The recent decision of the Drug Controller General of India (DCGI) to grant permission for phase-2 clinical trials for clot specific streptokinase (CSSK) is a major step forward in testing the efficacy of this lifesaving drug for heart patients Â a first of its kind in the Country (patented new biopharmaceutical molecule).
Phase two of clinical trials is carried out to test the efficacy and side effect of the drugs on human beings.
CSSK was discovered in the Chandigarh-based Institute of Microbial Technology, a national laboratory of Council for Scientific and Industrial Research (CSIR). A US based pharmaceuticals company Nostrum Pharmaceutical LLC subsequently acquired rights from CSIR for further clinical development of this drug.
This is being described as an excellent example of `Make in IndiaÂ and paves the way for more foreign collaborations for use of indigenous technology Research and Development in the pharmaceutical sector in the future overcoming the general perception of red-tapism in India.
This drug and its associated protein engineering technology was discovered and developed at CSIR-IMTECH, Chandigarh, by the R&D group of Dr. Girish Sahni, who was Director of the Institute and is now the Director General of CSIR and Secretary, DSIR, Government of India.
CSSK is a novel biotherapeutic molecule that has been generated by a recombinant DNA and protein engineering technologies with a innovative clot busting function, and will be used to treat acute myocardial infarction (heart attack). At the pre-clinical level, the drug has been successfully tested on monkeys where it has established, among other things, animal toxicity. Similar tests have been performed successfully on rats and mouse.
In the first phase of clinical trials, CSSK was successfully tested for safety and tolerability in healthy human volunteers. The current approval from DCGI to continue further clinical development of this molecule under on-going Phase II on heart attack patients will help define the precise therapeutic dose of CSSK needed in a phase III setting.
Congratulating Nostrum Pharmaceuticals for the progress so far, Dr Girish Sahni, DG, CSIR and Secretary, DSIR hoped that the current approval would help the company take the project forward in an expedited manner. He said ÂNostrum has shown commitment towards developing this molecule for. Clinical application and regulatory approval, and the success achieved so far has nurtured the hope of successfully developing IndiaÂs first ever patented new biopharmaceutical molecule, which will help save lives of cardiac patients all over the countryÂ.
According to Dr. Anil Koul CSSK is an excellent example of translational medical research carried out at CSIR-IMTECH and hopes that this success would continue to inspire scientists not only in the CSIR institutes but across the country to orient their research towards fulfilling unmet needs in the area of drug discovery and development.
Dr. Nirmal Mulye, President of Nostrum Pharmaceuticals LLC of Somerset, New Jersey, USA thanked CSIR-IMTECH and the role of Dr. Sahni and his teal all throughout the years for their support iim the on-going project. He said ÂWe are glad at receiving this approval from DCGI and also thankful to CSIR-IMTECH for their unstinted support. Ours is a great example of a public-private partnership that has resulted in the development of a new bio therapeutic drug molecule which will address a very critical need of the patients across the country especially for those belonging to the poorer sections of the societyÂ.
Four generations of Streptokinase were developed in CSIR-IMTECH by Dr.Girish Sahni. Two of these drugs i.e. the first two generations of bio generics were licensed and were successfully commercialized. They account for 50% of market share of clot busters in the country.
This success story from CSIR is a true example of cutting edge basic research leading to impactful translational research, creating a portfolio of drug molecules, a couple of which were successfully commercialised and the others are on the path of emerging as the global first.