Clot-specific Streptokinase (CSSK), a pioneering biotherapeutic clot buster drug from the CSIR's Institute of Microbial Technology (CSIR-IMTECH), has been cleared yesterday by the Drugs Controller General of India (DCGI) for Phase-One Human Clinical trials, an official statement said.
The Chandigarh-based CSIR-IMTECH had licensed the drug to US-based Nostrum Pharmaceuticals in a multi-million dollar deal, a statement from Council of Scientific and Industrial Research (CSIR) said.
CSSK, designed by a team led by IMTECH Director Girish Sahni, has been found to be safe in test animals including monkeys. Also, CSSK has already been shown to be efficacious in dissolving the blood clots in monkeys.
CSSK is the first in India-patented biopharmaceutical therapeutic protein that will help save the lives of patients of heart attacks, the CSIR said.
It added that the drug is also expected to exhibit greatly reduced side-effects, such as internal bleeding often associated with the use of clot busters.
"CSIR's achievement in developing a series of clot buster drugs is remarkable as it covers the whole 'inventor/innovation' chain from economically robust process development to obtain affordable modern drugs, on the one hand, and to internationally competitive blockbusters, on the other," CSIR Director General Samir K Brahmachari said.
