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Data on Thelin Presented at the European Society of Cardiology Annual Congress
Houston (ots/PRNewswire) -
- Abstract Presented on Extension Data From STRIDE-1 Trial in Pulmonary Arterial Hypertension
Encysive Pharmaceuticals (Nasdaq: ENCY) today announced the presentation of data from a clinical study of Thelin(TM) (sitaxsentan) in pulmonary arterial hypertension (PAH), at the European Society of Cardiology Annual Congress in Munich. Data from the extension of Encysive's multi-center, pivotal Phase IIb/III STRIDE-1 (Sitaxsentan To Relieve ImpaireD Exercise) clinical trial was presented by clinical investigator Adaani Frost, M.D., Baylor College of Medicine, Houston, on Tuesday, August 31.
"The long-term evaluation results presented by Dr. Frost suggest that patients may continue to benefit from Thelin with chronic therapy, which we believe provides valuable information to the physician and patient communities in PAH," said Bruce D. Given, M.D., President and Chief Executive Officer of Encysive Pharmaceuticals. "In order to explore the full therapeutic potential of Thelin, our strategy has been to evaluate Thelin in the broadest population ever for this drug class, and to follow its long-term impact closely."
In the abstract entitled, "Long-term Sitaxsentan Therapy in Pulmonary Arterial Hypertension (PAH)" (E. Horn, et al.), data from the STRIDE-1 trial extension was analyzed to assess the time course to clinical improvement or deterioration with Thelin at doses of 100 mg and 300 mg.
Following treatment with a mean duration of 26 weeks and a maximum of 58 weeks, 53% of the 79 patients on 100 mg and 44% of the 91 patients on 300 mg improved at least one New York Heart Association (NYHA) functional class. A substantial portion of those individuals that improved did so within the initial 12 weeks of therapy -- 64% for 100 mg and 70% for 300 mg. During the first 12 weeks, liver-function abnormalities greater than three times the upper limit of normal occurred in 0% for 100 mg and 10% for 300 mg. Overall rates of 5% for 100 mg and 21% for 300 mg were reported for the entire treatment course. During treatment, only 5% of patients on 100 mg and 8% on 300 mg experienced NYHA functional class deterioration. While both doses of Thelin(TM) are similarly effective in improving functional class, both short- and long-term, the more favorable safety/efficacy profile of 100 mg lends further support to its selection as the maximum clinical dose in ongoing trials of Thelin.
About Thelin(TM) and PAH
Thelin is a small molecule that blocks the action of endothelin, a potent mediator of blood-vessel constriction and growth of smooth muscle in vascular walls. Endothelin receptor antagonists may prove to be effective in the treatment of a variety of diseases where the regulation of vascular constriction is important. Thelin is 6,500-fold selective in targeting the endothelin A receptor.
Pulmonary arterial hypertension (PAH) is a condition involving high blood pressure and structural changes in the walls of the pulmonary arteries, the blood vessels that connect the right side of the heart to the lungs. PAH causes shortness of breath, limits activity, and is eventually fatal unless treated successfully with heart and lung transplants. Primary and secondary PAH are estimated to afflict approximately 80,000 to 100,000 people worldwide, many of whom are children and young women.
Side effects of Thelin seen in the program to date, and which occurred more frequently than in placebo, include liver dysfunction (increased ALT and AST), headache, edema, constipation, nasal congestion and flushing. Because Thelin inhibits the metabolism of warfarin, the dose of warfarin should be adjusted downward when co-administered with Thelin.
About Encysive Pharmaceuticals
Encysive Pharmaceuticals Inc., a biopharmaceutical company focused on the discovery, development and commercialization of novel drugs, is recognized for our expertise in small molecule drug development and vascular biology. Argatroban, our first FDA-approved product, is being marketed by GlaxoSmithKline for heparin-induced thrombocytopenia. Encysive Pharmaceuticals is in Phase III development of the endothelin antagonist, Thelin, for pulmonary arterial hypertension. Our majority-owned affiliate, Revotar Biopharmaceuticals AG, is in Phase II development with the selectin antagonist bimosiamose in asthma, psoriasis and atopic dermatitis. Encysive Pharmaceuticals has several other research and development programs ongoing for a range of cardiovascular and inflammatory diseases. To learn more about Encysive Pharmaceuticals please visit our web site: http://www.encysive.com .
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are 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 timing and cost of our clinical trials, attainment of research and clinical goals and milestones of product candidates, attainment of required government approvals, sales levels of our products and availability of financing and revenues sufficient to fund development of product candidates and operations. In particular, careful consideration should be given to cautionary statements made in the various reports Encysive Pharmaceuticals, including as Texas Biotechnology Corporation, has filed with the Securities and Exchange Commission. The Company undertakes no duty to update or revise these forward-looking statements.
Web site: http://www.encysive.com
ots Originaltext: Encysive Pharmaceuticals Inc.
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