DCGI gives approval to Piramal Life Sciences for conducting trails
The Drug Controller General of India (DCGI) gave approval to Piramal Life Sciences Limited for conducting phase-I/II combination studies of its cancer molecule P276 for pancreatic, head and neck cancer.
Piramal Group director Swati Piramal said, "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.''
The company said that more than 2,00,000 cases of neck and head cancer are diagnosed in India and worldwide respectively.
It added: ''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.''
Company officials stated that 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.