Tenax Therapeutics Provides Update on Phase 2 Pulmonary Hypertension Clinical Trial
October 31 2019 - 8:00AM
Business Wire
- 15 patients have been randomized
- 83% initial response rate to qualify for randomization
- Pulmonary capillary wedge pressure (PCWP) was reduced , on
average, by 8 mmHg during exercise following the initial
levosimendan infusion
- No serious drug-related adverse events have been reported to
date
Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty
pharmaceutical company focused on identifying, developing and
commercializing products that address cardiovascular and pulmonary
diseases with high unmet medical need, today provided an update on
its on-going clinical trial of levosimendan.
Enrollment Update
Tenax is conducting a multi-center, double-blind placebo
controlled Phase 2 trial designed to evaluate levosimendan in
patients with pulmonary hypertension and heart failure with
preserved ejection fraction (PH-HFpEF). The study is also known as
the HELP Trial (Hemodynamic Evaluation of Levosimendan in Patients
with PH-HFpEF). The Company has activated all of its anticipate 15
sites which it believes will be sufficient to fully enroll the
trial. 15 patients, up from eight at the end of August, are
currently enrolled, out of the targeted 36 patients. Given the
current pace of patient enrollment, we continue to expect full
enrollment and top-line data in the first quarter of 2020.
Initial Response
The trial has a predefined response criterion that patients must
meet following a 24-hour open-label infusion of levosimendan before
they can be randomized to the 6-week double-blind phase of the
trial. The criterion for randomization is that PCWP measured during
supine exercise is ≥ 4mmHg less after the open-label infusion than
at baseline. 15 of the 18 patients, approximately 83%, achieved
this predefined responder criterion with a mean reduction of 8 mmHg
in PCWP.
Adverse Events
There have been no drug-related serious adverse events, and no
patients have withdrawn from the study. All of the patients who
have completed the 6-week double-blind phase of the trial have
elected to enroll in the open-label extension study.
Tenax CEO Tony DiTonno stated, “We are excited to provide this
interim update regarding the HELP Study enrollment and preliminary
responder information. While these open-label hemodynamic responses
are preliminary, it is encouraging to see such favorable responses.
We are very fortunate to have so many prominent investigators and
leading academic centers participating in the HELP Study.”
Dr. Stuart Rich, Director of the Pulmonary Vascular Disease
Program at the Bluhm Cardiovascular Institute at Northwestern
University and the principal investigator and architect for the
HELP Study stated, “The high initial response rate, and the
magnitude of the initial response with exercise has exceeded my
expectations. I remain very hopeful that we may have an effective
treatment for PH-HFpEF for the first time.”
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 team
including recognized global experts in pulmonary hypertension. The
Company owns North American rights to develop and commercialize
levosimendan and is currently enrolling 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 April 1, 2019,
its quarterly report on Form 10-Q filed on August 14, 2019 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20191031005067/en/
Investor Contact: ICR Stephanie Carrington, 646-277-1282
Stephanie.carrington@icrinc.com
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