Tracleer and PPH News Encysive Announces Six Thelin(TM) Abstracts Presented at American Thoracic Society International Conference
HOUSTON, May 22 /PRNewswire-FirstCall/ -- Encysive Pharmaceuticals (Nasdaq: ENCY - News) today announced that investigators presented six poster presentations of Thelin(TM) (sitaxsentan) studies in pulmonary arterial hypertension (PAH), at the annual International Conference of the American Thoracic Society (ATS) in San Diego. An oral presentation of STRIDE-2 data will be presented at ATS on Monday, May 23, followed by an investor presentation to be webcast at http://www.encysive.com . The first poster presentation, "Comparison of Placebo-Controlled and Open Label Trials in Pulmonary Arterial Hypertension" (A. Moeller, et al.), assessed placebo and non-placebo controlled trials of five PAH drugs with six- minute walk (6MW) data available, and compared the mean change from baseline observed for the same drugs under the different experimental conditions. The five PAH drugs for which both placebo and non-placebo controlled 6MW data were available included: Thelin (sitaxsentan), Tracleer® (bosentan), Ventavis® (iloprost), Remodulin® (treprostinil) and beraprost. The data showed that the mean increase in 6MW in non-placebo trials was 75.2 +/- 40m (range: 34-148m) versus an increase of 32.3 +/- 19m (range: 15-70m) in placebo-controlled trials. The study concluded that non-placebo trials generally produce larger treatment effects than seen in placebo trials and may over-estimate treatment benefit. Placebo control arms appear necessary to properly assess treatment effectiveness in PAH. The second poster, entitled "No Clinical Interaction Between Sitaxsentan and Sildenafil" (T.C. Coyne, M.D., et al.) analyzed a 24-subject drug interaction study of Thelin and Viagra® (sildenafil) which demonstrated a minor pharmacokinetic drug-drug interaction. In the study, a group of 24 normal healthy volunteers participated in two treatment periods. In one, they received Thelin (100 mg) for seven days and a single dose of Viagra (100 mg) on the seventh day. In the other treatment period they received seven days of placebo and 100 mg of Viagra on the seventh day. Subjects were randomly assigned to which treatment they received first. Blood was drawn to determine plasma levels of Thelin, Viagra and Viagra's active metabolite n- desmethyl sildenafil. Results showed that Viagra administration did not appear to alter Thelin levels. In the presence of Thelin, the Cmax (maximum concentration) of Viagra increased by 18% and the AUC (area under the plasma concentration/time curve) increased by 28%. No effects on levels of the n- desmethyl sildenafil or blood pressure were observed. These changes are not considered clinically meaningful. Four additional Thelin posters were presented during the ATS Thematic Poster Session for Pulmonary Hypertension: -- "Sustained Efficacy with the Highly Selective Orally-Active
Endothelin-A Receptor Antagonist, Sitaxsentan, after Two Years of
Therapy in Patients with Pulmonary Arterial Hypertension" (D.
Langleben, M.D., et al.); Poster K16 -- "Sitaxsentan for Pulmonary Arterial Hypertension (PAH) Patients with
Clinical Deterioration or Significantly Abnormal Liver Function Test
on Bosentan" (A. Frost, M.D., et al.); Poster K52 -- "Sitaxsentan Treatment for Patients with Pulmonary Arterial
Hypertension (PAH) Failing Bosentan Treatment" (R. Benza, M.D., et
al.); Poster K68 -- "Do Liver Function Abnormalities with Bosentan Recur with
Sitaxsentan?" (P.C. Garces, M.D., et al.); Poster K65 About Thelin 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 the targeting of the endothelin A receptor versus the endothelin B receptor. Pulmonary arterial hypertension (PAH) is a condition that involves high blood pressure and structural changes in the walls of the pulmonary arteries, which are 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/lung or lung transplantation. PAH is estimated to afflict approximately 100,000 to 200,000 people worldwide, many of whom are children and young women. The most frequent adverse events that occurred in patients receiving Thelin, which were more common than in placebo-treated patients, were headache, edema, nausea, upper respiratory tract infection, dizziness, insomnia, nasopharyngitis, and nasal congestion. Because Thelin inhibits the metabolism of warfarin, a decreased dose of warfarin is needed when co- administered with Thelin. About Encysive Pharmaceuticals Encysive Pharmaceuticals Inc. is a biopharmaceutical company engaged in the discovery, development and commercialization of novel, synthetic, small molecule compounds to address unmet medical needs. Our research and development programs are predominantly focused on the treatment and prevention of interrelated diseases of the vascular endothelium and exploit our expertise in the area of the intravascular inflammatory process, referred to as the inflammatory cascade, and vascular diseases. We have successfully developed one FDA-approved drug, Argatroban, for the treatment of heparin-induced thrombocytopenia that is marketed by GlaxoSmithKline. Our lead drug candidate, Thelin(TM) (sitaxsentan), is an endothelin receptor antagonist that has completed final Phase III clinical trials for the treatment of pulmonary arterial hypertension. In addition, we have earlier stage clinical product candidate in development, TBC3711, a next generation endothelin receptor antagonist. 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 our estimate of the sufficiency of our existing capital resources, our ability to raise additional capital to fund cash requirements for future operations, timelines for initiating new clinical trials, planned announcements of clinical data, the possibility of obtaining regulatory approval, our ability to manufacture and sell any products, potential drug candidates, their potential therapeutic effect, market acceptance or our ability to earn a profit from sales or licenses of any drug candidate, our ability to discover new drugs in the future, and our ability to establish future collaborative arrangements. In particular, careful consideration should be given to cautionary statements made in the various reports Encysive, including as Texas Biotechnology Corporation, has filed with the Securities and Exchange Commission. Encysive undertakes no duty to update or revise these forward-looking statements. -------------------------------------------------------
Source: Encysive Pharmaceuticals Inc.
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