New Delhi (ISJ): A state-run lab has received clearance from the national drug watchdog, to conduct phase 2 human trials of a novel drug to treat heart attacks caused by blood clotting. The drug named, Clot Specific Streptokinase (CSSK) has reduced side-effects when administered to patients suffering heart attacks, unlike currently available clot busting drugs.
Developed by Chandigarh-based Institute of Microbial Technology (IMTECH) under Council of Scientific and Industrial Research (CSIR), CSSK is the first patented biopharmaceutical drug developed in India.
The second phase of human trials will test its efficacy in patients of heart attack for a condition known as Acute Myocardial Infarction. This was announced by Dr. T. Ramaswami, Secretary, Department of Science and Technology and Director General of CSIR in New Delhi.
During the initial clinical trials, the drug was administered to healthy human volunteers, with no sign of any adverse effect. Clot buster therapies with streptokinase often cause increased internal bleeding and fatalities.
"This has been an exemplary and diligent pursuit of translational science from lab to the very threshold of clinic,"said Dr. Ramaswami, addressing the media.
IMTECH has licensed the drug to US-based pharma major Nostrum Pharmaceuticals for clinical development through its Indian subsidiary Symmetrix Biotech Pvt Ltd.
"This is the culmination of seven years of meticulously carried out developmental process of this molecule under a unique and successful public-private partnership between CSIR-IMTECH and Nostrum Pharmaceuticals," said Dr. Girish Sahni, Director of IMTECH.
Dr. Sahni said a maximum dose of upto 20 CSSK was given to volunteers, who showed no adverse effects and their blood fibrinogen levels remained unchanged. He said the drug has been successfully demonstrated in monkeys, where it was shown to dissolve newly created blood clots.
The drug will be tested to a larger number of patients in the next phase of trials by the end of this year. It is expected to hit the market by 2015 end and will be India's answer to the more expensive thrombolytic agents such as tPA.