Cancer Researcher Dr. Steven O'Day Announces Positive Results in Multicenter Trial of New Agent against Deadly Melanoma.

LOS ANGELES -- A new molecule designed to battle advanced metastatic melanoma doubles the Progression-Free Survival rate of cancer patients compared with those receiving a conventional treatment, according to Steven O'Day, M.D., chief of research and director of the Melanoma Program at The Angeles Clinic and Research Institute in Los Angeles. Dr. O'Day, who served as principal investigator of a multicenter study to evaluate the new molecule, presented the full study results Saturday, September 16, at a joint melanoma conference taking place near Amsterdam.

The double-blind, randomized Phase 2b clinical trial of the novel anticancer agent STA-4783 involved 81 Stage IV melanoma patients at 21 medical centers across the U.S. Stage IV means the cancer has spread from the primary site to other tissues. With melanoma, Stage IV cases are highly resistant to therapy; median survival time is only six to nine months, underscoring the need for better treatments.

STA-4783 was developed by Synta Pharmaceuticals Corp., a Massachusetts biotechnology company which also funded the study. The drug induces tumor cells to produce a heat shock protein on the cell surface, which flags them for destruction by the patient's own immune system.

Patients received a combination of STA-4783 plus paclitaxel (a standard chemotherapy drug), or paclitaxel alone for several weeks. Results show that patients receiving STA-4783 plus paclitaxel had a median Progression-Free Survival (PFS) rate of 112 days, compared with 56 days for those receiving paclitaxel alone. The difference -- a doubling of the PFS -- was statistically significant, and met the trial's prospective primary endpoint.

Currently, only two FDA-approved drugs are available for patients with Stage IV melanoma, and both have limited efficacy, with response rates of 7 percent to 10 percent. "We have much more effective drugs for other cancers, like breast and colon cancer," said Dr. O'Day. "The prospects for patients with advanced melanoma have been historically poor, which is why these results are so encouraging. Positive data for STA-4783 in a clinical trial as rigorous as this offers hope to patients and doctors alike."

"We now have a 'proof of concept' that has never been seen with any therapeutic intervention in advanced melanoma," O'Day explained. While researchers have yet to determine whether STA-4783 will improve overall patient survival, "We have proven that STA-4783 can make paclitaxel more active and slow the progression of disease. There may be more combinations or sequences of therapies that can be developed in the future with even greater impact."

"The field of cancer medicine has changed enormously in the past five years, and continues to evolve rapidly. In order to offer our patients the best available treatments, we have to work at the leading edge of medical research," Dr. O'Day said. "The results with STA-4783 inspire us to continue our Phase 2 studies of new drugs to fight melanoma," he added. "You never know which molecule is going to be successful, so it's vital that we try to get every promising agent into a clinical trial."

Dr. O'Day was chosen by Synta Pharmaceuticals to serve as the project's principal investigator due to his extensive experience in melanoma research, including the application of new anticancer agents. For the STA-4783 trial, he assisted with the study design and recruitment process, monitored the safety data, and supervised the 21 participating research centers.

The Angeles Clinic, a leading center for cutting-edge medical treatments, treated a significant number of patients on the STA-4783 trial. "The Angeles Clinic was established as a center where cancer patients could get the best, most advanced care, including access to clinical trials of novel treatments such as STA-4783," explained The Angeles Clinic Chief Executive Officer Lawrence D. Piro, M.D. "Dr. O'Day has built an outstanding team at the Clinic, and his role in leading this trial is an example of the robustness of our melanoma research program. Patients come from all over the country to the Clinic for access to clinical trials such as this, and it's exciting that we are helping to make progress in establishing the efficacy of new molecules to treat melanoma."

Dr. O'Day believes that the Clinic is well-positioned to support breakthroughs in cancer medicine because it attracts highly specialized doctor-researchers, as well as patients who are seeking the most advanced treatments. "This combination of disease experts, an excellent clinical research infrastructure, motivated research participants, and our ability to provide reliable data that can advance a drug to market creates a win-win situation for doctors, patients and companies such as Synta who are developing novel agents to fight cancer."

About The Angeles Clinic and Research Institute

The Angeles Clinic and Research Institute was founded in 1999 as a center of excellence for both clinical practice and cancer research. It specializes in treating all forms or cancer and provides patients access to advanced treatments, especially for breast cancer, melanoma and lymphoma, as well as prostate and colon cancer. Full results of the STA-4783 trial will be presented by Dr. O'Day at the joint Perspectives in Melanoma X and the Third International Melanoma Research Congress, Noordwijk, The Netherlands on September 16, 2006. For details, visit www.imedex.com/announcements/251.asp.

For more information, contact Sandy Binder at The Angeles Clinic and Research Institute, 2001 Santa Monica Boulevard, Suite 560W, Santa Monica, CA 90404, 310-582-7936, www.theangelesclinic.org.