Immune Response BioPharma to Seek Approval of REMUNE With MCC of South Africa
6/18/2013 8:36:39 AM
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PRLog (Press Release) - Jun. 17, 2013 - NEW YORK -- Immune Response BioPharma, Inc., has notified the Dept of Health & MCC of the Republic of South Africa that IRBP will Seek Emergency Approval of REMUNE in S.A. as well begin stockpiling & manufacturing the HIV/AIDS vaccine once we have secured a corporate partner in the region. South Africa will be the second country and market in the African Continent that IRBP plans to enter with the HIV/AIDS Vaccine REMUNE.
Overseas Countries & Corporate Partners interested in licensing REMUNE from Immune Response BioPharma, Inc. should contact us @ email@example.com or Dr. Jeffrey Taylor of NW Clinical Research @ www.nwclinicalresearch.com
"REMUNE is ready to go to market and will help save millions of lives in the African continent its been tested safely more than any drug or vaccine in history and is a fairly effective vaccine for such a terrible disease producing strong immune responses & clinical benefit. When you have people dying at a rapid clip you have to take action to help these people and this country with a quick response as a responsible vaccine developer that is exactly what we are going to do for South Africa & bring REMUNE to market and begin treating the population expediently. Corporate partners are lining up to work with IRBP and our team is excited to finally bring the first HIV/AIDS Vaccine to commercialization" Mr. 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.
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
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