New Delhi, Aug. 17: A clot-busting protein molecule designed by government scientists for use in the treatment of heart attacks has become India’s first home-grown “bio-therapeutic molecule” to be approved for human clinical trials, the scientists claimed today.
The Drugs Controller General of India yesterday approved human safety studies, called phase I trials, of the protein that scientists expect will have lower levels of side effects compared to the conventional clot-busting drug streptokinase.
The protein, developed more than six years ago by scientists at the Council of Scientific and Industrial Research (CSIR) and Institute of Microbial Technology (IMTECH), Chandigarh, has already been tested on rats, dogs, and monkeys, IMTECH director Girish Sahni said.
IMTECH’s patented molecule is a hybrid protein. It combines streptokinase with a natural protein from human blood and executes its clot-busting action only when it encounters blood clots and not while swimming elsewhere in the bloodstream.
While clot-busters rapidly dissolve clots that obstruct flow in blood vessels, they generally carry a risk of bleeding. The clot-specific streptokinase from IMTECH is expected to exhibit reduced levels of side effects because it remains inactive when it doesn’t see clots.
In the phase I study, the molecule will be administered to a small group of healthy human volunteers, perhaps about 10 people, to determine its safety. If it is shown as safe, scientists plan to conduct phase II and phase III, efficacy studies to determine if it can actually help patients who’ve had heart attacks.
Phase II and phase III are critical steps in the process of evaluating a new drug in which the new product has to be typically shown as both effective and superior to other drugs already in commercial use.
“If all goes according to plan, we expect this clot-specific streptokinase to be ready for commercial use by the end of 2014,” Sahni said.
CSIR’s director general Samir Brahmachari said IMTECH’s research on clot-busting drugs represents the complete innovation chain — from basic design work in the lab to technology transfer and drug evaluation.
US-based company Nostrum Pharmaceuticals had in 2006 acquired the global rights for the commercialisation of the clot-specific streptokinase developed by Sahni and his colleagues. The molecules used for tests continue to be developed at IMTECH.