Bharat Biotech begins phase III trials of clot-busting drug
By IANSFriday, February 4, 2011
HYDERABAD - Bharat Biotech (www.bharatbiotech.com) Friday announced that it has initiated Phase III clinical trials in India of THR-100 (Staphylokinase), a clot-busting drug for patients suffering an acute myocardial infarction (AMI).
The trial is expected to recruit approximately 120 patients, said a statement by Hyderabad-based Bharat Biotech, a leading vaccine manufacturer.
Bharat Biotech entered into a license agreement in 2006 with ThromboGenics for the manufacture, clinical development and commercialization of THR-100 as a replacement for established thrombolytics, such as streptokinase and urokinase.
THR-100, a novel variant of Recombinant Staphylokinase, is a thrombolytic agent developed by ThromboGenics for the treatment of AMI and other vascular diseases, based on its ability to dissolve blood clots.
Bharat Biotech anticipates that the Phase III trial with THR-100 will be completed in the second half of 2011. The results of this Phase III trial will pave the way for thrombolytic to be filed for marketing approval by Bharat Biotech with Indian regulatory authorities.
