REMUNE has been Granted FDA Orphan Designation for Pediatric HIV/AIDS treatment in February 2014.
"IRBP plans to develop its own sales force for REMUNE HIV/AIDS Vaccine once the FDA approves our BLA application. Once approved and cleared for marketing authorization by the FDA the teller window will open for us we may go it alone or partner with several big pharma players. We have an infrastructure in place to handle CGMP manufacturing with a total of six vendors. We may outsource REMUNE sales to leading CRM sales force organizations, the vaccine will be sold out quickly i predict, we won't be able to meet initial demand, we may not need much help the vaccine will sell itself. Those who bet against IRBP will lose and lose badly especially those big pharma hiv drug makers they are like the dinosaur soon headed to extinction, they are goners & doomed once REMUNE is approved. I would get off those drugs if i had HIV once REMUNE is available they are risky & too toxic to take indefinitely"
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.
PAST USA TRIAL RESULTS:
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
Immune Response BioPharma, Inc. Maybe Found on the World Wide Web @ www.immuneresponse.net
Immune Response BioPharma, Inc.