Piramal Healthcare today said it has completed the first phase of clinical trials of a new oral drug for treating cancer and will move to the next stage of development.
The company said it has established safety, apart from determining maximum tolerated dosages in humans for its new molecule code named P1446A-05 in multi-centric Phase-I trials conducted in India and Canada.
"We are extremely pleased with the results of the P1446A -05 and are committed to moving the molecule further in clinical development for the treatment of cancer," Piramal Healthcare Director Swati Piramal said in a statement.
The data of the Phase-I trials will be presented at the annual meeting of American Society for Clinical Oncology to be held in Chicago from June 1-5 this year, the company said.
The results of trials conducted in India and Canada, each investigating two different dosing schedules, will be reported in the meeting, it added.
"The completion of these two phase I studies readies P1446A-05...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 Executive Vice-President Clinical Research Alan Hatfield said.
Phase I clinical trials are conducted on a limited small number of human beings to establish safety, efficacy and check side effects on new drug molecules.
P1446A-05 exhibits high oral bio-availability, shows potent anti-proliferative activity in several human cancer cells and is efficacious in xenograft tumour models, Piramal Healthcare claimed.
The company further said: "P1446A-05 will be the second molecule in Piramal's oncology pipeline to enter Phase-II trials (conducted on a larger human sample)."
The first molecule P276 in in Phase II/III trials for multiple indications of cancer, it added.
Piramal Healthcare scrips were trading at Rs 420 per share in the afternoon trade on BSE, down 0.05% from the previous close.
