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Clot-Busting Drug THR-100 (Staphylokinase) Enters Phase III Clinical Trials in India
Published on February 4, 2011
Hyderabad :Bharat Biotech (www.bharatbiotech.com) today announced it has initiated a Phase III trial in India with THR-100 in patients suffering an acute myocardial infarction (AMI or heart attack). Bharat Biotech is a leading innovator and manufacturer of vaccines and biologics with focus on emerging markets. The trial is expected to recruit approximately 120 patients.
Bharat Biotech entered into a license agreement with ThromboGenics for the manufacture, clinical development and commercialization of THR-100 with the objective of potentially commercializing THR-100 as a replacement for establishedthrombolytics, such as streptokinase and urokinase, in developing markets in December 2006. 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 this novel thrombolytic to be filed for marketing approval by Bharat Biotech with Indian regulatory authorities.
