New Delhi: In what could be a potential prospective drug for ischemic stroke, scientists at Council of Scientific and Industrial Research (CSIR) have developed a new clot-buster which has been licensed out to a Mumbai-based bio-pharmaceutical company for conducting drug trials.
The new clot-buster, PEGylated Streptokinase-a Novel Biological Entity has been developed by Dr. Girish Sahni, director general, CSIR and his research team at CSIR-Institute of Microbial Technology (CSIR-IMTECH), Chandigarh who have been working on clot-busters for over two decades.
IMTECH has signed an agreement with Epygen Biotech Private Limited, Mumbai, which will be the first company in India with exclusive license to develop this patented PEGylated Streptokinase for treatment of ischemic stroke. The transfer of technology will be followed by several stages of drug development process including toxicity studies and clinical trials.
“PEGylated Streptokinase has an extended half-life so it remains in blood longer than the currently administered tPA (tissue plasminogen activator), which is crucial for a patient of stroke. It has associated clot-specificity and reduced immuno-reactivity, so there is a reduced probability of bleeding over current treatment regimens of drugs for acute stroke. Our preliminary studies done in animals have shown positive results," said Dr Sahni whose laboratory is credited for developing the first generic technology for clot-busters in the country at an affordable price.
Currently tPA is considered the best treatment available for patients of stroke, which has become a global health concern. In India, at least 28% (0.4 million) out of 1.3 million cardiovascular deaths in the age group from 30 to 69 years are caused by stroke, according to a recent Lancet Global Health report.
However, a dose of tPA costs at least ₹ 40,000 necessitating the need for an affordable drug, which led Dr Sahni and his team to precisely engineer a clot-specific Streptokinase which has potential to transform the way ischemic strokes are treated especially in the developing world.
TPA also suffers from certain problem sequences and has to be administered within three hours of stroke, after which it becomes counter-productive. However, administering Streptokinase involves no such risk of exacerbating the situation.
“The world needs affordable medicines and this would be affordable. It is no wild optimism, but hope based on early-stage evaluation. It will undergo several stages of drug-development which could last for six to ten years and we believe that it has potential because there is a real vacuum for stroke medicines in the world. We will work together to develop it," said the CSIR-DG.
Ischemic stroke is caused by blockage the supply of oxygenated blood to the brain due to a clot in cerebral blood vessels resulting in tissue death. According to the American Stroke Association (ASA), about 87 per cent of all strokes are ischemic strokes.