Immune Response BioPharma, Inc., (IRBP) has planned to seek emergency approval of Remune with a BLA filing in Europe as well begin stockpiling and manufacturing the HIV/AIDS vaccine once we have secured a corporate partner in the region. Europe will be an important set of countries and market in the Eurozone that IRBP plans to enter with an expansion of the HIV/AIDS vaccine Remune for marketing authorisation.
"IRBP has a clear plan of action to bring Remune to market and secure the marketing authorisations needed across the globe in key countries in need of this novel and blockbuster vaccine for HIV/AIDS. Countries and areas with the greatest need will come first such as Thailand and the continent of Africa and then make the vaccine available globally. The EMA is a well respected regulatory body and i am confident that Remune will secure emergency approval as the officials in Europe want a safe and effective vaccine immediately for use to combat this life threatheing disease. Remune is probably best the world is going to get in a vaccine thus it is imperative that patients have access to it asap," said Buswell CEO IRBP.
Remune is a therapeutic vaccine designed to elicit immune responses against a variety of HIV antigens in patients with HIV. It consists of a suspension of killed HIV-1 virus particles that have been emulsified with Incomplete Freund’s Adjuvant (IFA, a mixture of mannide mono-oleate and a highly purified mineral oil).
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. 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; work in Patients with Multi-Drug Resistance; 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, Reduce Viral Load, Increase CD4+ T cells & CD8+ T Cell Counts.