ODC Therapy, Inc. Reports Melanoma Vaccine Research Results

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ODC Therapy, Inc., a cancer immunotherapy company started by Baylor Health Care System, announced today that data from an ongoing Phase 2 trial of its dendritic cell vaccine for the treatment of metastatic melanoma were presented Sunday, June 4 at the 2006 American Society of Clinical Oncology (ASCO) Annual Meeting in Atlanta.

Anna Karolina Palucka, M.D., Ph.D., Michael A.E. Ramsay Chair for Cancer Immunology Research, Baylor Institute for Immunology Research, reported on the multi-center trial in patients with stage IV metastatic melanoma. The trial follows a two-stage design in which at least one objective response (RECIST criteria) must be seen among the first 19 patients in the study in order for the study to continue accruing to its maximum enrollment.

“We observed one partial response among the first six patients we evaluated for response,” says Dr. Palucka. “Thus, we will continue to accrue to the planned enrollment of 32 patients.”

Unlike other autologous dendritic cell vaccines, ODC’s vaccine is generated using killed allogeneic tumor cell lines, resulting in a multivalent vaccine that has been shown in vitro to cross-prime nai"ve, tumor-specific CD8+ T cells. This trial represents the first clinical use of a frozen formulation of the Company’s vaccine. Freezing the vaccine makes it possible to produce a full series of vaccinations from a single blood collection, increasing convenience for the patient and physician.

ODC’s melanoma vaccine is also being evaluated in a second multi-center Phase 2 trial in combination with a non-cytotoxic dose of cyclophosphamide. At low doses, cyclophosphamide selectively depletes regulatory T cells that are believed to interfere with the development of an immune response to the vaccine.

Established in 2004, ODC Therapy Inc. is a privately held company focused on the development and commercialization of active (vaccine) and passive (monoclonal antibody) immunotherapies for cancer. ODC has licensed a portfolio of intellectual property from Baylor Research Institute and Rockefeller University and has the option to license additional developments in cancer immunotherapy from Baylor Research Institute.

Presently, ODC is seeking to raise capital through a Series A preferred offering. The Company’s cancer vaccines are produced by removing dendritic cell precursors from a patient’s bloodstream, culturing and loading the cells with tumor antigens and then reintroducing them back into the same patient. In addition to its melanoma vaccine, ODC has a vaccine candidate for prostate cancer that is expected to enter the clinic later this year. A monoclonal antibody to a novel pharmacologic target in breast cancer is in preclinical development.

Baylor Health Care System

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