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12/27/2013 8:02:18 AM
PRLog (Press Release) - Dec. 25, 2013 - NEW YORK -- Immune Response BioPharma, Inc., Today Sets U.S. REMUNE Pricing Range $75-250 Per Dose with a Target of $100 or Less, Goal of $50 per dose, Once Commercial Manufacturing & Stockpiling on a Large Scale is Secured or a New Manufacturing Plant is Built.
IRBP Sets an initial Price Range for the HIV/AIDS Vaccine REMUNE between $75-250 per dose, dosing once every 3 months. Total Patients Costs, a Maximum out of pocket cost $1000 a year, before insurance coverage kicks in which should cover the majority of the treatment costs.
Currently IRBP relies on third party manufacturing for the vaccine which is a costly and timely expense as it takes multiple vendors to make REMUNE.
"IRBP is committed to saving lives not profits, the initial costs for REMUNE will vary and fluctuate until we build a new Level 3 facility capable of manufacturing the HIV/AIDS vaccine in house. Ultimately we would like to get the cost down to around $50 a dose for HIV/AIDS positive patients, we have no interest in profiting off of HIV infected individuals. REMUNE is a perfectly good HIV/AIDS vaccine and the honorable, ethical and right thing to do for HIV/AIDS patients is to let them have REMUNE which increases white blood cell counts both CD4+ & CD8+ T cells unlike the HAART drugs which kills the virus cells but also kills their normal cells. We will begin work on the next generation vaccine RemuneVax for preventative use once REMUNE is approved" Immune Response BioPharma, Inc, 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. A statistically significant difference by AUC analysis in CD4+ counts of 10.5 cells/uL favoring the REMUNE group (p = 0.05) was observed in a large multi-center Phase III study of REMUNE HIV/AIDS vaccine. Subjects undergoing treatment with REMUNE showed increased CD4+ & CD8+ T cell productions, 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 2,000 patients in over 25 separate clinical trials with over 17,000 injections safely adminstered, has an excellent safety profile, is well tolerated and is easy to administer via intramuscular injection in the deltoid muscle.
Data from clinical trials of Remune suggest that it may:
Induce a HIV-specific T-cell response; Increase CD4+ T cell production & counts A statistically significant difference by AUC analysis in CD4+ counts of 10.5 cells/uL favoring the REMUNE group (p = 0.05) was observed in a large multi-center Phase III study of REMUNE HIV/AIDS vaccine
Induce cytokines and chemokines, substances that interfere with the virus attaching to and infecting normal cells;
Work with antiretroviral drugs as a complementary treatment for HIV infection;
Work in drug-naïve patients to delay the need for initiation of HAART; and
Be safe with no adverse side effects.
Immune Response BioPharma, Inc. Maybe Found on the World Wide Web @ www.immuneresponse.net
Immune Response BioPharma, Inc.
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