Prostate Cancer Advocates Unite to Fight for Immediate FDA Approval of First-of-Its-Kind Cancer Vaccine--- Unprecedented "ProvengeNow" Coalition to assemble on Capitol Hill --

Business Wire


NEW YORK, May 23, 2007 (BUSINESS WIRE) -- Patients, survivors, physicians and caregivers have formed a coalition called ProvengeNow to fight the recent decision by the U.S. Food and Drug Administration to delay the approval of a new and safe immunotherapy vaccine treatment, until more data becomes available in 2010.

Advocates that are a part of this initiative thus far include: Us TOO! International, The Prostate Health Education Network (PHEN), Prostate Cancer Research Institute, Malecare, Survivors Celebration, Raise a Voice, Patient Advocate for Advanced Cancer Treatments (PAACT) along with prostate cancer expert Mark A. Moyad, M.D., M.P.H.

With chemotherapy as the only available treatment for men with advanced, hormone-refractory prostate cancer, members of ProvengeNow hope to extend the lives of these patients and also give them a better quality of life with this new landmark treatment, Provenge. In fact, a survey conducted by Us TOO! showed that more than half of men with prostate cancer do not want to take chemotherapy.

"We believe that the FDA's decision to delay approving a safe, effective treatment for prostate cancer patients is inhumane," said Thomas Farrington, charter member of ProvengeNow and founder and president of PHEN. "Furthermore, we are saddened and concerned the FDA has blatantly ignored - not only its own advisory panel of experts - but the voices of the patients. We urge them to approve Provenge immediately to give patients this treatment option."

Provenge is the first immunotherapy vaccine to complete phase III clinical trials and to demonstrate both safety and substantial efficacy for prostate cancer. An FDA advisory panel recommended the approval of Provenge; the panel voted 17 - 0 that the treatment was safe and 13 - 4 that it demonstrated substantial efficacy.

"We are disappointed and disagree with the FDA's decision not to approve Provenge based on the overwhelming support from their expert advisory committee, and we believe this decision should be immediately revisited and evaluated," said Dr. Mark Moyad of the University of Michigan Medical Center. Dr. Moyad, who is the Director and leader of a group of medical supporters goes on to state that, "With only one drug approved that many of these men either don't want or cannot tolerate, why is it so difficult to understand that men with advanced prostate cancer need and deserve more and better treatment options to choose from?!"

ProvengeNow is urging prostate cancer patients, survivors, health care professionals, caregivers and anyone else who is interested in fighting cancer to join the campaign by:

-- Joining ProvengeNow on Capitol Hill to petition members of Congress on June 4th and 5th in Washington, D.C.

-- Emailing a message of support to [email protected], which will be sent to the FDA

-- Contacting the FDA directly

-- Asking our members of Congress to take action

-- Please visit the website at for more ways to take action!

About ProvengeNow:

ProvengeNow is a patient advocate initiative created to gain immediate FDA approval for the first-ever Active Cellular Immunotherapy treatment for Prostate Cancer. Survivors hope to extend their lives with a better quality with this new type of landmark treatment.

Provenge is a symbol for a new era in prostate cancer treatment.Patient advocates do not dispute the FDA's request for more clinical data. The ProvengeNow position is that this confirmatory data should be submitted post approval and that Provenge should be approved now by the FDA for patient use.

The ProvengeNow advocate organizations support immediate approval of new prostate cancer treatments to expand the options available to patients, including Active Cellular Immunotherapy.

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