Piramal Healthcare gets approval from DCGI
Mumbai, Jul 20 : Piramal Healthcare Limited announced today it has received approval from the Drug Controller General of India (DCGI) for conducting the Phase II clinical trial of P276 in combination with chemoradiation for the reduction of serious radiation-induced mucositis in patients of head and neck cancer.
Phase I studies were completed in Canada and India. The drug is likely to reach Phase III in early 2013.
The DCGI decision to allow us to proceed with this study in collaboration with many expert investigators throughout India will be of great benefit to patients of head and neck cancer.
Radiation Induced Mucositis (RIM) is a common and painful side effect of radiation and chemoradiation in head and neck cancer patients.
Serious radiation induced mucositis (RIM) occurs in 40-65 per cent of all patients who receive radiation courses for head and neck cancers.
Prevalence of Head and Neck cancer in India is amongst the highest in the world. Even within India, this cancer is common with roughly 150,000 to 200,000 cases identified each year.
Symptoms of RIM include soreness of the mouth and throat that often progresses to severe pain, difficulty or inability to swallow due to open oral lesions, a release said.