IRBP Seeks Emergency Approval of Remune In Zimbabwe
On 3rd June 2013, Immune Response BioPharma (IRBP) notified the MCAZ of Zimbabwe that the company will seek emergency approval of Remune (HIV-1 immunogen) in Zimbabwe, as well as begin to stockpile and manufacture the HIV/AIDS vaccine once IRBP has secured a corporate partner in the region. Zimbabwe will be the first country and market in South Africa that IRBP plans to enter with Remune.
Remune is a therapeutic vaccine designed to elicit immune responses against a variety of HIV antigens in patients with the virus. It consists of a suspension of killed HIV-1 virus particles that have been emulsified with Incomplete Freundâs Adjuvant (IFA). 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 IFA at 1:1 ratio. Each 1mL dose (at least 100mcg or 10 U) has viral protein and p24.
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 peripheral blood mononuclear cells and weight. Previous studies also indicate that Remune can safely be given in combination with antiviral drugs.
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.