Immune Response Bio FDA BLA Update HIV Clinicians “Remune Repeatedly Immunogenic”
*IRBP had it’s meeting with the FDA in November 2016 where leading HIV clinicians Dr. Mario Clerici MD of Italy gave his opinion to the agency, “Remune has been shown over and over to be very immunogenic and to be able to elicit strong HIV- cell mediated immune responses”
*Study 215 led by internationally recognized HIV expert clinician Dr. Clerici MD Results from this study suggest a stabilization of CD4 counts over 28 weeks in subjects receiving three injections of REMUNE compared to control groups. Conclusions significant changes in CD4+ T cells at week 28 favored the Remune group (p < .06) at weeks 28 demonstrating after several injections clinical benefit to subjects immunized with HIV-1 Immunogen Remune.
*Additionally leading renowned HIV researcher, thought leader & clinician Dr. Fred Valentine MD of NYU provided his opinion to the agency verifying Remune immunogenicity at the FDA meeting noting the 816 study results where the vaccine demonstrated strong immune responses.
*816 study Results: By week 32 the group receiving HAART plus Immunogen had a significantly higher response rate for lymphocyte proliferation to purified native p24 (p= 0.0002), gp120 depleted HZ321 HIV-1 (p=0.005), and whole BaL (p=0.007) antigens compared to the group receiving HAART plus IFA which did not develop LPR to HIV antigens. The production of antigen stimulated MIP-1 was also augmented in the HAART plus Immunogen group (p=0.0007).
* Per the FDA mandate the indication of Remune changes to therapeutic treatment of adults with HIV/AIDS to elicit immune responses against a wide variety of HIV-1 antigens 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.
* Phase IIb 2102 Study: 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).
* Phase IIb 2101 Study 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.
* Phase III 806 Study: 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) clinical benefit 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 × 106/L greater than the placebo group (P = .02) in the large Phase III multi-center study 2,500 subjects.
* 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
*”Remune is without a shadow of doubt it is the defacto HIV vaccine. I am pleased the leading HIV researchers & clinicians who used Remune to treat their patients stepped forward & provided an accurate opinion on the vaccine to the FDA. The Salk vaccine HIV-1 immunogen is best immune based vaccine. As we separate the noise from reality Remune is a true HIV vaccine with verified data of robust immune responses & clinical benefit was demonstrated. The agency should quickly move to convene an advisory panel meeting & a vote in favor of Remune for approval is warranted. IRBP demands fairness from the government & media to recognize Remune is a safe first in class & best in class HIV vaccine and deserves approval,” IRBP CEO Mr. Buswell commented.
Immune Response BioPharma, Inc. can be found @ www.immuneresponse.net