Mumbai, January 15, 2009: Piramal Life Sciences Limited (PLSL) announced today that it has started phase II trial in USA for its lead cancer compound P 276-00 to treat Mantle cell Lymphoma (MCL) and it is the second IND approved by the US FDA for this compound.
MCL is a subtype of non-Hodgkin lymphoma that has 59,000 new cases in the United States each year. Despite the availability of novel agents, MCL remains an incurable disease for most patients, with a median survival of 3 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. Therefore, there is still a need for a targeted, safe and effective therapy.
In most of the MCL cases, genetic and epigenetic events result in over expression of cyclin D1 which provide tumor cells a selective growth advantage. Inhibition of cyclins/Cdks, therefore, offers an attractive mechanism for treatment of this cancer. P276 is a new chemical entity that inhibits Cdk4/cyclinD1 and has been found to be well tolerated and safe in two phase I clinical studies carried out in Canada and India. A number of sites in USA will participate in this phase II clinical trial including University of Wisconsin, Madison, where the clinical study will be coordinated by Dr Brad Kahl -a world-renowned authority in Mantle cell Lymphoma.
Dr. (Mrs.) Swati Piramal, Vice Chairperson, Piramal Life Sciences Limited said, “Piramal Life Sciences aims to reduce the burden of disease by finding new and affordable cures for unmet medical needs. It is a proud moment for Indian research and an important milestone because a drug discovered in India, with global patents is now being tested at world- renowned cancer hospitals in the USA."
Dr Somesh Sharma, Managing Director, Piramal Life Sciences Ltd., stated, " Piramal Life Sciences is committed to the Group's values - knowledge, action and care. We nurture breakthrough thinking and follow it up with dynamic, nimble-footed delivery to impact lives of millions of people. The initiation of phase II clinical trials of P276 in mantle cell lymphoma patients in the US further highlights PLSL’s capabilities in developing a compound to address unmet medical needs worldwide."
Notes to Editors:
About the Piramal Group
Spanning a broad spectrum of industries and formats, the Piramal Group is committed to achieving excellence and leadership by adhering to ethically sound, innovative and value-driven practices in its diverse, yet focused, business ventures and initiatives. The Group’s turnover exceeded US $ 900 million in FY 2008.
About Piramal Life Sciences Limited
Piramal Life Sciences Limited (“PLSL”) is an independent research driven drug Company that was demerged from Nicholas Piramal India Limited (NPIL, name since changed to Piramal Healthcare Limited). PLSL was formerly the NCE R&D division of PHL. PLSL has state-of-the-art R&D laboratories built over 200,000 square-feet of space in Mumbai, India and over 300 scientists engaged in drug discovery and development. PLSL is focused on four therapeutic areas – Cancer, Diabetes, Inflammation and Infectious Diseases. The Company has a pipeline of fourteen compounds, including five in clinical trials. PLSL’s lead chemical compound, a Cdk-4 inhibitor, has completed two phase 1 studies and is being tested in another Phase I/II trials for Multiple Myeloma. PLSL has drug discovery and developments agreements with Eli Lilly & Company and Merck & Company, two of the leading pharmaceuticals companies in the world.
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