Advantagene reaches SPA agreement with FDA for ProstAtak Phase 3 trial to prevent prostate cancer recurrence

Advantagene, Inc., a Massachusetts-based biopharmaceutical company, announced today that it reached an agreement with the U.S. Food and Drug Administration on a Special Protocol Assessment (SPA) for a pivotal Phase 3 clinical trial of ProstAtak™, its lead agent for patients with newly diagnosed prostate cancer. The trial is expected to accrue 711 patients starting mid-2011 with definitive results expected by 2015. The randomized study will evaluate ProstAtak's ability to prevent prostate cancer recurrence. If successful, it could yield the first drug product for newly diagnosed, localized prostate cancer.

Prostate cancer is the second most common cause of death in American men. The American Cancer Society estimates there were approximately 220,000 new prostate cancer diagnoses in 2010. And, although most patients will live at least 5 years after diagnosis, each year over 60,000 men develop recurrence of the cancer and 32,000 die of their disease.

"The SPA and initiation of this pivotal study are aimed at addressing a critical unmet medical need," said Dr. Estuardo Aguilar-Cordova, Founder and CEO of Advantagene. "If successful, ProstAtak would be the first-ever product to vaccinate against the recurrence of a cancer, in this case prostate cancer."

Since no curative therapy currently exists for recurrent prostate cancer, only palliative treatments that compromise quality of life, such as surgical or medical castration, are employed. Once these approaches fail, options include the recently approved immunotherapy Provenge® (Dendreon) or the chemotherapies Zytiga® (Johnson & Johnson) and Jevtana® (Sanofi), which provide modest survival improvements. Advantagene researchers have taken another approach entirely, i.e. preventing prostate cancer death by preventing recurrence. ProstAtak™ is designed as an "off-the-shelf" drug to kill tumor cells and stimulate a vaccine effect against the patient's specific tumor, in essence activating the patient's own immune system to prevent tumor recurrence.

Historically, development of therapies for newly diagnosed prostate cancer has been hindered by the very slow progression of this disease. "Based on our previous data, we were able to design a novel clinical approach that allows efficacy assessment at 24-36 months," stated Dr. Aguilar-Cordova.

Protocol development was co-chaired by Drs. Theodore DeWeese, Chair of Radiation Oncology at Johns Hopkins, and Peter Scardino, Chief of Surgery and Chair of Urology at Memorial Sloan Kettering Cancer Center. "We are delighted to lead this study. I participated in early trials with this product, and am enthusiastic that this randomized trial will definitively evaluate its potential," stated Dr. Scardino. If successful, this could be a major advance for patients and the development of new therapies for prostate cancer.