Pancreatic cancer is a deadly disease with more than 37,000 new cases diagnosed in United States in 2007.
Piramal Life Sciences has received regulatory approval by Drug Controller General of India (DCGI) for the initiation of two phase-I / II combination studies of it's cancer molecule P276 for pancreatic, and head and neck cancer. The objectives of both studies are (1) to identify right doses of P276 to be used in combination with chemotherapeutic drugs, and (2) to evaluate the therapeutic benefit of the combination of drugs in pancreatic, and head and neck cancer patients.
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. Thus, pancreatic cancer remains an incurable disease. Similarly, for head and neck cancer, more than 200,000 (most common cancer in India) and 600,000 new cases are diagnosed each year in India and worldwide respectively. The conventional treatment for head and neck cancer is chemotherapy and radiation as first line therapy, or as chemotherapy after surgery. These treatments are associated with unwanted side effects. Therefore, in order to have a safe and effective therapy there is a need for combining the conventional chemotherapy with a safe and targeted agent such as P276. For pancreatic cancer, P276 will be combined with Gemcitabine (which is already approved for the treatment of pancreatic cancer), and for head and neck cancer, P276 will be administered in addition to the radiation.
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. Multiple phase II, and Phase I / II trials are ongoing in USA, and India.
Dr. Swati Piramal, Director, Piramal Group, said, "Piramal Life Sciences aims to reduce the burden of disease by finding new and affordable cures for unmet medical needs. Committed to the Group's values - knowledge, action and care, it focuses upon nurturing innovation and breakthrough thinking to impact the lives of millions, in dynamic, nimblefooted delivery and in making quality drugs accessible. We are happy and proud that our world-class dossier for P276 combination studies has been accepted by the Indian regulatory authorities."
Dr. Somesh Sharma, Managing Director, Piramal Life Sciences, stated, "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.
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