AUBURNDALE, Mass., May 19, 2011 /PRNewswire/ -- 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 e
|SOURCE Advantagene, Inc.|
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