Texas Biotechnology Reports Additional Positive Phase IIA Trial Results in Congestive Heart Failure
July 21, 1998 07:02 PM
HOUSTON, July 21 /PRNewswire/ -- Texas Biotechnology Corporation today announced positive preliminary data for the second half of a double-blind, placebo-controlled Phase IIA congestive heart failure (CHF) trial evaluating the Company's endothelin A (ETA) receptor antagonist, TBC11251. The first half of the trial, reported in February of this year, was terminated early due to statistically significant interim results. The protocol was subsequently amended to allow further evaluation of TBC11251 at a higher dose. In both segments of the Phase IIA trial, the patients treated with TBC11251 demonstrated a statistically significant improvement versus placebo in the primary endpoint of improving central hemodynamics, particularly pulmonary vascular resistance. Positive trends were also observed in several other important cardiovascular measures.
Both segments of the study were conducted in patients with moderate to severe congestive heart failure (New York Heart Association class III/IV heart failure patients). The study involved a total of 48 patients. In the study, patients received either a single intravenous bolus dose of TBC11251 or placebo. No significant adverse events were observed in any of the patient groups. An abstract regarding the results of the trial has been submitted to the American Heart Association Scientific Sessions in November.
"This study is part of a growing body of evidence that endothelin receptor antagonists may be effective in relieving elevated pressure in the lungs and the right side of the heart," said Wilson S. Colucci, M.D., F.A.C.C., Professor of Medicine and Chief of Cardiovascular Medicine at Boston University School of Medicine, and principal investigator of the study. He added, "The pharmacologic profile of TBC11251 is unique among current agents and could play an important role in the treatment of heart failure, a very common condition which is associated with elevation of right heart pressures."
David B. McWilliams, President and Chief Executive Officer, "These results are encouraging and support continued development of the product which based on its effect on the right side of the heart is likely to be complementary to ACE inhibitors, a cornerstone of current CHF therapy. We intend to proceed with the filing of an Investigational New Drug Application (IND) for the oral formulation of TBC11251 and follow with additional Phase II trials with the oral form."
TBC11251 is a synthetic small molecule that selectively blocks endothelin A receptors. Elevations in endothelin levels have been shown to correlate with severity of heart failure and blocking endothelin may be a useful addition to the current treatment of CHF. According to the American Heart Association (AHA), CHF affects between 4 and 5 million Americans and recent AHA estimates suggest that CHF accounts for approximately $30 billion in healthcare spending in the United States.
Texas Biotechnology Corporation is a biopharmaceutical company focused on the development and commercialization of small molecule drugs to treat a variety of vascular conditions including cardiovascular disease and asthma. NOVASTAN, an injectable anticoagulant, is being co-developed with SmithKline Beecham. In addition to the development of NOVASTAN and TBC11251, the Company has completed an initial Phase IIA study for its novel selectin antagonist for asthma. Texas Biotechnology's expertise in vascular cell biology and its insights into computer-aided small molecule drug design has generated additional compounds for the inhibition of cell adhesion, endothelin, growth factors and programmed cell death.
This press release contains forward-looking information that is subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Among those risks, trends and uncertainties are attainment of research and clinical goals of product candidates. In particular, careful consideration should be given to cautionary statements made in the various reports Texas Biotechnology has filed with the Securities and Exchange Commission.
SOURCE Texas Biotechnology Corporation
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