PRLog (Press Release) - Jun. 20, 2014 - Immune Response BioPharma, Inc., Today announces it Selects Seppic to Supply Commercial Quantities of Incomplete Freund’s Adjuvants IFA for REMUNE HIV/AIDS Vaccine Commercialization & clinical development pipeline.
MONTANIDE ISA 51 VG is a vaccine adjuvant composed of a light mineral oil and a surfactant system designed to make a water-in-oil emulsion.
It has been used since 1992 in more than 150 clinical trials related to therapeutic vaccines against various diseases such as cancer, HIV and autoimmune diseases.
MONTANIDE ISA 51 VG has proved to be a very efficient adjuvant, activating the cellular and the humoral immune response. It has been administered to more than 10,000 patients throughout the world.
SEPPIC ensures a complete GMP process for the manufacture of its adjuvants, from raw materials to QA batch release. Sterile grades are manufactured under aseptic conditions in a pharmaceutical facility.
“IRBP is going with the proven leader in vaccine adjuvants Seppic for commercialization quantities of IFA for the REMUNE HIV/AIDS vaccine once approved for therapeutic use by the FDA. Seppic has agreed in principle to provide commercial quantities of IFA for REMUNE manufacturing. Seppic will also supply IRBP with IFA adjuvant for the clinical pipeline development including NeuroVax for MS. I am personally committed to helping HIV/AIDS patients get access to the REMUNE vaccine it is really sad, unfortunate & criminal that they are being deprived of this rescue life saving vaccine & forced to stay hooked on drugs for life they deserve some relief. IRBP thanks Seppic for cooperation in commercial manufacturing of REMUNE a first in class & best in class & vaccine of choice for HIV/AIDS Vaccines” IRBP CEO Mr. Buswell.
REMUNE is derived from Zairian HIV-1 strain HZ-321, composed of gp 120-depleted HIV-1 propagated in HUT-78 cells and inactivated in beta-propiolactone 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.
These previous clinical studies 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 safely be given in combination with antiviral drugs.
IR103/Remune,unlike antiviral drugs, can induce an HIV-specific response, which is now thought by numerous researchers to be important in controlling HIV replication. Remune has been administered to over 3,000 patients, 18,000 injections in over 25 separate clinical trials, has an excellent safety profile, is well tolerated and is easy to administer via intramuscular injection in the deltoid muscle.
Seppic a leader in vaccine adjuvants can be found @ www.seppic.com
Immune Response BioPharma, Inc. Maybe Found on the World Wide Web @ www.immuneresponse.net
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