Piramal Healthcare gets nod from DCGI for conducting Phase II clinical trial of P276-00

20 Jul 2012 Evaluate

Piramal Healthcare 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. 

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.

 P276-00 is a new chemical entity (NCE), a cyclin dependent kinase complex which plays an important role in the regulation of cell cycle progression. It also has demonstrated anti-inflammatory properties by virtue of its ability to inhibit TNF-α. Combination studies of P276-00 are in progress in patients with pancreatic cancer and Triple Negative breast cancer. 

Piramal Healthcare is an innovation led company with a growth track record of above 25% CAGR since 1988. Piramal, had consolidated revenues of $450 million in FY2012. With assets across North America, Europe and Asia, Piramal Healthcare is one of the largest pharmaceutical custom manufacturing companies across the world. It has significant presence in the global critical care space with sales of anesthesia products to over 100 countries.

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