Contact: Wendy Walker, (214) 820-4581
Email: wendyw@BaylorHealth.edu

DALLAS, June 23, 2005) - ODC Therapy Inc., a privately held affiliate of Baylor Health Care System, announced today the acceptance by the Food and Drug Administration (FDA) of an investigator-initiated clinical trial of its lead product, a patient-specific cancer vaccine for late-stage metastatic melanoma patients developed by Baylor Research Institute. Metastatic melanoma is the deadliest form of skin cancer.

"We are encouraged by the favorable and timely review of this Investigational New Drug Application and attribute our success to a dedicated team led by our Scientific Co-Investigators Karolina Palucka, M.D., Ph.D., and Jacques Banchereau, Ph.D., at the Baylor Institute for Immunology Research," said Michael Ramsay, M.D., president of Baylor Research Institute. "We look forward to expanding access to this novel therapy through rigorous clinical and manufacturing development." Baylor Institute for Immunology Research is a component of Baylor Research Institute.

John Nemunaitis, M.D., medical director of the Mary Crowley Medical Research Center, which is located on the Baylor University Medical Center campus, will serve as the principal investigator of the research trial.

In a recent Phase I dose escalation trial, 20 patients with metastatic melanoma were treated with the first generation vaccine. While the results of this trial are still being analyzed, one patient has demonstrated a complete remission and another partial remission. At 29 months since the beginning of the trial, 10 of the patients are still alive.

To support the manufacturing of the vaccine, Baylor Health Care System recently completed construction and equipped a $2.4 million, 2,200-square-foot customized cell-processing facility. The new facility is designed for compliance with the FDA's current Good Manufacturing Practices and is located at the Baylor Institute for Immunology Research on the Baylor University Medical Center campus. The technologically advanced facility will enable the manufacture, controlled freezing and storage of patient-specific vaccines and includes three 400-square-feet, Class 10,000 processing suites and an automated filling machine.

In July 2004, ODC Therapy Inc. received a $4 million seed financing investment from the Baylor Health Care System to develop, produce and distribute customized cancer vaccines to individual patients and monitor their immune response after treatment. ODC has licensed a portfolio of intellectual property from Baylor Research Institute and Rockefeller University in the fields of immunotherapy and immunomonitoring.

Baylor Research Institute and Baylor University Medical Center at Dallas are affiliates of Baylor Health Care System.

For more information about the melanoma clinical trial at ODC Therapy Inc., call 1-800-4BAYLOR.

Melanoma
According to the American Cancer Society (ACS), Cancer of the skin is the most common of all cancers. Melanoma accounts for about 4 percent of skin cancer cases, but it causes about 79 percent of skin cancer deaths. The number of new cases of melanoma in the United States is on the rise. ACS estimates that in 2005 there will be 59,580 new cases of melanoma in this country. About 7,770 people will die of this disease.