Piramal Healthcare announced that phase I clinical trial data for its investigational new drug candidate P1446A-05 will be presented at the annual meeting of the American Society for Clinical Oncology (ASCO), which will be held in Chicago from June 1-5, 2012. More than 34,000 participants from around the world will participate and focus on the theme ‘Collaborating to Conquer Cancer.’
The two posters (ASCO Abstract ID numbers 3011 and 3013) from Piramal Healthcare and participating investigators to be discussed on 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.
Dr Alan Hatfield, Executive Vice President, Clinical Research, Piramal Healthcare commented, “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.”
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 bioavailability, shows potent anti-proliferative activity in several human cancer cell lines, and is efficacious in xenograft tumour 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 multi-centric trial in India was designed to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), safety profile, pharmacokinetics, and anti-tumour activity of P1446A-05, administered orally on an intermittent schedule (two weeks on treatment and one week off treatment) in patients with advanced refractory tumours until disease progression or unacceptable toxicity.
29 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 centres across India that included Tata Memorial Centre, Mumbai; Ruby Hall Clinic, Pune; SEAROC Cancer Centre, Jaipur; Jehangir Clinical Development Centre, Pune; Bhagwan Mahaveer Cancer Hospital and Research Centre, Jaipur; and Central India Cancer Research Institute, Nagpur.
In the Canadian trial, feasibility, safety and tolerability, pharmacokinetics, and anti-tumour activity of P1446A-05 administered in a continuous daily dosing schedule in patients with advanced malignancies was studied. A total of 39 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 centres in Canada: Tom Baker Cancer Centre, Calgary, AB; Cross Cancer Institute, Edmonton, AB; and London Regional Cancer Program, London, ON.
Dr Swati Piramal, Director, Piramal Healthcare, commenting on the presentations at the ASCO Annual Meeting, stated, “We are 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.”
Dr Somesh Sharma, Chief Executive Officer, Drug Discovery and Development, Piramal Healthcare, stated, “Our goal is to develop cancer medicines that improve care in a way that is meaningful to patients. The successful completion of the phase I clinical trial of our orally acting anticancer compound P1446A-05 is an important step towards this goal.”
These presentations at the 2012 ASCO annual meeting on the oral anticancer compound P1446A-05 highlight Piramal Healthcare’s continued commitment to exploring new treatment options for cancer through novel mechanisms and targets, and building up a robust oncology pipeline.
EP News Bureau — Mumbai