Piramal Life Sciences Limited, part of the Piramal Group of companies, has received regulatory approval for the initiation of a phase-I study in India by Drug Controller General of India (DCGI) of a new cancer compound, P-1446A-05.
P-1446A-05 is an orally active molecule being developed for the treatment of cancer for which there is inadequate treatment options. P-1446A-05 is an inhibitor of key enzymes involved in the uncontrolled division and multiplication of cancer cells.
Recently, PLSL has also received a regulatory approval for the initiation of a phase-I trial for this compound in Canada. The primary objective of both studies is to identify a safe and tolerable dose to be administered in subsequent phase-II trials.
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, nimble-footed delivery and in making quality drugs accessible. We are happy and proud that our world-class dossier for P-1446A-05 has been accepted by the Indian regulatory authorities. Our earlier cancer compound P276 is currently in phase-II trials."
Dr Somesh Sharma, managing director, Piramal Life Sciences, stated, "This is our seventh entity to enter the clinic and third in oncology and bears testimony to our efforts to build a diversified and strong pipeline of products to address unmet medical needs in this important therapeutic segment."