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India's drug regulatory body approves clinical trial of plant-based anti-cancer drug

Indias drug regulatory body approves clinical trial of plant-based anti-cancer drug

New Delhi (ISJ): India's federal drug regulatory body – Central Drugs Standards Control Organisation has given approval to conduct clinical trials of an anti-cancer drug using plant-based extracts.

Jammu-based Indian Institute of Integrative Medicine (IIIM), a constituent of the public-funded Council of Scientific and Industrial Research (CSIR) has found the new chemical entity effective against pancreatic cancer after successful pre-clinical trials.

"The proposed clinical trial is aimed to assess the safety, tolerability and exposure of the compound in humans along with the early efficacy indicators in pancreatic cancer patients," said CSIR.

The protein is a pure molecule natural product from the leaves of Indian White Cedar (Dysoxylum binectariferum), found in Western Ghats – mountain range parallel to western coast of the Indian peninsula.

In the last three years, researchers completed all the pre-clinical safety, regulatory and other Investigational New Drug (IND)-enabling studies, obtained global patents and published in the Journal of Medicinal Chemistry in 2018.

Pancreatic cancer currently ranks 12th among most common cancers in the world but has the notorious distinction of being the 4th leading cause of cancer-related deaths. The incidence of pancreatic cancer in India is 0.5–2.4 per 100,000 men and 0.2–1.8 per 100,000 women. Globally, it causes more than a quarter of a million deaths annually.

This cancer is considered as one of the untreatable type, because of its very late diagnosis and therefore there is huge scarcity of drugs for its treatment. This indigenous drug discovery program based on natural products opens potential therapeutic options for pancreatic cancer.


Source: Press Information Bureau

Image courtesy: Wikimedia Commons



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