Usha Sharma – Mumbai
The Institute of Microbial Technology (IMTECH), one of the national laboratories of the Council of Scientific & Industrial Research (CSIR) which recently received the Drugs Controller General of India (DCGI)’s nod for phase I trials for its clot buster drug is due to kick off the trial by end October at Veeda Clinical Research (Veeda CR), an Ahmedabad-headquartered CRO.
The drug is likely to be launched in the Indian market by 2014.
In an interaction with Express Pharma, Dr Girish Sahni, Director, CSIR-IMTECH, Chandigarh said, “It took almost six to eight months to get the final nod from DCGI for conducting human phase I clinical trials. We have generated the data as per the requirements by the DCGI’s office and the entire process was fairly efficient.”
The molecule to go to trial is a clot-specific streptokinase (CSSK), a pioneering biotherapeutic clot buster drug from CSIR-IMTECH which was earlier licensed to Nostrum Pharmaceuticals LLC, a New Brunswick, New Jersey- based firm. This drug has been successfully tested in animals including monkeys and the scale-up was achieved by a team led by Sahni.
Sahni’s area of expertise is engineering of therapeutic proteins and the mechanism of action of enzymes. Successful technologies developed by Sahni’s group at IMTECH include a complete high-efficiency process package for production of natural streptokinase for the first time in India, resuting in the launch of ‘STPase’ by Ahmedabad-based Cadila Pharma in 2002. The Chennai-based Shasun Drugs and Chemicals was the second beneficiary of the group’s expertise, when they successfully transferred the production process for recombinant (rDNA-based) streptokinase production. The product, Lupiflo, was launched in the Indian market in July 2009.
On November 24, 2010, Nostrum Pharmaceuticals entered an in-licensing agreement with IMTECH for clinical development and worldwide commercialisation of next generation thrombolytics discovered at IMTECH.
The protein-engineered, therapeutically improved “clot-specific” streptokinase that was licensed to Nostrum Pharma and Symmetrix Biotech, India is a modified molecule, which reduces the side effects associated with clot buster bleeding, reveals Sahni. The phase-I trial is likely to be conducted on 10-20 healthy human volunteers in order to check the efficacy of the molecule.
Commenting on this achievement, Samir K Brahmachari, Director General, CSIR, said, “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 to internationally competitive blockbusters.
At the time, Dr Nirmal Mulye, President. Nostrum Pharmaceuticals, had said that this was an unprecedented example of a successful public-private partnership in India and thanked CSIR-IMTECH for being part of the project by providing the infrastructure for the biopharma manufacturing process development for CSSK.
IMTECH’s CSSK candidate is being hailed as the first India-patented (non-generic) biopharmaceutical (therapeutic protein). It is hoped that the trial molecule will not only help to save the lives of patients prone to heart attacks, but will also exhibit reduced side-effects, such as internal bleeding often associated with the use of clot busters. The successful development of state-of-the-art bio-therapeutic drugs such as CSSK marks a major milestone for the Indian biotech science community, which has already gained recognition for smart and economic processes for bio-similars, an area in which CSIR-IMTECH has already contributed significantly by developing two clot busters (natural and recombinant streptokinase), which are already selling well in the market.