Thursday, May 19, 2011

FDA agreement aids Advantagene prostate treatment trial

By James M. Connolly

Biopharmaceutical company Advantagene Inc. said today that it has reached an agreement with the U.S. Food and Drug Administration on a Special Protocol Assessment for a Phase 3 clinical trial of ProstAtak, its lead agent for men with newly diagnosed prostate cancer.

Based in Newton, Advantagene said it expects to have 711 patients in the trial beginning this year, and it expects to have definitive results by 2015. The trial will focus on ProstAtak’s ability to prevent a recurrence of prostate cancer.

Advantagene is designed to prevent prostate cancer recurrence and deaths by killing tumor cells and stimulating a vaccine effect against the patient’s specific tumor, “in essence activating the patient’s own immune system to prevent tumor recurrence,” said the company in a press release.

Advantagene noted that prostate cancer is the second most common cause of death in American men, citing American Cancer Society estimates of 220,000 new prostate cancer diagnoses in 2010, and an average of 32,000 deaths each year.

The Special Protocol Assessment agreement and the study are aimed at a “cricical unmet medical need,” according to the company. CEO Estuardo Aguilar-Cordova said that if it is successful, ProstAtak could be the first product to vaccinate against recurrence of a cancer.

In another initiative on cancer, Cambridge-based Foundation Medicine Inc. this week said it is collaborating with Celgene Corp. on cancer research, with Celgene utilizing Foundation Medicine’s cancer genomics tests in clinical drug trials focused on various cancers, including prostate cancer.