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TECHNOLOGY OVERVIEW HIV -REMUNE®
Manufacturer : The Immune Response Corporation, San Diego, CA, USA Product Description: REMUNE® is derived from Zairian HIV-1 strain HZ-321, composed of gp120-depleted HIV-1 propagated in HUT-78 cells and inactivated in beta-propriolactone and irradiation. The inactivated material is emulsified with mineral oil (Incomplete Freund's Adjuvant) at 1:1 ratio. Each 1 ml dose (at least 100μg or 10 units) has viral protein and p24. Potential Benefits of this Technology: Administration of inactivated virus may stimulate cellular immune responses, which may slow the replication of HIV-1 through increased immunologic control over infected cells or other as yet undetermined mechanisms. The use of inactivated virus could theoretically stimulate broader immune responses that are capable of suppressing more diverse strains of HIV than vaccines based on sub-units of the virus. REMUNE® may work with currently available antiviral drugs (AZT, ddI, ddC, and protease inhibitors) as a complementary treatment for HIV infection. The Company believes that while antiviral drugs interrupt the reproduction process of HIV within infected cells, REMUNE® stimulates the immune systems to destroy HIV-infected cells. In Thailand, the results of REMUNE® clinical trials showed that it is safe and well tolerated. No serious adverse events were reported during the conduct of the studies. The use of REMUNE® in HIV infected Thai patients sustains or increases CD4+ cell counts thus delaying the use of antiretroviral drugs. Further, the genotypic drug-resistance study done in volunteers showed no drug mutation in REMUNE® treated group, thereby delaying the progression of HIV infection to AIDS. Past USA Trial Results: These previous clinical trials of REMUNE® have demonstrated distinct benefits in both immunologic and virologic parameters in HIV-1 infected individuals undergoing treatment. Subjects undergoing treatment with REMUNE® showed improvements in percentage of CD4 cells, HIV-1 DNA in PBMCs, and weight. An augmentation of cellular immune responses has also been demonstrated, as measured by lymphocyte proliferation to HIV-1 and p24 antigens, as well as greater DTH reactivity to HIV-1 antigen. HIV-1 DTH reactivity in immunized subjects has also been shown to correlate with a more favorable clinical course. Previous studies also indicate that REMUNE® can be safely given in combination with antiviral drugs. 425/129 Silom 5, Silom Road, |
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[PRODUCT] [RESEARCH & DEVELOPMENT] [CONFERENCE ABSTRACTS] [REMUNE PUBLICATIONS (THAILAND)] |
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