Kolkata: Kolkata’s homegrown clinical research start-up Clinimed Lifesciences claims to have come up with a patented natural product---basically a wheat plant-based compound--to cure thalassemia, a blood disorder. The trial is nearly complete and the commercial launch is expected in the next two-to-three months, said Dr. Swati Dasgupta, Co-Founder and Joint Director (Clinical Operation), Clinimen Lifesciences.
She said her contract research organisation (CRO) that provides clinical research services on a global scale had done successful trial tests on mice and then human bodies.
Dr. Dasgupta said the final approval from the Ayush Ministry for the product’s commercial launch is expected any day now, though approval from the United States Food and Drug Administration could take up to eight months. Since the product is derived from a wheat compound, Clinimen can launch the product in India once the go-ahead comes from the Ayush Ministry, she said.
Interestingly, Clinimed has also conducted Phase-1 clinical study of metastatic colorectal cancer and it has screened 58 per cent patients--among them 76 per cent are randomized--in a global scale and became the highest recruiter from India for the study. The results have been submitted to the US FDA. She said Clinimed, being a global scale CRO, ensures that a global trial will moves faster to market. Clinimen, she said, has a record of ‘screen failures’ of below 3.5 per cent on an average.
Dr. Dasgupta said the company is continuously testing new anti-microbial activities of new drugs and analysing different microbiological activities of molecules by various techniques. The main objective is to develop new therapeutic drugs for threatened diseases such as cancer.
“We have a different ‘apoptotic pathway’ for establishment of new drugs by Invitro Cell Culture method and we practise Invio Mice Model to study the exact immunological status and toxicity level of a particular drug on animal body. Currently, we are developing monoclonal antibodies which target various proteins that influence cell activity such as receptors or other proteins present on the surface of normal/cancer cells, which will help create a new era of treatment strategy,” said Dr. Dasgupta.
Clinimen is currently preparing a new drug as a syrup for iron overloaded patients, applying aurvedic procedure, which will be a large-scale production of its own, said Dr. Priyabrata Das, Joint Director (Clinical Operation).
The research company has recently been listed among the top 20 CRO companies by BioSpectram, an Asia-Pacific publisher, for 2019 and has also tied up with Netaji Subash Chandra Bose Cancer Hospital’s research laboratory for testing of new molecules.
