TENX Tenax Therapeutics Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Levosimendan
Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF)
|
Phase 2
Phase 2
|
Phase 2 top-line data released June 2, 2020. Primary endpoint (Pulmonary Capillary Wedge Pressure (PCWP) with bicycle exercise) not met. Various secondary endpoints met.
|
|
Levosimendan
Reduce the incidence of low cardiac output syndrome during cardiac surgery
|
Phase 3
Phase 3
|
Phase 3 top line data released January 31, 2017 - primary endpoints not met.
|
|
Levosimendan
Septic shock
|
Phase 2b
Phase 2b
|
Phase 2b trial did not meet primary endpoint.
|
Latest News
-
View Full Article Hide Full Article
-Conference to be held at 4:30 pm EST on January 21, 2021-
Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today announced that it will host an investor conference call for analysts and investors on Thursday, January 21, 2021 at 4:30 p.m. EST. On the call, management will review the previously announced acquisition of PH Precision Med (PHPM), a privately-held clinical stage biotech company focused on developing imatinib for the treatment of pulmonary arterial hypertension (PAH), and the clinical development plan to advance a delayed release oral formulation of imatinib, designed to avoid the gastric irritation, into a single pivotal trial pursuant to the 505(b)(2) pathway.
A live webcast of the conference call and accompanying slides will be available under "Events and Presentations" in the Investors section of the Company's website at investors.tenaxthera.com. The conference call can be accessed by dialing (877) 405-1242 from the U.S. and (201) 389-0852 internationally, followed by the conference ID: 13715313. An archived webinar recording of the event will be available on the website for approximately 30 days.
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company has a world-class scientific advisory team including recognized global experts in pulmonary hypertension. The Company owns North American rights to develop and commercialize levosimendan and has recently released topline data regarding their Phase 2 clinical trial for the use of levosimendan in the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF). Tenax plans to advance a delayed release oral formulation of imatinib, designed to avoid the gastric irritation, into a single pivotal trial pursuant to the 505(b)(2) pathway. For more information, visit www.tenaxthera.com.
About Levosimendan
Levosimendan is a calcium sensitizer that works through a unique triple mechanism of action. It initially was developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland, and is currently approved in over 60 countries for this indication and not available in the United States. Tenax Therapeutics acquired North American rights to develop and commercialize levosimendan from Phyxius Pharma, Inc.
About Imatinib
Imatinib is an antiproliferative agent developed to target the BCR-ABL tyrosine kinase in patients with chronic myeloid leukemia. The inhibitory effects of imatinib on PDGF receptors and c-KIT suggested that it may be efficacious in PAH. Imatinib reversed experimentally induced pulmonary hypertension and has pulmonary vasodilatory effects in animal models and proapoptotic effects on pulmonary artery smooth muscle cells from patients with idiopathic PAH. In a phase 3 clinical trial imatinib produced significant improvements in exercise capacity, but a high rate of dropouts attributed largely to gastric intolerance prevented regulatory approval.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by the Company that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to matters beyond the Company's control that could lead to delays in the clinical study, new product introductions and customer acceptance of these new products; matters beyond the Company's control that could impact the Company's continued compliance with Nasdaq listing requirements; the impact of management changes on the Company's business and unanticipated charges, costs and expenditures not currently contemplated that may occur as a result of management changes; and other risks and uncertainties as described in the Company's filings with the Securities and Exchange Commission, including in its annual report on Form 10-K filed on March 30, 2020, and its quarterly report on Form 10-Q filed on November 16, 2020, as well as its other filings with the SEC. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management's future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210120005056/en/
-
View Full Article Hide Full Article
- Expands pipeline into Pulmonary Arterial Hypertension (PAH), a progressive, fatal orphan disease without a cure
- Imatinib, a tyrosine kinase inhibitor (TKI), has been shown to block critical disease promoting pathways and has demonstrated improved exercise capacity and hemodynamics in patients with advanced PAH
- Acquisition strengthens leadership team with appointment of Dr. Stuart Rich as Chief Medical Officer
Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying, developing, and commercializing products for the critical care market, today announced the acquisition of PH Precision Med (PHPM), a privately-held clinical stage biotech company focused on developing imatinib for the treatment of pulmonary arterial hypertension (PAH). The FDA has granted Orphan Drug Designation for imatinib for the treatment of PAH, an indication with a high unmet medical need.
The acquisition expands Tenax's pulmonary hypertension pipeline with the addition of imatinib, a Phase 3 ready candidate. Imatinib is a tyrosine kinase inhibitor (TKI) that transformed the treatment of cancer by blocking the underlying pathways resulting in long lasting remissions. Subsequent preclinical and clinical studies in PAH indicate that imatinib may provide antiproliferative and disease-modifying effects in PAH patients through its ability to inhibit several growth factors including platelet-derived growth factor (PDGF). PDGF regulates vascular smooth muscle cell proliferation in PAH and is thought to be associated with the disease progression. Multiple clinical studies of imatinib in PAH patients provide convincing evidence that imatinib can provide impressive improvements in exercise capacity and hemodynamics in patients with advanced PAH. The strong efficacy results from these trials, combined with imatinib's antiproliferative mechanism action, have raised the possibility that imatinib may work by modifying the underlying PAH disease process. Pursuant to the acquisition, Tenax's clincial development plan includes advancing a delayed release oral formulation of imatinib, designed to avoid the gastric irritation, into a single pivotal trial pursuant to the 505(b)(2) pathway.
"The acquisition of PHPM immediately expands Tenax's pipeline to include a second de-risked Phase 3 ready candidate with the potential to be the first disease modifying treatment of pulmonary arterial hypertension," said Anthony DiTonno, Chief Executive Officer of Tenax. "The previous clinical trial designs led to high dropout rates and raised questions related to safety and tolerability, which limited further development of imatinib in PAH. We believe that PHPM's innovative clinical development plan, which includes a novel formulation that mitigates the side effects without diminishing the bioavailability, has the potential to yield positive clinical outcomes in a single pivotal Phase 3 trial requisite for regulatory approval."
Stuart Rich, MD, co-founder of PHDM, has been appointed Chief Medical Officer of Tenax Therapeutics. Dr. Rich currently serves as Professor of Medicine at Northwestern University Feinberg School of Medicine, and Director of the Pulmonary Vascular Disease Program at the Bluhm Cardiovascular Institute. He previously served as FDA Cardio-Renal Advisory Committee Member.
Mr. DiTonno continued, "In addition to this transformative asset, we are also pleased to welcome PHPM's co-founder Dr. Rich to the Tenax management team. Dr. Rich is a pioneer in the field of pulmonary hypertension and its treatments. In addition, his many years of experience as an FDA advisory committee member provides Tenax with extraordinary knowledge of pulmonary hypertension disease mechanisms and modern regulatory strategies. I am confident this strengthened team is well positioned to maximize the clinical potential of imatinib and advance the clinical development of levosimendan for PH-HFpEF, which together have the potential to address significant unmet needs and large market opportunities."
At the next regularly scheduled Board meeting, Dr. Rich is expected to be appointed to Tenax's Board of Directors. In addition, in connection with Tenax's 2021 Annual Meeting of Stockholders, two additional co-founders of PHPM, Declan Doogan, MD and Michael Davidson, MD, are expected to be nominated to join to Tenax's Board of Directors. Dr. Doogan is a drug development executive with more than 30 years of experience in the pharmaceutical industry. After retiring from Pfizer in 2007 as the Senior VP Head of World Drug Development he was Head of R&D at Amarin where he helped raised $100 million to fund the reorganization leading to completion of a Phase 3 program and approval for Vascepa. He is cofounder and Chair of Biohaven (BHVN: NYSE) and co-founder of the healthy aging company Juvenescence. Dr. Davidson was founder of Omthera Pharmaceuticals, co-founder of Corvidia Therapeutics, Inc., and is currently Chief Executive Officer of New Amsterdam Pharma. Together they bring extensive experience of successful biotech development and leadership.
Dr. Rich remarked, "This acquisition by Tenax, a clinical-stage publicly traded company with a pulmonary hypertension focus, is testament to the PHPM team's success in developing our novel and highly innovative clinical development plan. We will now focus advancing therapeutic candidates for Group 1 and Group 2 pulmonary hypertension with a precision medicine approach, to allow us to achieve the optimal treatment effects in our clinical trials. I look forward to joining the Tenax team to unlock the clinical potential of imatinib for patients with severe PAH."
In connection with his appointment, on January 15, 2021, Dr. Rich was awarded an option to purchase 250,000 shares of the Company's common stock. This award was made in accordance with the employment inducement award exemption provided by Nasdaq Rule 5635(c)(4) and was therefore not awarded under the Company's stockholder approved equity plan. The option award will vest as follows: 25% upon initiation of a Phase 3 trial; 25% upon database lock; 25% upon acceptance for review of an NDA; and 25% upon approval. The options have a 10-year term and an exercise price of $1.78 per share, the January 15, 2021 closing price of the Company's common stock.
In connection with the acquisition, Tenax will issue to PHPM's stockholders in a private placement an aggregate of approximately 12.1 million unregistered shares of common stock and securities convertible into common stock. These securities were issued as follows at closing:
(i) 1,892,905 shares of Tenax Common Stock, representing approximately 15% of Tenax's outstanding Common Stock prior to closing, and
(ii) 10,232 shares of Class B Preferred Stock that, following stockholder approval, will be converted into up to 10,232,000 shares of Common Stock. The Preferred Stock will have voting rights equal to approximately 4.99% of the Company's pre-transaction shares outstanding, such that the total voting rights of shares issued in the transaction prior to stockholder approval will not exceed 19.99% of the pre-transaction outstanding common stock.
Stockholder approval was not required and was not sought for the consummation of the acquisition; however, Tenax intends to seek stockholder approval for the full issuance of the securities contemplated in the transaction. A more complete description of the acquisition is available in the Form 8-K filed by Tenax Therapeutics with the Securities and Exchange Commission (the "SEC") on January 19, 2021. This press release is neither an offer to sell nor a solicitation of an offer to buy any of the Tenax Therapeutics' securities. No offer, solicitation, or sale will be made in any jurisdiction in which such offer, solicitation, or sale is unlawful. The terms and conditions of the transactions described in this press release are qualified in their entirety by reference to the transaction documents, which were filed on January 19, 2021 with the SEC on Form 8-K.
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company has a world-class scientific advisory team including recognized global experts in pulmonary hypertension. The Company owns North American rights to develop and commercialize levosimendan and has recently released topline data regarding their Phase 2 clinical trial for the use of levosimendan in the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF). For more information, visit www.tenaxthera.com.
About Levosimendan
Levosimendan is a calcium sensitizer that works through a unique triple mechanism of action. It initially was developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland, and is currently approved in over 60 countries for this indication and not available in the United States. Tenax Therapeutics acquired North American rights to develop and commercialize levosimendan from Phyxius Pharma, Inc.
About Imatinib
Imatinib is an antiproliferative agent developed to target the BCR-ABL tyrosine kinase in patients with chronic myeloid leukemia. The inhibitory effects of imatinib on PDGF receptors and c-KIT suggested that it may be efficacious in PAH. Imatinib reversed experimentally induced pulmonary hypertension and has pulmonary vasodilatory effects in animal models and proapoptotic effects on pulmonary artery smooth muscle cells from patients with idiopathic PAH. In a phase 3 clinical trial imatinib produced significant improvements in exercise capacity, but a high rate of dropouts attributed largely to gastric intolerance prevented regulatory approval.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by the Company that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to matters beyond the Company's control that could lead to delays in the clinical study, new product introductions and customer acceptance of these new products; matters beyond the Company's control that could impact the Company's continued compliance with Nasdaq listing requirements; the impact of management changes on the Company's business and unanticipated charges, costs and expenditures not currently contemplated that may occur as a result of management changes; and other risks and uncertainties as described in the Company's filings with the Securities and Exchange Commission, including in its annual report on Form 10-K filed on March 30, 2020, and its quarterly report of Form 10-Q filed on November 16, 2020, as well as its other filings with the SEC. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management's future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210119005256/en/
-
View Full Article Hide Full Article
Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today reported financial results for the third quarter 2020 and provided a business update.
Tenax will share updates related to levosimendan and its recently completed Phase 2 trial for the treatment of patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF) on Wednesday, November 18, 2020 at 4:30 p.m. EST. The event will feature presentations from three globally recognized experts in the areas of pulmonary hypertension and heart failure with preserved ejection fraction, as well as a Q&A panel discussion. A live webcast of the Virtual R&D Webinar and accompanying slides will be available under "Events and Presentations" in the Investors section of the Company's website at www.tenaxthera.com. The Virtual R&D Webinar can also be accessed by dialing (866) 301-1155 from the U.S. and (914) 987-7396 internationally, followed by the conference ID: 5783678. An archived webinar recording of the event will be available on the website for approximately 30 days.
"We are moving forward with our plan to enter Phase 3 of our clinical development program of levosimendan in PH-HFpEF and expect to reach an agreement with the FDA on a path forward before the end of the first quarter next year. The recent announcement related to adding the oral formulation of levosimendan by expanding our license agreement with Orion is an exciting opportunity for us. We believe an oral dosage form will be more convenient to patients in the Phase 3 program, thus potentially making the trial easier to enroll and perhaps shortening the overall time to complete the program. As we finalize our plans, we will provide additional updates," stated Anthony DiTonno, Chief Executive Officer of Tenax. "We recently convened our Scientific Advisory Board to provide an in-depth review of the results of the HELP trial. The results of the Phase 2 trial received significant interest from the academic community at detailed presentations at the recent AHA and HFSA medical meetings. The R&D webinar on November 18th will be our first opportunity to provide access to a comprehensive review of the data to the investor community."
Recent Highlights
- On November 13, 2020, data from the 24-hour open-label portion of the HELP Study was presented during the American Heart Association (AHA) Scientific Sessions 2020 by Daniel Burkhoff, MD, PhD, Director Heart Failure, Hemodynamics and MCS Research at the Cardiovascular Research Foundation., et al. The Phase 2 HELP Study enrolled patients with pulmonary hypertension and heart failure with preserved ejection fraction and was designed to evaluate levosimendan's hemodynamic and clinical effects during rest and exercise. The initial phase of the trial was open-label and designed to identify patients who elicited a hemodynamic response following a 24-hour infusion of levosimendan. Patients who met the pre-specified response criteria of ≥4 mmHg reduction in pulmonary capillary wedge pressure during supine bicycle exercise were deemed to be responders and were randomized to a 6-week double-blind placebo-controlled phase of the trial.
- On October 9, 2020, Tenax signed an amendment to the existing licensing agreement with Orion Pharmaceuticals to include the rights to develop and commercialize in the United States and Canada an oral formulation of levosimendan for use with Type 2 pulmonary hypertension in heart failure patients with preserved ejection fraction (PH-HFpEF), or other pulmonary hypertension or heart failure related indications. The Company recently completed a Phase 2 study in PH-HFpEF using an intravenous formulation of levosimendan, which the Company has exclusive development and commercialization rights to in the US and Canada under the existing license agreement. Tenax expects to use the oral formulation in its upcoming Phase 3 trial in PH-HFpEF.
- On October 3, 2020, detailed results from the Phase 2 HELP Study of levosimendan in PH-HFpEF were presented at the Heart Failure Society of America (HFSA) Virtual Annual Scientific Meeting by Barry Borlaug, MD, Chair for Research, Division of Circulatory Failure, Department of Cardiovascular Medicine at the Mayo Clinic.
Financial Results
- Research and development expenses for the third quarter of 2020 were $1.0 million, compared to $900,000 for the third quarter of 2019.
- General and administrative expenses for the third quarter of 2020 were $1.2 million, compared to $1.3 million for the third quarter of 2019.
- Net loss for the third quarter of 2020 was $2.2 million, or $0.18 per share, compared to a net loss of $2.2 million, or $0.33 per share, for the third quarter of 2019.
- Cash, cash equivalents and marketable securities totaled $8.7 million as of September 30, 2020, compared with $5.4 million as of December 31, 2019.
- Management expects that current cash, cash equivalents and marketable securities will be sufficient to fund current operations through the third quarter of 2021.
About Phase 2 HELP Trial
The HELP Study (Hemodynamic Evaluation of Levosimendan in PH-HFpEF) was a multi-center, double-blind, placebo-controlled Phase 2 clinical trial designed to evaluate levosimendan in 36 patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). Endpoints in the trial evaluated various invasive hemodynamic and clinical measures including a 6-minute walk test. The Company previously announced positive topline results from this Phase 2 trial. The trial demonstrated a significant reduction in right atrial and pulmonary capillary wedge pressures. It also demonstrated a significant improvement with 6-minute walk distance.
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company has a world-class scientific advisory team including recognized global experts in pulmonary hypertension. The Company owns North American rights to develop and commercialize levosimendan and has recently released topline data regarding their Phase 2 clinical trial for the use of levosimendan in the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF). For more information, visit www.tenaxthera.com.
About Levosimendan
Levosimendan is a calcium sensitizer that works through a unique triple mechanism of action. It initially was developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland, and is currently approved in over 60 countries for this indication and not available in the United States. Tenax Therapeutics acquired North American rights to develop and commercialize levosimendan from Phyxius Pharma, Inc.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by the Company that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to matters beyond the Company's control that could lead to delays in the clinical study, new product introductions and customer acceptance of these new products; matters beyond the Company's control that could impact the Company's continued compliance with Nasdaq listing requirements; the impact of management changes on the Company's business and unanticipated charges, costs and expenditures not currently contemplated that may occur as a result of management changes; and other risks and uncertainties as described in the Company's filings with the Securities and Exchange Commission, including in its annual report on Form 10-K filed on March 30, 2020, and its quarterly report on Form 10-Q filed on November 16, 2020, as well as its other filings with the SEC. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management's future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
TENAX THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
Three months ended September 30,
Nine months ended September 30,
2020
2019
2020
2019
(Unaudited) (Unaudited) (Unaudited) (Unaudited) Operating expenses General and administrative $
1,172,725
$
1,343,429
$
3,364,890
$
3,692,843
Research and development 1,052,398
916,984
3,669,761
2,049,004
Total operating expenses 2,225,123
2,260,413
7,034,651
5,741,847
Net operating loss 2,225,123
2,260,413
7,034,651
5,741,847
Interest expense 610
-
1,016
-
Other income, net (5,298
)
(36,709
)
(14,038
)
(139,161
)
Net loss $
2,220,435
$
2,223,704
$
7,021,629
$
5,602,686
Unrealized loss (gain) on marketable securities 1,171
960
(445
)
(803
)
Total comprehensive loss $
2,221,606
$
2,224,664
$
7,021,184
$
5,601,883
Net loss per share, basic and diluted $
(0.18
)
$
(0.33
)
$
(0.73
)
$
(0.93
)
Weighted average number of common shares outstanding, basic and diluted 12,427,355
6,741,084
9,590,741
6,011,304
TENAX THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
September 30, 2020 December 31, 2019 (Unaudited) ASSETS Current assets Cash and cash equivalents $
8,235,532
$
4,905,993
Marketable securities 472,648
493,884
Prepaid expenses 189,275
780,952
Total current assets 8,897,455
6,180,829
Right of use asset 87,285
169,448
Property and equipment, net 3,461
6,559
Other assets 8,435
8,435
Total assets $
8,996,636
$
6,365,271
LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities Accounts payable $
1,052,824
$
1,661,054
Accrued liabilities 295,451
871,341
Note payable 30,900
-
Total current liabilities 1,379,175
2,532,395
Long term liabilities Note payable 213,757
-
Lease liability -
60,379
Total long term liabilities 213,757
60,379
Total liabilities 1,592,932
2,592,774
Commitments and contingencies; see Note 7 Stockholders' equity Preferred stock, undesignated, authorized 9,999,790 shares; See Note 8 Series A Preferred stock, par value $.0001, issued and outstanding 210 and 38,606, respectively -
4
Common stock, par value $.0001 per share; authorized 400,000,000 shares; issued and outstanding 12,619,369 and 6,741,860, respectively 1,262
674
Additional paid-in capital 250,591,604
239,939,797
Accumulated other comprehensive gain 903
458
Accumulated deficit (243,190,065
)
(236,168,436
)
Total stockholders' equity 7,403,704
3,772,497
Total liabilities and stockholders' equity $
8,996,636
$
6,365,271
View source version on businesswire.com: https://www.businesswire.com/news/home/20201116005957/en/
-
View Full Article Hide Full Article
- HELP Study results presentation will be available online beginning on November 13, 2020 at 9:00 a.m CST
Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying, developing, and commercializing products for the critical care market, today announced that data from the 24-hour open-label portion of the HELP (Hemodynamic Evaluation of Levosimendan in PH-HFpEF) Study will be presented during the American Heart Association (AHA) Scientific Sessions 2020 that is being conducted online from November 13, 2020 – November 17, 2020.
The phase 2 HELP Study enrolled patients with pulmonary hypertension and heart failure with preserved ejection fraction and was designed to evaluate levosimendan's hemodynamic and clinical effects during rest and exercise. The initial phase of the trial was open-label and designed to identify patients who elicited a hemodynamic response following a 24-hour infusion of levosimendan. Patients who met the prespecified response criteria of ≥4 mmHg reduction in pulmonary capillary wedge pressure during supine bicycle exercise were deemed to be responders and were randomized to a 6-week double-blind placebo-controlled phase of the trial.
The 24-hour HELP Study results being presented at AHA include data from a total of 44 patients, of which 36 (~85%) were determined to be responders. Details regarding the presentation are as follows:
Title:
24-hour Levosimendan Infusion Decreases Biventricular Filling Pressures at Rest and Exercise in PH-HFpEF
Author:
Daniel Burkhoff, MD PhD, Director Heart Failure, Hemodynamics and MCS Research at the Cardiovascular Research Foundation., et al
Session:
Novel Translational Insights for Pulmonary Vascular and RV Remodeling
Date/Time:
Available OnDemand beginning Friday, November 13, 2020 at 9:00 a.m. CST
The above presentation will be available to conference registrants for viewing on the AHA Scientific Session's Virtual Platform at https://professional.heart.org/es/meetings/scientific-sessions.
Tenax Therapeutics' CEO, Tony Ditonno, stated, "We are very excited to have these additional HELP Study results presented at the American Heart Association meeting. The results are very complimentary and supportive of the 6 week-double blind randomized phase of the HELP Study that was recently presented as a late-breaking clinical trial at the Heart Failure of Society of America, and we are very excited to have this additional 24-hour data being shared at this major scientific forum."
About Phase 2 HELP Trial
The HELP Study (Hemodynamic Evaluation of Levosimendan in PH-HFpEF) was a multi-center, double-blind, placebo-controlled Phase 2 clinical trial designed to evaluate levosimendan in 36 patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). Endpoints in the trial evaluated various invasive hemodynamic and clinical measures including a 6-minute walk test. The Company previously announced positive topline results from this Phase 2 trial. The trial demonstrated significant reduction in right atrial and pulmonary capillary wedge pressures. It also demonstrated a significant improvement with 6-minute walk distance.
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company has a world-class scientific advisory team including recognized global experts in pulmonary hypertension. The Company owns North American rights to develop and commercialize levosimendan and has recently released topline data regarding their Phase 2 clinical trial for the use of levosimendan in the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF). For more information, visit www.tenaxthera.com.
About Levosimendan
Levosimendan is a calcium sensitizer that works through a unique triple mechanism of action. It initially was developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland, and is currently approved in over 60 countries for this indication and not available in the United States. Tenax Therapeutics acquired North American rights to develop and commercialize levosimendan from Phyxius Pharma, Inc.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by the Company that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to matters beyond the Company's control that could lead to delays in the clinical study, new product introductions and customer acceptance of these new products; matters beyond the Company's control that could impact the Company's continued compliance with Nasdaq listing requirements; the impact of management changes on the Company's business and unanticipated charges, costs and expenditures not currently contemplated that may occur as a result of management changes; and other risks and uncertainties as described in the Company's filings with the Securities and Exchange Commission, including in its annual report on Form 10-K filed on March 30, 2020, and its quarterly report of Form 10-Q filed on August 14, 2020, as well as its other filings with the SEC. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management's future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201110005229/en/
-
View Full Article Hide Full Article
Webinar Scheduled for 4:30 pm EST on November 18
Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today announced that it will host a virtual R&D webinar for analysts and investors on Wednesday, November 18, 2020 at 4:30 p.m. EST.
Tenax will share updates related to levosimendan and its recently completed Phase 2 trial for the treatment of patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). The event will feature presentations from three globally recognized experts in the areas of pulmonary hypertension and heart failure with preserved ejection fraction, as well as a Q&A panel discussion. The speakers will include:
- Stuart Rich, MD, Professor of Medicine, Northwestern University Feinberg School of Medicine
- Daniel Burkhoff, MD, PhD, Director Heart Failure, Hemodynamics and MCS Research at the Cardiovascular Research Foundation
- Barry Borlaug, MD, Professor of Medicine, Mayo Clinic
A live webcast of the Virtual R&D Webinar and accompanying slides will be available under "Events and Presentations" in the Investors section of the Company's website at www.tenaxthera.com. An archived webinar recording of the event will be available on the website for approximately 30 days. If you are a member of the investment community and would like to attend, please RSVP to [email protected].
About Phase 2 HELP Trial
The HELP Study (Hemodynamic Evaluation of Levosimendan in PH-HFpEF) was a multi-center, double-blind, placebo-controlled Phase 2 clinical trial designed to evaluate levosimendan in 36 patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). Endpoints in the trial evaluated various invasive hemodynamic and clinical measures including a 6-minute walk test. The Company previously announced positive topline results from this Phase 2 trial. The trial demonstrated significant reduction in right atrial and pulmonary capillary wedge pressures. It also demonstrated a significant improvement with 6-minute walk distance.
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company has a world-class scientific advisory team including recognized global experts in pulmonary hypertension. The Company owns North American rights to develop and commercialize levosimendan and has recently released topline data regarding their Phase 2 clinical trial for the use of levosimendan in the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF). For more information, visit www.tenaxthera.com.
About Levosimendan
Levosimendan is a calcium sensitizer that works through a unique triple mechanism of action. It initially was developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland, and is currently approved in over 60 countries for this indication and not available in the United States. Tenax Therapeutics acquired North American rights to develop and commercialize levosimendan from Phyxius Pharma, Inc.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by the Company that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to matters beyond the Company's control that could lead to delays in the clinical study, new product introductions and customer acceptance of these new products; matters beyond the Company's control that could impact the Company's continued compliance with Nasdaq listing requirements; the impact of management changes on the Company's business and unanticipated charges, costs and expenditures not currently contemplated that may occur as a result of management changes; and other risks and uncertainties as described in the Company's filings with the Securities and Exchange Commission, including in its annual report on Form 10-K filed on March 30, 2020, and its quarterly report on Form 10-Q filed on August 14, 2020, as well as its other filings with the SEC. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management's future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201106005042/en/