IRBP's new HIV/AIDS preventative vaccine formulation IR-2020 RemuneVax TM will revolutionize the way HIV/AIDS vaccines are developed using the current year mutuated HIV strain with our proprietary whole killed HIV vaccine technology REMUNE.
IRBP will begin work on the new vaccine in 2015 once REMUNE for therapeutic treatment has been approved by the FDA. IRBP is on track to file its BLA with the FDA in early 2014.
"This is an exciting time for IRBP as we move REMUNE to the finish line armed with clinical data from over 25 clinical studies & trials we are confident IRBP will be the first biopharma to market with the first commercially available HIV/AIDS vaccine, it is unethical & criminal to keep REMUNE out of reach of HIV/AIDS patients. Our BLA filing for REMUNE with the FDA is on track we will be first to market with an HIV/AIDS vaccine. We plan to transition REMUNE to preventative studies and develop our new HIV vaccine IR-2020 RemuneVax a once a year preventative vaccine based on the current mutated HIV strain, demonstrating why IRBP is quickly becoming the #1 vaccine development company in the world" Immune Response BioPharma 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 increased CD4+ 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, 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;
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