Jul. 14, 2014 - NEW YORK -- Immune Response BioPharma, Inc., Today Posts Record 1st Half 2014 Results Blockbuster HIV/AIDS Vaccine REMUNE set to become first HIV/AIDS Vaccine to file for FDA BLA Approval & come to market.
IRBP First Half 2014 Highlights:
• NeuroVax Flagship MS Vaccine Granted FDA Fast Track Designation for SPMS
• NeuroVax Granted FDA Pediatric Orphan Designation
http://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm?Index_Number=385412
• NeuroVax New Phase IIb Study & IND Approved by FDA, IRBP is seeking NIH Grant Funding for the Studies.
http://clinicaltrials.gov/ct2/show/NCT02057159?term=neurovax&rank=1
http://clinicaltrials.gov/ct2/show/NCT02149706?term=neurovax&rank=1
• REMUNE Flagship HIV/AIDS Vaccine Granted SBA/FDA BLA Fee Waiver
• REMUNE Flagship HIV/AIDS Vaccine Granted FDA Pediatric Orphan Designation
http://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOP...
• IRBP Announced Plans for a New Pediatric REMUNE Phase II Study & FDA Breakthrough Designation Application IND to be filed with FDA
• IRBP Executed Two New CDA’s with mid size Pharmaceutical companies
• IRBP Selected Seppic to provide IFA for Remune Commercialization & clinical pipeline
• IRBP Plans new Psoriasis Vaccine Phase IIb Study as Development on Track for Zorcell & DermaVax formulations as Dr. Gyulai of University of Pecs Tentatively agrees to be lead investigator for psoriasis vaccine development, IRBP seeking NIH Grant Funding for the study.
IRBP 2nd Half 2014 Guidance:
* IRBP to Submit New IND Application for FDA Breakthrough Designation for REMUNE for Pediatric HIV/AIDS Vaccination studies
• IRBP to submit its BLA for REMUNE for Therapeutic HIV/AIDS Vaccine for Marketing Authorization & Approval with the FDA & use SBA/FDA fee waiver
• IRBP to submit its Grant applications for NeuroVax, REMUNE, Zorcell/DermaVax new studies with NIH & SBIR
• IRBP to Initiate REMUNE Phase II Pediatric Clinical Study Planning & submit clinical study protocol to the FDA for study approval
• IRBP to Initiate NeuroVax Phase I Pediatric Clinical Study Planning & submit clinical study protocol to the FDA for study approval
• IRBP to Seek Strategic Partners for NeuroVax Development & REMUNE Partnering for Commercialization of the HIV/AIDS Vaccine.
• Prepare for our NeuroVax Phase IIb SPMS Study NeuroVax vs placebo upon NIH Grant Funding Approval for the study
“IRBP has had a record 1st half of 2014 as we moved the clinical pipeline forward and set many milestones for both REMUNE & NeuroVax vaccines. I am proud of the work our team has done its a total team effort to move the pipeline ahead although we have much work left to do to achieve our goals of getting both REMUNE & NeuroVax to the finish line. REMUNE is perhaps the most important vaccine in history its invaluable to the HIV/AIDS positive population to have access to the vaccine is critical and matter of survival for many without the toxic effects of the HAART drugs. I urge the FDA to continue to cooperate with IRBP to bring the first HIV/AIDS Vaccine to market & save lives. We look forward to filing the BLA with the FDA for Remune’s Approval in the 2nd half of 2014. REMUNE a first in class & best in class & vaccine of choice for HIV/AIDS Vaccines” IRBP CEO Mr. Buswell commented.
“I believe REMUNE is superior to the drugs and it is criminal to deprive (patients) them of it. The FDA has the ball in their court we are going to serve it back and file for the BLA FDA approval when our application is complete. If i had HIV i would knock down any door to get access to REMUNE i wouldn’t be duped into taking toxic drugs for the rest of my life, this whole industry is built on fraud & scaring the public & lying to them to keep them hooked on drugs so big pharma can keep the gravy train going. I would demand my REMUNE if i were HIV positive no way would i keep popping this toxic stuff indefinitely, you’re trading one set of problems for an even bigger set of problems down the road i dont know anyones immune system that can tolerate toxic drugs for life, REMUNE can be a big help & boost to the public anyone who had this virus would be begging for REMUNE like a dog & wouldn’t stand for taking drugs their whole life” IRBP CEO Mr. Buswell further 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
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