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Piramal Life Sciences receives DCGI Approval to conduct two Phase I / II Combination Trials of P276 for Pancreatic and Head & Neck Cancer in India

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Piramal Life Sciences Limited, part of the Piramal Group of companies, has received regulatory approval by Drug Controller General of India (DCGI) for the initiation of two phase-I/II combination studies of its cancer molecule P276 for pancreatic and head & neck cancer. The objectives of both studies are to identify right doses of P276 to be used in combination with chemotherapeutic drugs and to evaluate the therapeutic benefit of the combination of drugs in pancreatic, and head and neck cancer patients.

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.”

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 & 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.

Written by sreelakshmi

22 May, 2009 at 6:57 am

Piramal Life Sciences initiates Phase II trials of P276 for Mantle Cell Lymphoma

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Piramal Life Sciences Limited (PLSL) announced that it has started phase II trial in USA for its lead cancer compound P 2 76-00 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 tumour 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, PLSL 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, 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.”

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Written by sreelakshmi

17 January, 2009 at 12:21 pm