CSIR developed biopharma drug enters phase-2 clinical trials

The Clot Specific Streptokinase (CSSK), a novel patented thrombolytic biopharmaceutical therapeutic protein drug licensed from the CSIR-Institute of Microbial Technology (CSIR-IMTECH), Chandigarh, a constituent institute of the Council of Scientific and Industrial Research (CSIR), has received permission from the Drugs Controller General of India (DGCI) to conduct phase-2 human clinical trial to test the efficacy of CSSK in the patients of heart attack, a condition known as Acute Myocardial Infarction. Symmetrix Biotech Pvt Ltd has been carrying out the clinical development of CSSK, also known as SMRX-11.
 
“This has been the culmination of seven years of long and meticulously carried out developmental process of this molecule under a unique and successful public-private partnership between CSIR-IMTECH and Nostrum Pharmaceuticals of the US (the parent company of Symmetrix Biotech Pvt Ltd),” said Dr Girish Sahni, Director, CSIR-IMTECH and innovator of this molecule.
 
Dr Sahni emphasised that the CSSK is unique 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. Besides being safe and effective, CSSK would also be a much cheaper and affordable alternative to the currently available expensive thrombolytic drugs and will thus address the needs of the larger masses of the country, he added.
 
Earlier, in July 2006, CSIR-IMTECH had licensed CSSK to Nostrum Pharmaceuticals of the US for clinical development through its Indian subsidiary, Symmetrix Biotech Pvt Ltd.
 
Dr Nirmal Mulye, President of Nostrum Pharmaceuticals, LLC, New Jersey, USA said, “It is a proud moment both for his company and CSIR-IMTECH. CSSK development has come a long way since we licensed the molecule in July 2006. It is now on the threshold of success since we have already seen a successful efficacy in cynomolgus monkeys and a very safe profile of tolerability, pharmacokinetics and pharmacodynamics in healthy human volunteers. We will very soon be embarking on the Phase-2 clinical trial following the recently obtained permission from DCGI.”