Monday, Dec 22, 2014

Latest variant of clot-buster drug undergoes human clinical trials

At Dr Girish Sahni’s laboratory at IMTECH.  (Express) At Dr Girish Sahni’s laboratory at IMTECH. (Express)
Written by Srishti Choudhary | Chandigrah | Posted: July 21, 2014 3:31 am

Credited for indigenously developing streptokinase, a clot-buster used worldwide, Dr Girish Sahni, eminent scientist and director of the Institute of Microbial Technology, has now developed a third-generation, clot-specific variant of streptokinase. The new drug will be cheaper than streptokinase and the patient will require a single dose.

Licensed to US-based Nostrum Pharmaceuticals, the drug has entered phase-2 human clinical trial to test its efficacy on around 100 patients of heart attack. The drug has already been successfully tested on animals.

A clot-dissolving protein of bacterial origin, streptokinase is used worldwide for the treatment of diverse circulatory disorders, especially heart attack, and is on the list of World Health Organisation’s list of essential medicines.

Since the drug was manufactured in other countries, it had to be imported to India, resulting in high price for Indian consumers. Dr Sahni’s streptokinase project made the drug available in India at affordable prices.

The third generation of the drug, known as Clot-Specific Streptokinase (CSSK), will hugely reduce the side effects of currently employed clot-buster drugs which often cause bleeding during treatment.

“Several currently employed clot-buster drugs have side effects as they dissolve other clots, apart from the target clot, causing bleeding. However, CSSK is improved, safe and will be cheaper,” said Dr Sahni, adding that he was elated that the drug would address the needs of the masses at affordable prices, and the patient would require a single dose.

It is estimated that CSSK will cost around Rs 2,000 per dose, far less than the currently worldwide used tPA (tissue plasminogen activator), a clot-specific drug which costs Rs 50,000 per dose. The Council of Scientific and Industrial Research hopes to launch the drug by 2016 in the Indian market after successful completion of the trials.

The efforts of Dr Sahni date back to 2001 when the first generation of streptokinase, known as STPase, developed by his research team at IMTECH, was launched in Indian market by Cadila Pharmaceuticals Limited. That brought down the cost of the drug by 50 per cent.

Further research led to development of the second generation drug, recombinant (rDNA based) streptokinase, which was 10 times more efficient than the first generation. It was launched as Lupiflo by M/S Shasun Drugs and Chemicals Limited in the Indian market in July 2009.

A 2013 report by CSIR stated that the societal contribution by IMTECH’s research on developing indigenous methods of streptokinase production are valued at Rs 20,000 crore, as the different drugs emerged from the technologies contribute around 40-50 per cent of the total market share of streptokinase in India.

“The research conducted by a scientist in the laboratories has to essentially reach the industries and bring benefits to society at large. Patents and transfer of technology — that is the ideal combination for a scientist,” smiled Dr Sahni, highlighting the need for application-based research.

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