris Medical's product candidates, the timing or likelihood of regulatory filings and approvals, Auris Medical's intellectual property position and Auris Medical's financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Auris Medical's capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption "Risk Factors" in Auris Medical's Annual Report on Form 20-F for the year ended December 31, 2020, and in Auris Medical's other filings with the SEC, which are available free of charge on the Securities Exchange Commission's website at: www.sec.gov. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated. All forward-looking statements and all subsequent written and oral forward-looking statements attributable to Auris Medical or to persons acting on behalf of Auris Medical are expressly qualified in their entirety by reference to these risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and Auris Medical does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law.

    Investor contact:

         


    1 Ahn JH et al. (2021), Nasal ciliated cells are primary targets for SARS-CoV-2 replication in the early stage of COVID-19, J Clin Invest. 131(13):e148517.



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    • Treatment of KRAS-driven colorectal cancer selected as first therapeutic indication for OligoPhore™ platform
    • Company to launch development program under project code AM-401 with aim of IND submission in late 2022

    Hamilton, Bermuda, July 6, 2021 – Auris Medical Holding Ltd. (NASDAQ:EARS), a company dedicated to addressing unmet medical needs through RNA therapeutics, allergy and viral infection protection, and inner ear therapeutics, today announced the selection of mutant KRAS-driven colorectal cancer as the first therapeutic indication for its OligoPhore™ oligonucleotide delivery platform. The Company intends to develop the treatment under project code AM-401 with submission of an IND targeted for the end of 2022.

    Addressing high unmet medical

    • Treatment of KRAS-driven colorectal cancer selected as first therapeutic indication for OligoPhore™ platform
    • Company to launch development program under project code AM-401 with aim of IND submission in late 2022

    Hamilton, Bermuda, July 6, 2021 – Auris Medical Holding Ltd. (NASDAQ:EARS), a company dedicated to addressing unmet medical needs through RNA therapeutics, allergy and viral infection protection, and inner ear therapeutics, today announced the selection of mutant KRAS-driven colorectal cancer as the first therapeutic indication for its OligoPhore™ oligonucleotide delivery platform. The Company intends to develop the treatment under project code AM-401 with submission of an IND targeted for the end of 2022.

    Addressing high unmet medical need

    Colorectal cancer (CRC) is the fourth most commonly diagnosed cancer and the second leading cause of cancer death in the US.1 In 2021, there will be an estimated 149,500 new cases of CRC in the US, and 52,980 deaths from CRC.2 Approximately 40 to 50% of patients with CRC harbor mutations of the KRAS gene,3 which are known to contribute to the development, invasion and metastasis of CRC. KRAS encodes the Ras protein which controls - like an "on / off switch" – cell growth, cell maturation, and cell death. Through the mutations, the Ras proteins can be rendered persistently active, causing cancer cells to grow and spread in the body.

    Beside CRC, KRAS mutations are frequently observed in pancreatic cancer and lung cancer. Approximately 19% of patients with cancer harbor Ras mutations, equivalent to approximately 3.4 million new cases per year worldwide.4 Mutations in KRAS alone account for approximately one million deaths per year worldwide.5 Although the role of KRAS mutations in cancer has been known for decades, they have remained a challenging target for therapeutic interventions. Only recently two small molecule inhibitors of single KRAS mutations were approved in a breakthrough by the Food and Drug Administration (FDA) for use in the treatment of non-small cell lung cancer (NSCLC).

    Compelling results in KRAS-driven models of colorectal and pancreatic cancer

    The selection of CRC as the first therapeutic indication for the OligoPhore™ technology was made based on the high unmet medical need, compelling outcomes from studies with OligoPhore™ enabled KRAS silencing, and a well-defined regulatory and development pathway. In vitro and in vivo experiments conducted jointly by research teams from Washington University, St. Louis MO and the University of South Florida, Tampa FL, demonstrated efficient uptake of OligoPhore™ nanoparticles with KRAS-targeted siRNA in colorectal and pancreatic cancer cells, strong inhibition of KRAS expression, reduced viability of tumor cells and significant reduction in tumor growth and volume.6 Importantly, a murine model demonstrated the capacity of the OligoPhore™ platform to drive targeted delivery of the nanoparticles specifically to tumor cells.

    "In our preclinical studies with OligoPhore enabled siRNA delivery, we have demonstrated potent knock down of KRAS in a highly targeted and effective fashion, which inhibited a key driver of cancer cell proliferation and metastases", commented Samuel Wickline, MD, Auris Medical's Chief Scientific Officer. "Based on these compelling data and the results from our extensive review of strategic development options, we look forward to advancing OligoPhore first in colorectal cancer before applying the technology also to other therapeutic indications. Thanks to its flexibility and specificity, OligoPhore can be used to simultaneously deliver different siRNA payloads for broad target inhibition, which opens exciting novel therapeutic options."

    About OligoPhore

    OligoPhore™ is a versatile platform for safe and effective delivery of oligonucleotides such as siRNA (small interfering ribonucleic acid) into target cells, using systemic or local administration. It is based on a proprietary 21 amino acid peptide that can engage any type of RNA, including mRNA, in rapid self-assembly into a polyplex. The polyplex has a size, charge, and other physical features that allow it to escape hepatic clearance and thus to reach other target tissues than the liver. OligoPhore™ protects the RNA payload from degradation in the circulation and allows for rapid cellular uptake, while enabling pH-dependent nucleotide full endosomal escape and cytoplasmic delivery. Effective delivery and positive treatment outcomes have been demonstrated in more than 10 diverse murine models of disease for cancer, cardiovascular, and rheumatological targets in the NF-κB family, various members of the ETS transcription factor family, and targets in the JNK and TAM pathways.

    About Auris Medical

    Auris Medical is dedicated to developing therapeutics that address important unmet medical needs. The Company is currently active in three areas: the development of RNA therapeutics for extrahepatic therapeutic targets (OligoPhore™ / SemaPhore™ platforms; preclinical), nasal sprays for protection against airborne viruses and allergens (Bentrio™; pre-commercial) or the treatment of vertigo (AM-125; Phase 2), and the development of therapeutics for intratympanic treatment of tinnitus or hearing loss (Keyzilen® and Sonsuvi®, Phase 3). The Company was founded in 2003 and is headquartered in Hamilton, Bermuda with its main operations in Basel, Switzerland. The shares of Auris Medical Holding Ltd. trade on the NASDAQ Capital Market under the symbol "EARS." The Company will change its name to "Altamira Therapeutics Ltd." and its ticker symbol to "CYTO", subject to approval by a Special General Meeting of shareholders to be held on July 21, 2021.

    Forward-looking Statements

    This press release may contain statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or Auris Medical's strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may", "might", "will", "should", "expects", "plans", "anticipates", "believes", "estimates", "predicts", "projects", "potential", "outlook" or "continue", or the negative of these terms or other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the approval and timing of commercialization of AM-301, Auris Medical's need for and ability to raise substantial additional funding to continue the development of its product candidates, the timing and conduct of clinical trials of Auris Medical's product candidates, the clinical utility of Auris Medical's product candidates, the timing or likelihood of regulatory filings and approvals, Auris Medical's intellectual property position and Auris Medical's financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Auris Medical's capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption "Risk Factors" in Auris Medical's Annual Report on Form 20-F for the year ended December 31, 2020, and in Auris Medical's other filings with the SEC, which are available free of charge on the Securities Exchange Commission's website at: www.sec.gov. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated. All forward-looking statements and all subsequent written and oral forward-looking statements attributable to Auris Medical or to persons acting on behalf of Auris Medical are expressly qualified in their entirety by reference to these risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and Auris Medical does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law.

    Investor contact:


    1 Benson AB et al. (2021), NCCN clinical practice guidelines in oncology, colon cancer, version 2.2021, JNCCN 19(3):329-59.

    2 National Cancer Institute, https://seer.cancer.gov/statfacts/html/colorect.html

    3 Armstrong SA et al. (2020), Molecular profiling in metastatic colorectal cancer, Oncology (Williston Park) 34(9):352-5.

    4 Prior IA et al. (2020), The frequency of Ras mutations in cancer, Cancer Res 80(14):2969-74.

    5 Simanshu DK et al. (2017), RAS proteins and their regulators in human disease, Cell 170(1):17-33.

    6 Strand MS et al. (2019), Precision Delivery of RAS-inhibiting siRNA to KRAS driven cancer via peptide-based nanoparticles, OncoTarget 10(46):4761-75.



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  2. Hamilton, Bermuda, June 28, 2021 – Auris Medical Holding Ltd. (NASDAQ:EARS), a company dedicated to addressing unmet medical needs through RNA therapeutics, allergy and viral infection protection, and inner ear therapeutics, today announced that its affiliate Altamira Medica Ltd. will start the market roll-out of Bentrio™, its nasal spray for protection against airborne viruses and allergens, by launching it in Germany. Bentrio™ will shortly become available through selected online pharmacies; over the coming months, market coverage will be expanded progressively through additional distribution channels and in further countries.

    "Following the intense and concerted efforts by our team and external partners, we are very excited to make Bentrio…

    Hamilton, Bermuda, June 28, 2021 – Auris Medical Holding Ltd. (NASDAQ:EARS), a company dedicated to addressing unmet medical needs through RNA therapeutics, allergy and viral infection protection, and inner ear therapeutics, today announced that its affiliate Altamira Medica Ltd. will start the market roll-out of Bentrio™, its nasal spray for protection against airborne viruses and allergens, by launching it in Germany. Bentrio™ will shortly become available through selected online pharmacies; over the coming months, market coverage will be expanded progressively through additional distribution channels and in further countries.

    "Following the intense and concerted efforts by our team and external partners, we are very excited to make Bentrio available to consumers who are looking to reduce risks from exposure to airborne viruses and allergens", commented Ueli Fankhauser, Altamira Medica's Head of Commercial. "Despite the important progress with vaccination programs, the continued emergence of SARS-CoV-2 variants and lack of full herd immunity highlight the need for additional means for self-protection such as Bentrio."

    About Bentrio

    Bentrio™ (AM-301) is a drug-free nasal spray for personal protection against airborne viruses and allergens. Upon application into the nose, Bentrio™ forms a protective gel layer on the nasal mucosa. This thin film is designed to prevent the contact of viruses or allergens with cells; in addition, the composition serves to bind such particles and help with their discharge and to humidify the nasal mucosa. Together, this is designed to reduce the risk of upper respiratory tract viral infections and promote alleviation of allergic symptoms. In human nasal epithelium cells infected by SARS-CoV-2, Bentrio™ was shown to reduce the infectious viral load by more than 99% when used for prevention. Further, Bentrio™ was effective in slowing the growth of the viral titer when treatment started only 24 or 30 hours after infection. In allergy, a clinical investigation in a pollen challenge chamber demonstrated a significant reduction in the main symptoms of allergic rhinitis with the protective effect setting in rapidly and lasting for 4 hours.

    About Auris Medical

    Auris Medical is dedicated to developing therapeutics that address important unmet medical needs. The Company is currently active in three areas: the development of RNA therapeutics for extrahepatic therapeutic targets (OligoPhore™ / SemaPhore™ platforms; preclinical), nasal sprays for protection against airborne viruses and allergens (Bentrio™; pre-commercial) or the treatment of vertigo (AM-125; Phase 2), and the development of therapeutics for intratympanic treatment of tinnitus or hearing loss (Keyzilen® and Sonsuvi®, Phase 3). The Company was founded in 2003 and is headquartered in Hamilton, Bermuda with its main operations in Basel, Switzerland. The shares of Auris Medical Holding Ltd. trade on the NASDAQ Capital Market under the symbol "EARS." The Company will change its name to "Altamira Therapeutics Ltd." and its ticker symbol to "CYTO", subject to approval by a Special General Meeting of shareholders to be held on July 21, 2021.

    Forward-looking Statements

    This press release may contain statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or Auris Medical's strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may", "might", "will", "should", "expects", "plans", "anticipates", "believes", "estimates", "predicts", "projects", "potential", "outlook" or "continue", or the negative of these terms or other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the approval and timing of commercialization of AM-301, Auris Medical's need for and ability to raise substantial additional funding to continue the development of its product candidates, the timing and conduct of clinical trials of Auris Medical's product candidates, the clinical utility of Auris Medical's product candidates, the timing or likelihood of regulatory filings and approvals, Auris Medical's intellectual property position and Auris Medical's financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Auris Medical's capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption "Risk Factors" in Auris Medical's Annual Report on Form 20-F for the year ended December 31, 2020, and in Auris Medical's other filings with the SEC, which are available free of charge on the Securities Exchange Commission's website at: www.sec.gov. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated. All forward-looking statements and all subsequent written and oral forward-looking statements attributable to Auris Medical or to persons acting on behalf of Auris Medical are expressly qualified in their entirety by reference to these risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and Auris Medical does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law.

    Investor contact:

         



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    • Treatment with OligoPhoreTM siRNA stops aggressive ATLL tumor growth to near zero
    • Significant reduction in tumor size, spleen size and peripheral blood lymphocyte counts
    • Results add to extensive body of evidence for effective OligoPhoreTM enabled delivery of nucleic acids to extrahepatic tissues

    Hamilton, Bermuda, June 21, 2021 – Auris Medical Holding Ltd. (NASDAQ:EARS), a company dedicated to addressing unmet medical needs through RNA therapeutics, allergy and viral infection protection, and inner ear therapeutics, today announced the publication of positive results from an in vivo study demonstrating significant inhibition of tumor growth by siRNA knock-down of NF-κB employing its OligoPhoreTM technology in Adult T-cell Leukemia Lymphoma (ATLL…

    • Treatment with OligoPhoreTM siRNA stops aggressive ATLL tumor growth to near zero
    • Significant reduction in tumor size, spleen size and peripheral blood lymphocyte counts
    • Results add to extensive body of evidence for effective OligoPhoreTM enabled delivery of nucleic acids to extrahepatic tissues



    Hamilton, Bermuda, June 21, 2021 – Auris Medical Holding Ltd. (NASDAQ:EARS), a company dedicated to addressing unmet medical needs through RNA therapeutics, allergy and viral infection protection, and inner ear therapeutics, today announced the publication of positive results from an in vivo study demonstrating significant inhibition of tumor growth by siRNA knock-down of NF-κB employing its OligoPhoreTM technology in Adult T-cell Leukemia Lymphoma (ATLL). The article titled "Targeting NF-κB with nanotherapy in a mouse model of adult T-cell leukemia / lymphoma" was published in Nanomaterials, an international peer-reviewed open-access journal.1

    The study was performed jointly by research groups at Washington University, St. Louis MO, and the University of South Florida, Tampa FL. The researchers developed and evaluated RNA nanoparticles based on Auris Medical's OligoPhoreTM peptide carrier and siRNA targeting simultaneously two NF-κB signaling pathways. NF-κB is a protein complex that plays a key role in regulating the immune response to infection and is critical for tumor progression in ATLL. The siRNA nanoparticles were administered systemically to two groups of mice with either spontaneous ATLL tumor growth or tumor cell transplantation.

    The study demonstrated rapid delivery of siRNA to the tumor and significant reduction of target mRNA and protein expression, which altered the natural history of subsequent tumor progression. Tumor size, spleen size, and peripheral blood lymphocyte counts were significantly lower in treated mice compared to controls (p<0.01), and tumor growth was reduced to near zero in the most aggressive tumors. Further, the siRNA nanoparticles sensitized late-stage ATLL tumors to conventional chemotherapy with etoposide.

    ATLL is a rare and aggressive type of non-Hodgkin's lymphoma of mature T cells caused by the Human T-cell Leukemia / Lymphotropic Virus type 1 (HTLV 1). It can be found in the blood, lymph nodes, skin or other parts of the body. There are 5-10 million people infected with HTLV 1 globally, and it is estimated that 61 out of 100,000 of carriers will develop ATLL annually. The virus is endemic to Japan, sub Saharan Africa, South America, the Caribbean, central Australia, the Middle East, and Romania. Most cases are not curable with current treatments, even when diagnosed early. The 5-year survival rate is 23.4% with a median survival of 11 months. Overall survival has remained unchanged since the disease was first described.

    "We are very excited about the very encouraging results from the study in ATLL mice", commented Samuel Wickline, MD, Auris Medical's Chief Scientific Officer. "ATLL is a very challenging condition with high mortality rate. Although NF-κB has been known for some time as a promising target, it has remained elusive to specific and effective treatment so far. With the use of OligoPhore technology, siRNA targeting NF-κB can be delivered intravenously and track the tumor very effectively with profound suppression of aggressive tumor proliferation. Since ATLL is a highly malignant tumor with no targeted molecular therapy at present, this outcome is not only very encouraging for drug discovery and development in this therapeutic indication, but also for other tumors and inflammatory pathological conditions involving the NF-κB molecular target."

    About OligoPhoreTM

    OligoPhoreTM is a versatile platform for safe and effective delivery of oligonucleotides such as siRNA (small interfering ribonucleic acid) into target cells. It is based on a proprietary 21 amino acid peptide that can engage any type of RNA in rapid self-assembly into a polyplex. The polyplex has a size, charge, and other physical features that allow it to escape hepatic clearance and thus to reach other target tissues than the liver. OligoPhoreTM protects the RNA payload from degradation in the circulation and allows for rapid cellular uptake, while enabling pH-dependent nucleotide endosomal escape and cytoplasmic delivery. Effective delivery and positive treatment outcomes have been demonstrated in more than 10 murine models of disease for targets in the NF-κB family, various members of the ETS transcription factor family, and targets in the JNK and TAM pathways.

    About Auris Medical

    Auris Medical is dedicated to developing therapeutics that address important unmet medical needs. The Company is currently active in three areas: the development of RNA therapeutics for extrahepatic therapeutic targets (OligoPhoreTM / SemaPhoreTM platforms; preclinical), nasal sprays for protection against airborne viruses and allergens (BentrioTM; pre-commercial) or the treatment of vertigo (AM-125; Phase 2), and the development of therapeutics for intratympanic treatment of tinnitus or hearing loss (Keyzilen® and Sonsuvi®, Phase 3). The Company was founded in 2003 and is headquartered in Hamilton, Bermuda with its main operations in Basel, Switzerland. The shares of Auris Medical Holding Ltd. trade on the NASDAQ Capital Market under the symbol "EARS." The Company will change its name to "Altamira Therapeutics Ltd." and its ticker symbol to "CYTO", subject to approval by a Special General Meeting of shareholders to be held on July 21, 2021.

    Forward-looking Statements

    This press release may contain statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or Auris Medical's strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may", "might", "will", "should", "expects", "plans", "anticipates", "believes", "estimates", "predicts", "projects", "potential", "outlook" or "continue", or the negative of these terms or other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the approval and timing of commercialization of AM-301, Auris Medical's need for and ability to raise substantial additional funding to continue the development of its product candidates, the timing and conduct of clinical trials of Auris Medical's product candidates, the clinical utility of Auris Medical's product candidates, the timing or likelihood of regulatory filings and approvals, Auris Medical's intellectual property position and Auris Medical's financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Auris Medical's capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption "Risk Factors" in Auris Medical's Annual Report on Form 20-F for the year ended December 31, 2020, and in Auris Medical's other filings with the SEC, which are available free of charge on the Securities Exchange Commission's website at: www.sec.gov. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated. All forward-looking statements and all subsequent written and oral forward-looking statements attributable to Auris Medical or to persons acting on behalf of Auris Medical are expressly qualified in their entirety by reference to these risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and Auris Medical does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law.

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    1 Rauch DA et al. Targeting NF-κB with nanotherapy in a mouse model of adult T-cell leukemia/lymphoma. Nanomaterials 2021, 11(6), 1582.



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