Benzinga | Nov 10, 2020 08:42AM EST

Tenax Therapeutics Highlights Presentation Of 24-Hour HELP Study Results At American Heart Association Meeting Nov. 13

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/ Available OnDemand beginning Friday, November 13, 2020 at 9:00 a.m.Time: 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."