Epygen Biotech, first company in India to acquire licensing of Novel Biological Entity (NBE)

Epygen Biotech recently announced a partnership with CSIR-IMTECH making it the first company in India with exclusive license of this Novel Biological Entity (NBE) thrombolytic protein for ischemic strokes. This drug will revolutionise the way Ischemic strokes are treated around the globe. CSIR transferred the technology to Epygen Biotech that would carry out pre-clinical studies and subsequently clinical trials.

Ischemic Stroke is a brain stroke, which occurs due to the blockage of an artery that supplies oxygen to the brain, is the leading cause of death and disability in the patients. An estimated 12 lakh Indians suffer from it every year.

On this partnership, Debayan Ghosh, President and Founder, Epygen Biotech said, "This is a big news in stroke management since the existing TPA based biological therapies for ischemic stroke are presented with the potential to further deteriorate the blood brain barrier (BBB) crisis triggered by the stroke itself. This revolutionary thrombolytic protein has been engineered to act accurately addressing these issues, opening up an entirely new chapter in the field of Neurology."

"Our product, PEGylated Streptokinase, has a half-life of two-eight hours because of which it can be administered 8-10 hours after an ischemic stroke. Moreover, it is inexpensive", Dr Girish Sahni, the inventor and director general of Council of Scientific and Industrial Research said.

Though the only US-FDA-approved treatment of ischemic stroke is Alteplase (recombinant tissue plasminogen activator – rtPA) prescribed for usage only up to 4.5 hours of occurrence, the Indian FDA also approves Tenecteplase, another version of rtPA for this treatment. Till date, thrombolysis with tPA remains the only approved treatment for ischemic stroke despite knowledge of the potential deleterious effects of the drug leading to hemorrhagic transformation, inducing neuronal apoptosis, disrupting blood-brain barrier (BBB), further promoting dilation of the cerebral vasculature causing the most significant morbidity and mortality in stroke patients. As per recent studies, it has been seen this drug will reduce the risk of bleeding and hemorrhage in the brain.

According to the American Stroke Association (ASA), brain strokes are the second leading cause of death in the world with a staggering 15 million people effected causing 11 million people either die or become permanently disabled. The prevalence of stroke is much higher in India than the west and about 87 per cent of all the strokes are ischemic strokes.

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