CYTOGEN ISSUES CANCER THERAPY PHASE I RESULTS UPDATE
CYTOGEN ISSUES CANCER THERAPY PHASE I RESULTS UPDATE PRINCETON, N.J., Nov. 18 /PRNewswire/ -- Cytogen Corporation
(NASDAQ: CYTO) today announced significant results in the Phase I human clinical studies of OncoRad 103, the company's ovarian cancer therapy agent.
OncoRad uses a monoclonal antibody linked with a radioisotopic therapy agent, Yttrium 90. This allows for the direct delivery of the cell killing radioisotope to the cancer sites, making it possible to deliver a higher dose of radiation while mitigating side effects. On Nov. 8, at a New York City symposium for the medical oncology community, Dr. John J. Kavanagh, of M.D. Anderson Hospital and Tumor Institute (Houston), presented results of an ongoing study designed to establish the safety and preliminary efficacy of escalating doses of OncoRad 103 for ovarian cancer therapy. He reported that of nine patients treated with a 10 to 15 millicurie (mCi) dose of Yttrium 90, and followed for intervals of 15 months or longer, there has been one complete tumor response, and two high-risk patients have not experienced recurrence of disease. The patients enrolled in the trials had all failed to achieve remissions with conventional cancer therapies (surgery, chemotherapy and radiotherapy). With this positive tumor response in the initial studies, investigators continued to study increased OncoRad dose. However, patients who were injected with 15 mCi of Yttrium 90 also experienced thrombocytopenia or a decrease in the number of platelets. To avoid this potentially dose-limiting side effect, Kavanagh combined the intraperitoneal injection of OncoRad with the intravenous injection of EDTA, a chelator often used for treating lead poisoning, in order to increase the total dose administered. With this co-administration, up to 30 mCi of the radioisotope Yttrium 90 have been given thus far on the experimental protocol without evidence of thrombocytopenia or any other serious side effects. The results suggest that even further dosage level increases are now possible. Thomas J. McKearn, M.D. Ph.D., president of Cytogen Corporation, noted that "With over 20,000 American women predicted to be diagnosed with ovarian cancer in 1991, and over half of them expected to die from it, Cytogen is very enthusiastic about these Phase I results." Once the maximum tolerated dose is established, Cytogen will pursue Phase II clinical studies in patients who are less advanced in their disease with the objective to demonstrate consistent therapeutic effects. Cytogen Corporation is a biopharmaceutical company which has developed proprietary systems for linking drugs and diagnostic agents to monoclonal antibodies in order to optimize the function of the antibody as a delivery vehicle. The company currently has six cancer imaging agents under development and two of these imaging agents, for colorectal and ovarian cancer are awaiting FDA marketing approval. Also in clinical trials are two cancer therapy agents. /delval/ -0- 11/18/91 /CONTACT: Laura M. Hahn of Cytogen, 609-987-8221/ (CYTO) CO: Cytogen Corporation ST: New Jersey IN: MTC SU: CC -- PH004 -- 1225 11/18/91 08:31 EST
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|Date:||Nov 18, 1991|
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