Nicholas Piramal India has commenced the Phase-1 clinical trials of its cancer drug molecule, P276-00 at an oncology centre in Canada after obtaining the necessary permissions from the Canadian regulatory authorities.
It is the first time that a molecule has been put on human trials. Though the company had applied for permission in India as well, the regulatory approval for the clinical trials is still awaited.
NPIL sources said that it could take 9-12 months to enroll 30-35 patients to complete the Phase-1 and 2 studies that will help determine a safe and possible efficacious dose, which will be used in further clinical studies.
In addition to examining the improvements that may be observed on CT scans of the treated patients, an innovative clinical trial design is being employed, which will also help evaluate the drug's effect even at the cellular level.
This will assist in further refining the strategies for additional Phase-2 studies in treating cancer.
P276-00 is the first in a series of compounds from Nicholas Piramal Research Centre to enter into clinical trials.
