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Immune Response BioPharma, Inc. TM            Copyright  © 2010-2019





IRBP Amended Remune BLA Filed with FDA 08/06/2016   Remune U.S. Govt License #2013  Pediatric Booster BLA Filing 10/23/2017

 Remune 2015 FDA BLA Data Clinical Dossier 

REMUNE TM HIV-1 Immunogen: FDA BLA Filing a First in Class & Best in Class HIV/AIDS Vaccine, a First Line  Rescue Therapeutic Safe & Effective Life Saving HIV/AIDS Vacccine, Dosing 100ug every 3 months New Dosing Formulations: 25ug Once Weekly, 100ug Once Monthly & 400ug Every 3 Months

02/15/2014 U.S. Non Provisional Patent Application Filing #14181628

Whole Killed GP120 Depleted Vaccination & Methods in IFA Against HIV/AIDS Diseases in Humans

REMUNE Featured in Walgreens 2014 Pipeline Report      REMUNE Granted FDA Orphan Designation for Pediatric HIV/AIDS Therapeutic Vaccination

Orphan Drug List 2014  REMUNE Featured in 2014 PhRMA Research Report      REMUNE Pediatric Phase II Study 

REMUNE TM NIH Trial Article


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.




REMUNE is a rescue treatment for HIV/AIDS stabilizing CD4+ T cell counts and increasing production of CD4+ & CD8+ T cells (White Blood Cell Counts). The administration of inactivated virus may stimulate humoral and cellular immune responses, which may slow the replication of HIV-1 through increased immunologic control over infected cells or other as yet undetermined mechanisms. The use of inactivated virus could theoretically stimulate broader immune responses that are capable of suppressing more diverse strains of HIV than vaccines based on sub-units of the virus. REMUNE for Treatment of Multi-Drug Resistance in patients with HIV. Transitioning REMUNE to a Preventative Vaccine for those at risk of contacting the disease or in South Africa where a preventative vaccine treatment is necessary where the risk to reward ratio favors vaccination with a whole killed vaccine approach. The REMUNE technology can be used to develop a yearly HIV/AIDS vaccine with the current mutated strain of the virus to knockout this disease globally.




These previous clinical studies of REMUNE®have demonstrated distinct clinically additive benefits in both immunologic and virologic parameters in HIV-1 infected individuals undergoing treatment including increased production of CD4+ & CD8+ T cells (White Blood Cell Counts). Subjects undergoing treatment with REMUNE®showed improvements in percentage of CD4 cells, HIV-1 DNA in PBMCs, and weight. An augmentation of cellular immune responses has also been demonstrated, as measured by lymphocyte proliferation to HIV-1 and p24 antigens, as well as greater DTH reactivity to HIV-1 antigen. HIV-1 DTH reactivity in immunized subjects has also been shown to correlate with a more favorable clinical course. Previous studies also indicate that REMUNE®can safely be given in combination with antiviral drugs. REMUNE patient reports his HIV/AIDS virus level was undetectable while on REMUNE "Undetectable".


REMUNE Phase III Study 806 Conclusions: 

  • REMUNE halted & arrested the HIV/AIDS disease progression demonstrating a safe & clinically effective vaccine when compared under the original clinical endpoints with disease progression rates much lower than the annualized CDC defined event rate using the original diagnoses of clinical endpoints of 6% projected: with actual results of .07% less than 1% the original endpoint, expanded endpoints 1.4%. Although no differences were seen in the expanded clinical primary endpoints of AIDS, disease progression or deaths more than half the events would have been excluded under the original endpoint which demonstrates strong clinical efficacy of Remune, this may be explained by the expanded clinical endpoints additions making the sample size no longer large enough, also IFA a very strong adjuvant may have stimulated the protease inhibitors & HAART drugs to boost their effectiveness in the placebo group. The use of protease inhibitors may have reduced the hiv infections and mortality and morbidity of subject in the study. Irregardless the combination of HAART drugs and REMUNE effectively shutdown the HIV/AIDS progression and there was no reason to halt the study early and three years into a big Phase III multi-center study, and a convenient reason to raise with DSMB once the results were going too well in favor of the REMUNE vaccine in the study. The common denominator in both groups was the use of IFA and protease inhibitors along with HAART drugs this may explain why both groups fair'd well but the significant immune responses, reduction in virus level and CD4+ T-Cell counts were demonstrated only in the REMUNE group. 
  • In summary Remune was clinically beneficial to the patients receiving the vaccine for more than two years before the study was changed to add additional therapies thus the original endpoint and study was a success and demonstrated the vaccines effectiveness in halting & delaying disease progression or deaths.

  • A statistically significant difference by AUC analysis in CD4+ counts of 10.5 cells/uL favoring the REMUNE group (p = 0.05) was observed although no CD4+ % differences were seen between the groups both REMUNE & IFA groups saw increased CD4+ T-Cell counts and a reduction in virus level. The increased production of CD4+ T cells stimulated by REMUNE is very important in fighting off the HIV virus because once a patients immune system CD4+ T cell counts fall below 200 they become susceptible to full blown AIDS as the CD4+ T cells can no longer effectively signal the CD8+ T cells to kill the infected HIV virus cells, this will ultimately lead to the HIV virus overwhelming the immune system resulting in fatality. The normal range of white blood cells is 4,500-11,000 per microliter, (a microliter is one millionth of a liter) and on average humans have about 5 liters of blood, 10.5 cells/uL = 10,500,000 additional white blood cells per liter * 5 liters = 52,500,000 additional white blood cells to fight off virus. The significant increase in CD4+ T cell counts produced by REMUNE warrants its use a first line defense in HIV/AIDS treatment. Turner et al  

  • REMUNE treated patients saw significantly greater increase in Immunity & LPA Lymphocyte proliferation and np24 antigens (p = 0.001) was observed in the REMUNE group compared to IFA subjects. REMUNE elicited an enhancement of B-chemokines emanating from CD8+ T cells Lymphocytes was observed, this is a very important and significant  as the CD8+ T cells destroy virally infected cells & kill the HIV virus.

  • REMUNE was well tolerated systemically and safely with patients experiencing mostly local site injection reactions. There was no adverse treatment events reported in the REMUNE group.

  • Subjects treated in the REMUNE group of the 252 patient sub group study analysis had significantly greater decline in viral load at multiple time points (P < 0.05) a trend towards increased CD4+ T cell counts, and significantly enhanced HIV-1 immune responses as measured by HIV-1 lymphocyte proliferation with (P < 0.001), and  demonstrated a 20 week time difference to median time of virologic failure favoring the REMUNE group with analysis REMUNE at 102.9 weeks vs IFA at week 83, although no statistically significant difference was seen. Turner et al

  • The early termination of the 806 REMUNE study was not based on safety issues of REMUNE and the expansion of clinical endpoints were accommodated. The changing of endpoints once a study is underway is rare and  unusual, the repeated interference in the study by investigators because it was going too well in favor of the REMUNE vaccine is puzzling, to change endpoints in the middle of the study and then having DSMB stop the study three years into it is bizarre and troubling & disturbing by investigators which raises the questions of ethics, conflicts of interest and moral responsibility to patients & the public in this clinical study. There is and was no valid safety or lack of clinical benefit reason to have halted the study early other than to attempt to manipulate the results in a negative light against the effectiveness of the vaccine and its role in the treatment of HIV/AIDS constitutes fraud. The lead investigator's actions in this study resembles that of a hit-man for big pharma. When billions of dollars are at stake and a real treatment like REMUNE comes along no doubt the conflicts of interest rear their ugly heads. Basically big pharma fears REMUNE because it works too well and it threatens the gravy train of profits when you have patients hooked on drugs like HAART for life.

  • The role of REMUNE should be considered a vital part of any course of treatment for HIV/AIDS as it has produced increases in CD4+ T cell counts extending survival rates and it borderlines on criminal actions to keep the vaccine off the market and out of patients reach is cruel and unusual punishment.Those who do not want patients to have REMUNE are selfish interests which if they had the disease would be the first ones begging for the vaccine and a much safer tolerable treatment than being sentenced to a life of toxic drugs. Dr. John Turner of the Philadelphia Hospital who enrolled the majority of patients for the study who believes REMUNE can halt HIV progression stated "If i were HIV-positive, I would batter down any door necessary to get it, period".

806 STUDY CHARTS RNA VIRAL LOAD, CD4+ T cell Counts & LPA Lymphocytes Favoring the REMUNE Groups JL Turner et al

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;


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.

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