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CSIR India and Laxai Life Sciences initiate clinical trials of promising repurposed drug Niclosamide for treatment of Covid-19

New Delhi: CSIR in collaboration with Laxai Life Sciences Pvt. Ltd., has initiated Phase-II clinical trial with anti-helminitic drug Niclosamide for treatment of Covid-19. The trial is a multi-centric, phase-II, randomized, open-label clinical study to evaluate the efficacy, safety, and tolerability of NIclosamide for the treatment of hospitalized Covid-19 patients. Niclosamide has been extensively used in past for the treatment of tapeworm infection in adults as well as children. The safety profile of this drug has been tested over time and has been found safe for human consumption at different dose levels.

Dr. Shekhar C Mande, Director General, CSIR expressed his happiness over the SEC recommendations to conduct this Phase II clinical trial using Niclosamide, which is a generic, affordable drug and easily available in India and therefore can be made available to our population. Dr. Ram Vishwakarma, Advisor to DG-CSIR pointed out that

a) in a screen to identify drugs that can inhibit syncytia formation, Niclosamide was identified as a promising repurposed drug by a research group from King’s College, London, who collaborated in this project. The syncytia or fused cells observed in the lungs of patients with COVID-19 probably result from the fusogenic activity of the SARS-CoV-2 spike protein and Niclosamide can inhibit syncytia formation.

b) Independently, collaborative research between CSIR-IIIM, Jammu, and NCBS, Bangalore has recently demonstrated that Niclosamide is also a potential SARS-CoV2 entry inhibitor blocking the viral entry through the pH-dependent endocytic pathway. Given these two independent experimental studies, Niclosamide has now emerged as a promising drug candidate for a clinical trial in Covid-19 patients.

Dr. Srivari Chandrashekhar, Director CSIR-IICT Hyderabad, highlighted that the Active Pharmaceutical Ingredient (API) is being made by Laxai Life Sciences based on improved technology developed at IICT and the lab is a partner in this important clinical trial which could provide cost-effective therapeutic options for patients if the trial is successful.

Dr. Ram Upadhayaya, CEO, Laxai informed, that realizing the potential of Niclosamide, efforts were initiated last year itself to undertake clinical trials. Having received approval from drug regulator, the clinical trial has been initiated this week at different sites, and is expected that the trial will be completed within 8-12 weeks. Based on successful clinical evidence generated during clinical trials in Indian studies, emergency use authorization may be sought so that more treatment options are available to COVID-19 patients.

About Editor in chief

Ashok Palit has completed his graduation from Upendranath College Soro, Balasore and post graduation from Utkal University in Odia Language and literture.. He has also carved out a niche for himself as a scribe of eminence after joining the profession in 1988. He is also an independent media production professional. He brings loads of experience to Advanced Media, Ashok Palit as a cineaste has been active in film criticism for over three decades. As a film society activist, he soared to eminence for his profound commitment to the art film appreciation and aesthetics of cinema. His mode of discourse is often erudite but always lucid and comprehensible marked by a perfect acumen so rare in the field. A film aesthete with an immense fond of critical sensibilities, he wrote about growth and development of odia cinema in New Indian Express, The Times of India, The Hindustan Times, The Asian Age and Screen. He has been working as an Editor for Cine Samaya from 2002-2004.. He had made solid contribution on cinema in many odia Dailies and weekly such as Samaj, Prajatantra, Dharatri, Samaya, Satabadi, and weekly Samaya.
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