Immune Response BioPharma Files Amended FDA BLA for Remune.
* Per the FDA mandate the indication of Remune changes to therapeutic treatment of adults with HIV/AIDS and drops the requirement of the vaccine be taken together with antivirals as it has not been tested with the current standard of care triple cocktail antiviral drugs.
* Remune met the primary endpoint of the Spain STIR 2102 REMIT study. After reviewing all the data provided by the protocol and the independent statisticians, it is now evident that REMUNE shows a positive impact on controlling virus and that the study has met its primary endpoint (P=0.034).
* Remune met the primary endpoint of the Thailand 2101 study. There was a significant difference in changes in CD4+ T cell counts that favored the REMUNE treated group compared to the IFA treated group (p<0.05) using an AUC analysis. On average, for REMUNE treated subjects, CD4 T cell counts increased by 84 cells by Week 40, whereas the increase for the IFA control group was 38 cells by Week 40. The CD4 cell count change from baseline analysis also favored the REMUNE treated group.
* Remune increased CD4+ T cells white blood cell counts in the 806 Phase III study. A statistically significant difference by AUC analysis in CD4+ counts of 10.5 cells/uL favoring the REMUNE group (p = 0.05) was observed in the subgroup 806 study. Subjects in the HIV-1 Immunogen group had an increase in average CD4 cell count of approximately 10 x 106/L greater than the placebo group (P = .02) in the Phase III study.
* Remune is the most tested HIV/AIDS vaccine in history with a large & strong safety profile over 4,000 patients and 20,000 injections without any serious adverse events.
* Remune was granted FDA orphan pediatric designation on February 14th 2014. the Phase I (808 study) demonstrates the vaccine is safe for children and produced immune responses.
* The FDA previously agreed to use virologic & secondary bio-markers for approval & licensure of Remune
"IRBP has taken it's time to file a through response to the agency and after a complete review of the data Remune demonstrates not only safety but a clinical benefit to patients injected with the HIV-1 immunogen vaccine with increased white blood cells in the Remune group in study after study. It's trench warfare in the HIV drug/vaccine business with all of the conflicts of interest and money at stake. At the end of the day I am confident Remune will be approved by the FDA the easy way or the hard way. While I won't guarantee Remune is approved the outlook for the vaccine is positive & the data warrants approval with a large safety profile and strong immune responses," 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 100?g 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 safely to over 4,000 patients in over 20,000 injections with no adverse events & over 25 separate clinical trials, has an excellent safety profile, is well tolerated and is easy to administer via intramuscular injection in the left 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-naive 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. can be found @ www.immuneresponse.net
Immune Response BioPharma, Inc.
Contact via Email
Read the full story here: http://www.pr.com/press-release/683709
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|Publication:||PR.com (Press Releases)|
|Date:||Aug 18, 2016|
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