Pharmabiz
 

Immune to seek emergency approval of Remune in Thailand; to begin stockpiling HIV/AIDS vaccine

New YorkWednesday, April 24, 2013, 12:00 Hrs  [IST]

Immune Respone BioPharma, Inc. (Immune), a leading vaccine development company, will seek emergency approval of Remune in Thailand as well begin stockpiling and manufacturing the HIV/AIDS vaccine after signing an agreement with the Thailand officials. Remune is a therapeutic vaccine designed to elicit immune responses against a variety of HIV antigens in patients with HIV.

Remune 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.

 
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