Nicholas Piramal gets FDA okay for cancer drug trials

MUMBAI: Domestic pharma major Nicholas Piramal announced on Monday that it had received approval from the USFDA to start clinical trials on humans for its new cancer drug. This is Nicholas Piramal’s first Investigational New Drug (IND) application, and the first new cancer drug developed by an Indian company, to be approved by the US FDA for clinical trials.

Phases I/II of clinical trials — studies aimed at testing the drug’s safety and efficacy — will start shortly at Harvard University’s Dana Farber Cancer Institute in the US. Two additional sites, New York’s Saint Vincent’s Hospital and Emory University Medical Center in Atlanta, will also participate in this study.

“This is a tribute to Nicholas Piramal’s research, especially when this drug is targeted at a life-threatening disease such as Multiple Myeloma, and our application would have therefore been examined with a lot of care,” said Dr Swati Piramal, director, strategic alliances. Nicholas Piramal is developing this new drug to treat Multiple Myeloma.

Nicholas Piramal’s new anti-cancer drug is currently undergoing phase I/II clinical trials in Canada and India. The company is also working on a highly-potent antibiotic drug candidate — active against methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE) — as well as on two herbal drugs in phase II of clinical development, targeted at inflammation and infectious diseases.