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Biotech / Medical : Indications -- cardiovascular
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To: scaram(o)uche who started this subject3/30/2004 7:58:48 AM
From: nigel bates  Read Replies (1) of 214
 
Vernalis V10153 (thrombin-activatable plasminogen) - Phase IIa study completed

From toady's results announcement

V10153 (formerly BB-10153) is a novel recombinant thrombolytic protein targeted at thrombotic disorders. It has been evaluated by the US TIMI Study Group in a Phase IIa ascending dose study to establish proof-of-concept (i.e. that it can dissolve clots and restore coronary bloodflow) in patients who have suffered acute myocardial infarction (AMI). The study also evaluated the safety of treatment with V10153, especially with respect to bleeding.

The study has now been successfully completed. V10153 was well tolerated throughout the dose range of 1-10 mg/kg to patients with AMI. Full restoration of bloodflow was observed in blocked coronary arteries in around 40 per cent of patients after 60 minutes following doses of 5 mg/kg and greater. This is comparable to the efficacy reported for other marketed thrombolytic therapies using a similar experimental protocol. Initial analysis of safety (episodes of bleeding) is encouraging with no spontaneous bleeds.

The next stage in development of V10153 is to conduct a Phase II study in approximately 100 patients with acute stroke. Vernalis is currently evaluating whether to undertake this study itself or wait until a collaboration has been secured...
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