Texas Biotechnology Inc., whose lead product is a small moleculecompound being developed as a heparin substitute, began a Phase IIItrial of the thrombin inhibitor, Novastan, for patients undergoingangioplasty and other coronary interventions.
The studies are an attempt to broaden applications of Novastan. Thedrug is in clinical development for patients who are allergic toheparin, the standard anticoagulant used in coronary procedures.
A 300-patient Phase III trial of Novastan already is under way forpost-surgical therapy in patients at risk of developing heparin-induced thrombocytopenia (HIT) and heparin-inducedthrombocytopenia thrombosis syndrome (HITTS).
The new Phase III study will enroll 30 patients with HIT and HITTS.In addition to testing Novastan's anticoagulation capabilities, anotherprimary endpoint for the trial will be the drug's effect on success ofthe angioplasty procedures.
Novastan also is being evaluated in Phase II trials in combinationwith thrombolytics for treatment of heart attacks.
Novastan, whose generic name is argatroban, is a small moleculederived from an amino acid called L-arginine, which inhibitsthrombin, an enzyme involved in blood clotting.
Texas Biotechnology expects to file a new drug application with theFDA by mid-1997 for Novastan. The company licensed U.S. andCanadian rights to the compound from Genentech Inc., of South SanFrancisco. Mitsubishi Chemical Corp., of Tokyo, markets the drug inJapan for chronic arterial occlusions.
About 300,000 coronary patients a year are affected by HIT orHITTS.
Texas Biotechnology's stock (AMEX:TXB) closed Friday at $5.06,down 25 cents. n
-- Charles Craig
(c) 1997 American Health Consultants. All rights reserved.