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Piramal Life Sciences Limited, part of the Piramal Group of companies, has received regulatory approval from the Drug Controller General of India (DCGI) for starting phase-I/II combination studies of its cancer molecule P276 for pancreatic, and head and neck cancer. The study aims at identifying the right doses of P276 to be used in combination with chemotherapeutic drugs, and evaluating the therapeutic benefit of the combination of drugs in pancreatic, and head and neck cancer patients, the company said in a statement. More than 2,00,000 cases of neck and head cancer are diagnosed in India and worldwide respectively, the company said. ''Pancreatic cancer is a deadly disease with more than 37,000 new cases diagnosed in United States in 2007. There were 33,000 deaths attributed to this disease in USA in 2007. Surgery and conventional chemotherapy are the only options for these patients with very limited benefit and number of serious side effects,'' the release said. ''The conventional treatment for head and neck cancer is chemotherapy and radiation as the first line therapy or as chemotherapy after surgery. These treatments are associated with unwanted side effects,'' it said. In order to have a safe and effective treatment, there is a need for combining the conventional chemotherapy with a safe and targeted agent such as P276, the release pointed out. P276 is an inhibitor of key enzymes involved in the uncontrolled division and multiplication of cancer cells. It is being developed for the treatment of cancers for which there are inadequate treatment options. "This regulatory approval will enable us to initiate two additional clinical trials for our lead cancer molecule. As a result, P276 will be studied in five different clinical studies for cancers for which new treatments are still needed,'' Piramal Group director Swati Piramal said. ''We are also conducting such studies in other countries such as the US and Australia. The total investment on these studies will be about Rs5-10 crore,'' she added.
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