Hyderabad-based biopharmaceutical company Bharat Biotech International Limited (BBIL) announced that it had initiated Phase III trial of THR-100 in India in patients suffering from acute myocardial infarction (AMI or heart attack).
The company intends to recruit about 120 patients for the trial that is expected to be completed in the second half of 2011. The global market size for the vaccine is estimated to be around $1 billion.
In December 2006, BBIL entered into a license agreement with ThromboGenics, a Belgium-based biopharmaceutical company, for the manufacture, clinical development and commercialisation of the new vaccine.
THR-100 is being developed as a replacement for established thrombolytics, such as streptokinase and urokinase, in developing markets. It is a novel variant of Recombinant Staphylokinase, a thrombolytic agent developed by ThromboGenics for the treatment of AMI and other vascular diseases, based on its ability to dissolve blood clots.
The results of the Phase III trial will pave the way for the vaccine to be filed for marketing approval with Indian regulatory authorities, it said.