#GS3 #Health #Research&Development #Science&Technology
CSIR constituent lab CSIR-Indian Institute of Integrative Medicine (IIIM) Jammu, has received Investigational New Drug (IND) approval from New Drugs Division of Central Drugs Standard Control Organization (CDSCO) for a potent anti-cancer, New Chemical Entity (NCE) effective against pancreatic cancer after successful completion of preclinical development and IND submission.
- This will pave way for CSIR- IIIM for conducting the clinical trial of this important drug candidate IIIM-290 in pancreatic cancer patients.
- 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.
- This drug was discovered and developed at the natural-products driven drug discovery program of CSIR-IIIM.
- Dr Ram Vishwakarma, highlighting the R&D carried out, informed that the anti-cancer screening against NCI-60 cancer cell lines panel and clinically validated protein kinase enzymes involved in cancer provided in 2011, provided an initial potent hit (rohitukine, a pure molecule natural product from the leaves of a tree from the Western Ghats Dysoxylum binectariferum,commonly known as Indian white cedar).
- Further medicinal chemistry designed to address efficacy/selectivity against a class of cell-cycle regulatory kinases (i.e. cyclin-dependent kinases) identified this preclinical candidate IIIM-290 showing excellent pharmacokinetics, oral bioavailability and potent anticancer activity in a number of animal xenograft models, with the best activity against the pancreatic cancer model.
- In the last three years, researchers completed all the pre-clinical safety, regulatory and other IND enabling studies, obtained global patents and published in, the Journal of Medicinal Chemistry in 2018.
- Pertinently, the 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 cancer type, because of its very late diagnosis and therefore there is a huge scarcity of drugs for the treatment of this cancer.
- This indigenous drug discovery program based on natural products opens potential therapeutic options for pancreatic cancer.