Indigenous clot busting drug gets nod for clinical trials

The first indigenous clot-busting drug to dissolve life-threatening blockages inside blood vessels of heart has now received official permission to start clinical trials within a couple of weeks.

The drug is an advanced version of “streptokinase which has been found safe during trials in monkeys. The scientists insist that it is not same as first or second generation streptokinase available in the market for clot-busting treatment.

Left untreated, blockages of blood vessels inside heart can lead to a patient’s death. Though there are drugs to dissolve these clots, they are either too expensive or have side effects like internal bleeding.

“This is a novel patented product with an additional benefit of reduced internal bleeding. It should not be equated with other commercial products. Barring a few vaccines, this is the first indigenous protein-based therapeutic, which can dissolve a clot within 30 minutes,” Girish Sahni, Director of Institute of Microbial Technology, Chandigarh, who led the research team told Deccan Herald.

The approval for phase one clinical trial came from the Drugs Controller General of India on Thursday. The trial may start in a clinical research organisation in Ahmedabad a few weeks and results will come by October.

While in the first phase, the safety of the drug will be tested on 25-30 healthy volunteers, phase II will be a multi-centric trial in which efficacy of the drug will be tested on heart patients.

The most promising clot-buster in the market is known as TPA or tissue plasminogen activator, which costs upwards of Rs 30,000 per vial in India. Commonly available streptokinase comes with a price tag of Rs 1,500-2,000 per vial.

 “The new molecule will be slightly more expensive than first or second generation streptokinase, but certainly not as costly as TPA. It will be affordable as only shot is required for each patient,” Sahni said.

Also unlike the TPA, that activates plasminogen proteins throughout the body, the new molecule is activated only after coming in contact with a blockage, making it a clot-specific streptokinase.

The drug has been licensed to a US-based firm, Nostrum Pharmaceuticals, which found it safe in test animals including monkeys. “It is promising also because it does not break apart fibrinogen and minimise the chances of recurrence,” Nirmal Mulay, chairman of Nostrum told Deccan Herald from New Jersey.

“The success comes 25 years after the Council of Scientific and Industrial Research set up a string of institutes, including IMTECH, to carry out research in frontier areas of biology. This is the first therapeutic protein molecule invented in India,” CSIR Director-General Samir K Brahmachari said.