Pharmaceutical Business review

Peregrine receives Indian regulatory approval for cancer trial

Peregrine is following the lead of many pharmaceutical companies including Pfizer, GlaxoSmithKline, Roche and Eli Lilly that have recently been conducting major clinical trials in India, taking advantage of the country’s clinical research facilities.

The trial is designed to test the safety and efficacy of Cotara in patients with glioblastoma multiforme, a deadly form of brain cancer. Previous studies using Cotara to treat brain cancer have produced encouraging results.

The new safety and efficacy study is expected to be an integral part of Peregrine’s overall Cotara brain cancer development program. It will enroll up to 40 patients with glioblastoma who have experienced their first relapse. The primary endpoints of the trial are to confirm safety, determine survival time and time to disease progression. Patient enrollment in the study is expected to be completed by the end of 2007.

“We have previously generated encouraging results using Cotara in this lethal cancer, and this study should allow us to evaluate the potential of the drug to extend patient survival more rapidly than we had originally anticipated,” said Steven King CEO, Peregrine.