The drug, expected to be launched in the market by 2016, has been cleared for phase II human clinic trial, said Dr. Girish Sahni, director of Council for Scientific and Industrial Research-Institute of Microbial Technology. (Agencies)
He described it as a third generation improved clot buster which is a result of seven years of developmental process under a public-private partnership between CSIR-IMTECH and Nostrum Pharmaceuticals of the US.
The drug -- the clot specific streptokinase (CSSK) – has been patented and has received permission from the Drugs Controller General of India to conduct phase II trial on 75-80 patients.
"Normally heart attack happens when clot forms in the blood vessels giving blood to the heart muscle. You put in clot busters to dissolve the blood. This molecule (drug) will be given as a single injection instead of infusion over a period of one hour," he told reporters.
On its launch, the drug could come at Rs 2000-Rs 3000, less than half the price of what is available in the market, he said.
This is a unique drug in that it has a hugely reduced risk of bleeding during the treatment, which makes it a distinctively improved drug compared to several currently employed thrombolytic drugs where the risk of bleeding exists to varying degrees, he added.
According to Sahni, the successful phase-1 clinical trial demonstrated the safety of CSSK which was given as a single bolus dose to healthy human volunteers who tolerated the drug very well with no adverse effects otherwise sometimes observed in a clot buster therapy such as increased risk of internal bleeding due to a drop in blood-fibrinogen levels.
Symmetrix Biotech is carrying out the clinical development of CSSK.
"CSSK is expected to be a leading thrombolytic drug worldwide upon successful clinical development," a statement from the department of Science and Technology said.
The drug, expected to be launched in the market by 2016, has been cleared for phase II human clinic trial, said Dr. Girish Sahni, director of Council for Scientific and Industrial Research-Institute of Microbial Technology.