Piramal Healthcare Limited announced that it has received approval from the Drug Controller General of India (DCGI) for conducting the Phase II  clinical trial of P276-00 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.

Commenting on the development, Dr. Alan Hatfield, Executive Vice President, Clinical Research, Piramal Healthcare said “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% 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. The consequences of RIM are far-reaching leading to increased medical resource use, patient suffering and poor outcomes of therapy.  Radiation induced mucositis remains a high unmet medical need as to date, no agent has been approved for the indication of serious radiation induced mucositis in Head & Neck Cancer patients.

Dr. Swati Piramal, Vice Chairperson, Piramal Healthcare stated, “Severe radiation induced mucositis is a debilitating toxicity of chemoradiation in head and neck cancer patients and can limit the treatment dosing and frequency.  By developing P276 for the treatment of radiation induced mucositis, we hope to provide benefit to patients both clinically, and in terms of a better quality of life, thereby addressing this unmet medical need.”