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First FDA Approval of Therapeutic Cancer Vaccine a Milestone Victory for Cancer Immunotherapy

Provenge, a therapeutic vaccine for prostate cancer, is the first immunotherapy to be approved by the U.S. Food and Drug Administration

NEW YORK, NY – April 30, 2010 – The Cancer Research Institute celebrates yesterday’s announcement of the first therapeutic cancer vaccine to receive approval from the U.S. Food and Drug Administration. The vaccine, called Provenge, is produced by Seattle biotech company Dendreon (NASDAQ:DNDN) and is designed to treat certain forms of advanced prostate cancer.

“The approval of a vaccine to treat cancer is a victory in the history of cancer therapy, and signals the beginning of a new era in cancer medicine,” said Jill O’Donnell-Tormey, Ph.D., executive director of the U.S.-based Cancer Research Institute (CRI), a nonprofit organization founded in 1953 that has provided decades of significant support to cancer immunology researchers around the world so that the development of cancer immunotherapies such as Dendreon’s Provenge might one day be possible.

“Our organization was the first to explore the immune system and its relationship to cancer,” O’Donnell-Tormey said. CRI founder Helen Coley Nauts established the Institute in 1953 after she became convinced of the promising medical discoveries of her father, a surgeon practicing medicine in New York from the late 1800s to early 1900s named William B. Coley, M.D., who had found a way to stimulate anti-tumor immune responses in inoperable cancer patients. “Since then, we have invested all our resources—more than $200 million dollars—in providing scientists with the means to unlock the power of our immune system to fight cancer.”

Similar to many other promising cancer immunotherapies currently under development around the globe, Provenge attempts to harness the body’s natural ability to fight cancer by mobilizing the immune system to find and eliminate cancer cells. Because most of these treatments target specific molecular markers that can distinguish cancer cells, they have the potential to eliminate tumors without causing many of the negative side effects associated with chemotherapy, radiation therapy, and surgery.

The final approval of Dendreon’s vaccine was based on a large, phase III clinical trial where Provenge showed a statistically significant improvement in overall survival of men with metastatic hormone-resistant prostate cancer. Dendreon’s study of 512 men demonstrated that when compared to a placebo, Provenge increased three-year survival by 38 percent and extended median overall survival by 4.1 months.

As a first generation therapeutic cancer vaccine, Provenge demonstrates important proof-of-principle for this emerging class of active cancer immunotherapies. However, most experts in the field would agree that scientists are just beginning to scratch the surface of these vaccines’ full therapeutic potential.

CRI Scientific Advisory Council director Lloyd J. Old, M.D., a pioneer responsible for many seminal discoveries in the field, is a senior expert in tumor immunology who for the past four decades has guided the scientific vision for CRI and who currently leads the Institute’s global cancer vaccine research programs.

“The FDA approval of Provenge is a landmark for the field of cancer immunology and immunotherapy, adding strength to the concept of immunological control of cancer and demonstrating the commercial viability of the approach,” Old stated. “The challenge now is to maximize the effectiveness of cancer vaccines such as Provenge by incorporating all we have learned in recent years about the immune response to cancer and cancer vaccine development, converting the four-month survival advantage of Provenge-vaccinated patients into prolonged—even lifelong—control of the disease.”

Old, who also heads the Ludwig Institute for Cancer Research (LICR) New York Branch and has served for many years as director of LICR’s worldwide scientific programs, says that, eventually, vaccines will treat a wide variety of cancer types, recruiting the immune system to stop the progression of patients’ tumors and helping to fully stabilizing the disease.

“Based on the clinical evidence we’ve gathered over the past decade in our cancer vaccine trials,” Old said, “and in light of data from a variety of trials by others within the field, we believe therapeutic cancer vaccines will increasingly emerge as one of the safest and most powerful ways to combat a variety of cancers.”

In an effort to accelerate the development, refinement, and approval of more cancer immunotherapies, the Cancer Research Institute has a developed a comprehensive strategy that draws upon several complementary resources and programs.

First, in 2001, CRI formed a partnership with the Ludwig Institute for Cancer Research to develop the Cancer Vaccine Collaborative (CVC)—a centralized, academic, global network of clinical trial sites, immune monitoring laboratories, and clinic-grade, GMP cancer vaccine production facilities. Since the program’s inception, CVC investigators have treated nearly 700 cancer patients in more than 40 early phase clinical trials of therapeutic cancer vaccines.

Most recently, CRI has launched a new “venture philanthropy” program called the Cancer Vaccine Acceleration Fund (CVAF) as a means to catalyze development of next-generation therapeutic cancer vaccines and other immunotherapies by helping to address the critical shortage of capital available for early stage clinical trials. CVAF identifies the most promising cancer vaccines in global development and then works to provide significant funding and access to the CVC clinical trials network to ensure that these important new medicines can move smoothly into and through early phase clinical trials.

Complementing these research efforts are those of the Cancer Immunotherapy Consortium (CIC), which is now a program of the Cancer Research Institute. With a membership that includes representatives from biotech and pharmaceutical companies as well as academia, the CIC provides a platform aimed at making cancer immunotherapies part of the standard-of-care in oncology by finding solutions to scientific and developmental challenges.

Through the CIC program, the Cancer Research Institute conducts a number of important initiatives that seek among other things to build consensus across the field on key issues, to develop and implement new standards for carrying out and reporting immunological monitoring assays of therapeutic cancer vaccines, and to establish and promote the adoption of new criteria for evaluating the clinical impact of cancer immunotherapies.

“Through these interdependent programs as well as a variety of other initiatives designed to engender partnerships and foster cross-sector collaboration within the field, Cancer Research Institute will continue to be an engine of innovation and a source of leadership to the field,” O’Donnell-Tormey said.

“With the celebrated landmark approval of the first therapeutic cancer vaccine now here after decades of anticipation,” Old commented, “CRI and the field look forward to the oncoming wave of new immunotherapies that are making their way steadily toward the oncologist’s arsenal of weapons against cancer.”

“It’s a remarkable time for the field and for cancer patients,” O’Donnell-Tormey stated. “I can honestly say that in my 23 years at the Cancer Research Institute, I have never been more excited about the potential for cancer immunotherapy to revolutionize the way we think about cancer, the way we treat it, and the way we live with it. Provenge is just the beginning, and there is much more in store for the near future.”


Media Contact
Brian M. Brewer, Director of Communications, Cancer Research Institute
+1-212-688-7515, ext. 242, or bbrewer@cancerresearch.org

About the Cancer Research Institute
The Cancer Research Institute (CRI), established in 1953, is the world’s only nonprofit organization dedicated exclusively to transforming cancer patient care by advancing scientific efforts to develop new and effective immune system-based strategies to prevent, diagnose, treat, and eventually cure all cancers. Guided by a world-renowned Scientific Advisory Council that includes three Nobel laureates and 26 members of the National Academy of Sciences, CRI has invested $282 million in support of research conducted by immunologists and tumor immunologists at the world’s leading medical centers and universities, and has contributed to many of the key scientific advances that demonstrate the potential for immunotherapy to change the face of cancer treatment. To learn more, go to www.cancerresearch.org