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DOSE-RANGING STUDY SHOWS HIV IMMUNOTHERAPEUTIC STIMULATES ANTIBODY AND CELLULAR RESPONSES

 DOSE-RANGING STUDY SHOWS HIV IMMUNOTHERAPEUTIC STIMULATES
 ANTIBODY AND CELLULAR RESPONSES
 SAN DIEGO and COLLEGEVILLE, Pa., July 20 /PRNewswire/ -- The Immune Response Corporation (NASDAQ-NMS: IMNR) and Rhone-Poulenc Rorer Inc. (NYSE: RPR) presented today at the VIII International AIDS Conference the results of a dose-ranging study with their HIV immunotherapeutic. This clinical trial was conducted by a joint venture between the two companies to determine the ability of the HIV immunotherapeutic to stimulate an immune response at several dosage levels. The dose-ranging study has successfully demonstrated that the HIV immunotherapeutic significantly stimulated antibody and cellular immune responses in treated patients as compared with control patients.
 The study was designed to evaluate the ability of the product to stimulate an immune response. The study was not designed to evaluate, and there is no evidence to indicate, the effectiveness of treatment or the ability of the product to cure AIDS. A separate Phase II/III clinical trial, currently ongoing, is the study designed to determine the efficacy of the HIV immunotherapeutic. That double- blind, placebo-controlled Phase II/III clinical trial will end late this year.
 Study Design
 The patients enrolled in this study were HIV-infected but had no signs or symptoms of AIDS or AIDS-related conditions. Four dosage levels of the HIV immunotherapeutic were tested: 50 micrograms (mcg), 100mcg, 200mcg and 400mcg. Each dose consisted of an envelope-depleted, inactivated virus preparation mixed with an adjuvant, a substance which elicits a more potent immune response by more effectively presenting the inactivated-virus proteins to the immune system. Patients who received the HIV immunotherapeutic were compared with a group of patients who received a control, the adjuvant alone. The study was designed to compare antibody and cellular responses in patients receiving the HIV immunotherapeutic at each dosage level with the responses in patients receiving the adjuvant alone.
 Results
 Treated patients in this study demonstrated cell mediated or antibody responses to a significantly greater degree than patients receiving the adjuvant control. A dose response was seen in both parameters, indicating that the appropriate range of doses had been tested.
 Antibody responses were measured by two methods, one which qualitatively indicates broad-based immune responses to several HIV proteins, and a second method which quantitatively measures responses against p24, a core protein of HIV. The qualitative method indicated that the HIV immunotherapeutic stimulated broad-based antibody responses against HIV proteins in several treated patients. The quantitative method demonstrated up to 64-fold increases in antibody responses directed against the p24 core HIV protein. The magnitude of antibody responses in the treated patients was significantly greater than in the control patients. Patients with low baseline antibody titers at study entry responded more strongly to treatment than patients with higher baseline antibody titers.
 Cellular responses against HIV were measured by a skin test, similar to a tuberculosis skin test, which indicates the ability of T cells to respond to HIV proteins. Patients treated with the HIV immunotherapeutic in this study had significantly stronger skin test responses than the control patients.
 The dose-ranging study also evaluated the safety of treatment with multiple doses of the HIV immunotherapeutic. Two-hundred seventy-two inoculations of the product or the adjuvant control were administered to 48 patients in this study, receiving up to six inoculations each, without any serious adverse effects. No patients dropped out of the study as a result of adverse experiences.
 Conclusion
 The results of this study demonstrate, in a statistically significant manner, that the HIV immunotherapeutic can stimulate enhanced immune responses in HIV-infected patients. One hundred mcg of the HIV immunotherapeutic was the lowest dose to stimulate a statistically significant immune response. The product was well tolerated at all dosage levels.
 A separate Phase II/III clinical trial, which is continuing, is designed to evaluate the effect of treatment with the HIV immunotherapeutic on multiple markers for disease progression. The Phase II/III clinical trial remains blinded and is expected to end late this year. Data from the Phase II/III trial cannot be analyzed until the trial is completed and has been unblinded.
 The Immune Response Corporation is a biopharmaceutical company engaged in the development of proprietary products for the treatment of HIV infection, which leads to AIDS, and for the treatment of certain autoimmune diseases, particularly rheumatoid arthritis, multiple sclerosis and insulin-dependent diabetes.
 Rhone-Poulenc Rorer Inc. is a global pharmaceutical company dedicated to the discovery, development, manufacturing and marketing of human pharmaceuticals. RPR had annual sales of $3.8 billion in 1991 and plans to invest more than $500 million in research and development in 1992.
 -0- 7/20/92
 /CONTACT: Steven Basta of The Immune Response Corporation, 619-431-7080, ext. 3332; or Jane Green of Rhone-Poulenc Rorer, 215-454-3871/
 (IMNR RPR) CO: The Immune Response Corporation; Rhone-Poulenc Rorer Inc. ST: California, Pennsylvania IN: MTC SU:


KJ-AL -- SD002 -- 0546 07/20/92 08:05 EDT
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Publication:PR Newswire
Date:Jul 20, 1992
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