Tenax Therapeutics Inc (NASDAQ:TENX) a specialty pharmaceutical firm focused on identifying, advancing and commercializing offerings for the critical care industry, released top-line report from its Phase III LEVO-CTS study.
The trial failed to achieve statistically notable decline in the double endpoint of death or application of a mechanical support device at 30 days. However, the trial showed statistically considerable decline in two of three secondary objectives including reduction in LCOS and a decline in postoperative application of secondary inotropes.
Subject visits for death data through day 90 have yet to be closed. The firm has a meeting planned with the U.S. FDA to assess the preliminary study report and discuss a course to bring this possibly lifesaving treatment to the patients’ benefit suffering serious cardiac surgery.
The experts view
John Kelley, the CEO of Tenax Therapeutics, reported that they are surprised and disappointed by the top-line report from this study, particularly given the promising data from earlier published clinical studies. On contrary, they are exhilarated by the statistically substantial decline in incidence of LCOS and application of postoperative secondary inotropes.
This is steady with what the management know about how this medication works. Additionally, they continue to assess the full data set, comprising the in-process results compilation on all-cause mortality all through day 90. They will share their complete findings at the planned American College of Cardiology meeting in March. The CEO added that they thank their clinical collaborators and subjects who joined in this clinical study with the anticipation of improving their own outcomes as well as the results of future patients looking for cardiac surgery.
Assessment of the LEVO-CTS study results are continuing and will be offered on March 19, 2017, during a clinical trial session at the ACC Annual Scientific Session to be held in Washington, D.C.