Navigation Links
Advantagene Announces SPA Agreement With FDA to Launch Phase 3 Trial for Novel Vaccine Aimed at Preventing Prostate Cancer Recurrence

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 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.

Contacts for further information:

For more information about ProstAtak™ and Advantagene, please visit the Company's website at

Company Inquiries:

Brian Guzik

Partnering Inquiries:

Jefferson Davis
Extera Partners
617-225-7700 x245

This press release was issued through eReleases(R).  For more information, visit eReleases Press Release Distribution at

SOURCE Advantagene, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Vermillion Announces the Appointment of Bruce Huebner to its Board of Directors
2. Ontario Institute for Cancer Research Announces Spin Off Companies Developing Promising Anticancer Technologies
3. ShangPharma Announces First Quarter 2011 Results
4. BioSpecifics Technologies Corp. Announces Data Presentations at Upcoming XVI Annual Federation of the European Societies for Surgery of the Hand Meeting
5. Watson Pharmaceuticals Announces New Research Showing RAPAFLO(R) (silodosin) Improves Outcomes for Chronic Prostatitis/Chronic Pelvic Pain Syndrome
6. Pfenex Inc., Through Its Reagent Proteins Business Division, Announces Submission of Biologics Master File for Recombinant CRM197 to US FDA
7. ACT Announces Oregon Health & Science University as Clinical Trial Site for its Phase 1/2 Clinical Trial Using hESC-Derived RPE Cells for Macular Degeneration
8. InterMune Announces Presentation of Positive Pirfenidone Data at the International Conference of the American Thoracic Society (ATS)
9. Spherix Announces First Quarter Financial Results
10. Stem Cell Assurance Announces the Filing of Its Form 10 Registration Statement
11. 3SBio Inc. Announces Unaudited First Quarter 2011 Results
Post Your Comments:
(Date:11/24/2015)... Schlieren, Switzerland (PRWEB) , ... November 24, 2015 , ... ... more organotypic 3D cell culture models, has promoted Melanie Aregger to serve as Chief ... Manager, Ms. Aregger served on the management team and was promoted to ...
(Date:11/24/2015)... , Nov. 24, 2015 /CNW Telbec/ - ProMetic Life Sciences ... today that Mr. Pierre Laurin , President and Chief ... at the upcoming Piper Jaffray 27 th Annual Healthcare ... on December 1-2, 2015. st , at ... one-on-one meetings throughout the day. The presentation will be available ...
(Date:11/24/2015)... , Nov. 24, 2015 HemoShear ... on discovering drugs for metabolic disorders, announced today ... to its Board of Directors (BOD). Mr. Watkins ... of Human Genome Sciences (HGS), and also served ... Jim Powers , Chairman and CEO ...
(Date:11/24/2015)... YORK , November 24, 2015 ... in a European healthcare ... which the companies will work closely together in identifying European ... unmet medical need. The collaboration is underpinned by a significant ... fund. This is the first investment by Bristol-Myers Squibb in ...
Breaking Biology Technology:
(Date:11/19/2015)... Nov. 19, 2015  Based on its in-depth analysis ... recognizes BIO-key with the 2015 Global Frost & Sullivan ... & Sullivan presents this award to the company that ... the needs of the market it serves. The award ... and expands on customer base demands, the overall impact ...
(Date:11/18/2015)... ALBANY, New York , November 18, 2015 /PRNewswire/ ... Transparency Market Research has published a new market report ... Share, Growth, Trends, and Forecast, 2015 - 2021. According to ... bn in 2014 and is anticipated to reach US$29.1 ... 2015 to 2021. North America ...
(Date:11/17/2015)... LIVERMORE, Calif. , Nov. 17, 2015  Vigilant ... has joined its Board of Directors. ... Vigilant,s Board after recently retiring from the partnership at ... owning 107 companies with over $140 Billion in revenue.  ... performance improvement across all the TPG companies, from 1997 ...
Breaking Biology News(10 mins):