Piramal Life Sciences (PLSL) has started phase-II trial in USA for it's 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 three to five 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.
Dr 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."
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 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."