Mumbai: Piramal Life Sciences, which has developed a molecule P276 for the treatment of head and neck cancer, will shortly begin the second phase of clinical trials for the product in India.
“This week, we will start the Phase two clinical trial of our head and neck cancer molecule following the Drug Controller’s approval,” Piramal Life Sciences Executive Director Swati Piramal said.
The molecule has undergone successful Phase one clinical trial in Canada. Phase one trial is the first stage of testing in humans. This phase includes trials designed to assess the safety and tolerability of a drug.
Phase two trial is performed on a larger group and are designed to assess how well the drug works at the same time to continue Phase one safety assessments on a larger group of volunteers and patients.
“We have been ready since February to start Phase 2 trial, but the go ahead came just now,” Piramal said.
In developed countries, approvals come in 28 days, she said, adding here it has taken six months.