All,
just stumbled on this. Looks good to me but WDIK. Any opinions out there. The stock has moved since the release but the market cap is still small vs market size of drugs. A bit like the old NBIX. Comments?
Thanks in advance,
LIATexas Biotechnology Reports Progress on Endothelin A Receptor Antagonist Program
Conference Call With Noted Endothelin Authority Set for Today at 4pm ET
HOUSTON, Oct. 14 /PRNewswire/ -- Texas Biotechnology Corporation (Amex: TXB - news) said preliminary results of a Phase II oral safety and tolerance dose-ranging study with sitaxsentan sodium (TBC11251), its endothelin A receptor antagonist, demonstrated statistically significant reductions in blood pressure in mild to moderate hypertensive patients.
Endothelin, one of the most potent vasoconstrictive substances in the body, exerts its effects through activation of both endothelin A and endothelin B receptors. The findings from this study provide the first demonstration of a potentially beneficial effect of a selective endothelin A receptor antagonist in hypertensive patients. Up to now, endothelin antagonists that have been tested in hypertensive patients have been non- selective, blocking both the A and B receptors. Since activation of the endothelin B receptor causes vasodilation, blocking only the A receptor may have advantages.
The oral study, together with scientific findings presented this week at the Sixth International Endothelin Conference in Montreal (Oct. 11-13), add further evidence that the Company's endothelin A receptor antagonist compounds may represent a new class of drugs to treat a number of different cardiovascular diseases.
``It is my belief that by blocking the negative effects of endothelin, we are likely to see positive improvements in certain cardiovascular patients,' stated David Langleben MD, FRCP¸, Associate Professor of Medicine, McGill University, Cardiology Division, Sir Mortimer B. Davis Jewish General Hospital. Dr. Langleben added, ``The results Texas Biotechnology has seen with sitaxsentan sodium, together with results presented by other companies and research institutions, demonstrate compelling progress in this area.'
The Texas Biotechnology abstracts presented at the Sixth International Endothelin Conference described several different scientific studies involving sitaxsentan sodium, plus two second generation compounds with higher selectivity and greater potency, TBC3214 and TBC3711. The overall results of these studies confirm endothelin A receptor antagonists reduce pulmonary pressure, lower systemic blood pressures and vascular remodeling in various disease models. See Exhibit I for a description of the abstracts presented.
Oral Safety and Tolerability Study in Hypertension Patients (Study 220) -- The primary objective of the open label, single center study of mild to moderate hypertensive patients reported today is to compare the safety and tolerability of sitaxsentan sodium at three different doses twice daily for 14 days in mild to moderate hypertension patients (10 patients per group). In addition to assessing dose and tolerability, the trial is monitoring changes in patient cardiovascular parameters, such as blood pressure, heart rate and plasma endothelin levels. Most drugs used to treat hypertension tend to require several weeks to demonstrate reductions in blood pressure. The fact that Study 220 demonstrated statistically significant, dose-dependent results in blood pressure among the first two groups of patients after only one week and sustained these results through the second week is very encouraging. As importantly, the compound has been well tolerated at the two initial dose levels.
Richard A.F. Dixon, Ph.D., Vice President, Research at Texas Biotechnology stated, ``The ability to reduce the diastolic and systolic blood pressures in these patients, in a statistically significant fashion, in such a short period of time, is a very positive signal and may justify evaluating the product in hypertension.' Dr. Dixon added, ``These results, combined with the data we saw in chronic heart failure patients, give us further confidence in the therapeutic potential of sitaxsentan sodium. With this clear clinical response, we now have a dose we can take forward in both chronic heart failure and in a second indication, pulmonary arterial hypertension.'
Pulmonary arterial hypertension is a cardiopulmonary disorder in which endothelin levels are elevated and pressure in the pulmonary artery (the blood vessel that leads from the heart to the lungs) rises above normal levels. It is a progressive, life-threatening, incurable disease that is difficult to diagnose and treat. Possible clinical outcomes are an improvement in exercise capacity, quality of life and increased survival.
A Phase IIa open label safety and tolerability trial in patients with pulmonary arterial hypertension will include 20 patients and is scheduled to begin enrollment later this month.
David B. McWilliams, President and CEO of Texas Biotechnology, stated, ``Based on the clear unmet medical need of these patients, the pulmonary arterial hypertension indication may represent an accelerated clinical path for sitaxsentan sodium. If the first Phase IIa trial is positive, we will work closely with the FDA to design a Phase III trial that, if positive, could be sufficient to support approval.'
Texas Biotechnology is a biopharmaceutical company focused on the development and commercialization of small molecule drugs to treat a variety of diseases including thrombosis, chronic heart failure and asthma. |
