REMUNE has been Granted FDA Orphan Designation for Pediatric HIV/AIDS treatment in February 2014.
CD8+ T-cells are a critical component of the cellular immune response and they play an important role in the control of viral infection, memory cells established & retained, Memory CD8 T cells are an important component of protective immunity against viral infections such as HIV infections.
"IRBP will seek FDA approval for expanded use of Remune for monotherapy treatment of HIV/AIDS infected population. Remune produces strong increases in CD8+ T cells these white blood cells go in and kill the bad virus infected cells, this is very important to controlling viral load and virus replication. These are significant increases in these white blood cell counts in the Remune monotherapy study the Remune responder group produced on average, responders increased CD4+T cells by 134.00 cells/ul, CD8+ cells increased 295.25 cells/ul, these are significant green shoots of white blood cell counts. Remune should be utilized at the discretion of clinicians and not tied to HAART drugs, in fact the vaccine should be allowed to be given freely to any infected HIV/AIDS person without being forced to take toxic drugs with it, this is nonsense & criminal to keep this vaccine away from the HIV/AIDS population. Remune opponents appear to have some financial conflict of interest in keeping the vaccine off the market, either that or they are evil terrorists.
If the FDA fails to give HIV/AIDS population access to Remune IRBP is prepared to seek legal remedy with the DOJ and Federal Court, keeping Remune off the market is effectively manslaughter, the FDA needs to act responsibly here & help these people, it is irresponsible to continue keeping them hooked on toxic drugs, taking their money from them. Its an axis of evil led by big pharma which has run wild like a street crack dealer with HIV drugs. Only Americans wish to keep people sick to profit off them, this is how low our society has sunk, HIV/AIDS patients have suffered long big pharma nor our govt hasn't given them a break. REMUNE a first in class, best in class & vaccine of choice for HIV/AIDS Vaccines. " IRBP CEO Mr. Buswell commented.
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