USFDA approves Nicholas Piramal's IND-P276

Nicholas Piramal India Ltd (NPIL) has announced that the Company has received USFDA approval for its Investigational New Drug (IND) application of its lead cancer compound 'P-276-00' to treat 'Multiple Myeloma', a deadly form of blood cancer.

- Nicholas Piramal India Ltd's IND-P276- a new drug discovery from Mumbai, India has been approved by USFDA

- Clinical trials will start at Harvard University's Dana Farber Cancer Institute for Multiple Myeloma - a devastating type of cancer

"Nicholas Piramal India Ltd on July 23, 2007 has announced that the USFDA has approved its Investigational New Drug (IND) application of its lead cancer compound P 276-00 to treat Multiple Myeloma, a deadly form of blood cancer. It is the first IND from India for a NCE cancer drug approved by the USFDA.

Multiple Myeloma (MM) is the second most common hematologic malignancy, and is responsible for at least 2% of cancer-related deaths. MM remains an incurable disease for most patients, with a median survival of 4 to 5 years. High-dose chemotherapy followed by transplantation has resulted in improvement in response rates and survival compared with conventional therapy, but relapse is nearly universal and not all patients are candidates for this option of aggressive treatment.

It is estimated that there would be 16,570 new cases of MM diagnosed in the United States and 11,310 deaths attributed to this disease in 2006. More than 20,000 cases of MM are detected every year in India. Despite the availability of novel agents, MM remains incurable and most patients die from disease progression. P 276-00 is a new chemical entity that blocks pathways necessary for cancer cell growth and survival.

The Clinical Studies will be coordinated by Dr Kenneth Anderson -a world-renowned authority in Multiple Myeloma. The Principal Investigator of the trial will be Dr. Noopur Raje, M.D., at the Dana Farber - Massachusetts General Hospital. Dr. Noopur Raje is part of the Jerome Lipper Cancer center at the Dana-Farber Cancer Institute. Two additional sites - St. Vincent's Hospital, New York and Emory University Medical Center in Atlanta will also participate in this study. It is to be noted that recently India's former Prime Minister Mr. Chandrasekhar succumbed to this devastating type of cancer.

Dr. (Mrs.) Swati Piramal, Director - Strategic Alliances & Communications, NPIL said, "It is a proud moment for Indian research and an important milestone because a drug discovered in Mumbai India, with global patents is now approved for Clinical studies in world - renowned cancer hospitals in the USA. It is a testament to the world-class quality of the regulatory dossiers and preclinical studies which were completed entirely by the Indian scientific team. It also shows NPIL is delivering on the investments being made in research."

Source : Equity Bulls

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