Texas Biotechnology Corp. has launched a multi-center Phase II/IIItrial in the U.S. of Novastan, the Houston-based company's leadproduct, as a replacement for heparin, which is the standardanticoagulant used in post-surgical coronary therapy.
Among the side effects of heparin is an immune system reaction,triggered by a reduction in platelet counts, that in its most severeform causes blood clots in some patients. The conditions are knownas heparin-induced thrombocytopenia (HIT) and heparin-inducedthrombocytopenia thrombosis syndrome (HITTS).
The Novastan trials will test Texas Biotechnology's product as aalternative for heparin in 200 to 300 patients who are in danger ofdeveloping either HIT or HITTS during post-surgical coronarytreatment. The studies will be conducted at 55 medical centers in theU.S. and Canada and results are expected in late 1996.
Novastan is a small molecule drug derived from an amino acid, calledL-arginine, which inhibits thrombin, an enzyme involved in bloodclotting.
Joseph Welch, Texas Biotechnology's vice president of businessdevelopment, said earlier Phase I and Phase II studies have shownthat when compared with heparin, "Novastan has a favorable clinicalprofile in terms of an ability to fine-tune the anticoagulation effect."
Welch said that each year in the U.S. and Canada about 300,000post-surgical coronary patients develop HIT or HITTS.
He added that Texas Biotechnology also will be conducting trials ofNovastan as a substitute for heparin in conjunction with thrombolyticagents to treat heart attacks. _ Charles Craig
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