Phase-II trials for new clot buster drug approved

Bio-therapeutic drug, Clot Specific Streptokinase, meant for patients who suffer heat attack, was developed using bacteria

 
By Jyotsna Singh
Last Updated: Saturday 04 July 2015

The Drugs Controller General of India has permitted phase-II clinical trials to test the efficacy of a life-saving drug for patients of heart attack. The drug molecule has been tested on animals and healthy humans. In phase-II, it will be tried on patients. The clot buster has been prepared by Chandigarh-based Institute of Microbial Technology (IMTECH) of the Council of Scientific & Industrial Research.

If this phase succeeds, phase-III trials will be conducted on a larger sample of human patients. The institute has already filed for patent for the drug.

Clot Specific Streptokinase (CSSK) is a bio-therapeutic drug, developed using bacteria. It is third generation drug to fight clot formation in veins of heart, a condition responsible for heart attacks. The earlier two drugs developed by IMTECH had side effects and had to be administered slowly through intra-venous therapy. The new drug attacks directly at the clot and can be administered through normal syringe. Thus, the infrastructure needed would be much less and outcomes better.

Similar therapy available in India currently is tissue plasminogen activator (tPA) which is also a bio-therapeutic drug, but uses human tissue. It functions the same way and costs around Rs 50,000 per injection. "CSSK will, on the other hand, cost a couple thousand only," said Girish Sahni, director, IMTECH.

If everything goes fine, the product is expected to be out in the market by 2016. IMTECH is is carrying out the project in collaboration with Nostrum Pharmaceuticals which will be responsible for conducting clinical trials and bringing finished product to the market.

"We have been working for 12 years on this innovation," said Sahni.

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