Piramal Healthcare Ltd. announced that Phase-I clinical trial data for its investigational new drug candidate P1446A-05 would be presented at the Annual Meeting of the American Society for Clinical Oncology or ASCO being convened in Chicago from June 1-5, 2012.
The company said this year's ASCO meeting would bring together more than 34,000 participants from around the world and focus on the theme of collaborating to Conquer Cancer.
The two posters (ASCO Abstract ID Nos. 3011 and 3013) from Piramal Healthcare and participating investigators to be discussed on Saturday after, June 2, 2012, in the Developmental Therapeutics - Experimental Therapeutics session, will report results of Phase-I clinical studies for P1446A-05 conducted in India and Canada, each investigating two different dosing schedules.
P1446A-05 is a potent inhibitor of cyclin dependent kinases (CDKs) which are enzymes that regulate the cell cycle. Dysregulation of the cell cycle is often observed in human malignancies which drives malignant growth and unbalances the normal balance between cell division and death. P1446A-05 exhibits high oral bio-availability, shows potent antiproliferative activity in several human cancer cell lines, and is efficacious in xenograft tumor models.
P1446A-05 will be the second molecule in Piramal's oncology pipeline to enter Phase-II trials. The first molecule P276 is in Phase II/III trials for multiple indications of cancer, the company said.
Results of Phase I clinical trials of P1446-05A
The company said the multi-centric trial in India was designed to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), safety profile, pharmacokinetics, and anti-tumor activity of P1446A-05, administered orally on an intermittent schedule (two weeks on treatment and one week off treatment) in patients with advanced refractory tumors until disease progression or unacceptable toxicity.
Twenty-nine patients with advanced cancer were dosed once per day on five separate dose levels. The drug was generally well tolerated and the MTD on this schedule was 600 mg per day. The trial was conducted at five centers across India.
In the Canadian trial, feasibility, safety and tolerability, pharmacokinetics, and anti-tumor activity of P1446A-05 administered in a continuous daily dosing schedule in patients with advanced malignancies was studies. Thirty-nine patients were dosed continuously once per day at five separate dose levels. Again the drug was generally well tolerated and the MTD on this schedule was 350 mg per day. The trial was conducted at three centers in Canada.
Executive Vice President-Clinical Research Alan Hatfield said, "The completion of these two Phase-I studies readies P1446A-05, an oral CDK inhibitor administered daily, to enter into a broader context of clinical development across a spectrum of malignant diseases. It offers continuous exposure to the targets and has a profile that can be integrated with other therapies."
Piramal Healthcare Director Swati Piramal commented, "We are extremely pleased with the results of the Phase I study of P1446A-05 and are committed to moving the molecule further in clinical development for the treatment of cancer."
At the BSE, Piramal Healthcare shares are currently trading at Rs.421.00, up Re.0.19 percent from the previous close.
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