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Immune Response BioPharma, Inc. to Seek FDA Breakthrough Designation of REMUNE HIV/AIDS Vaccine

Immune Response BioPharma, Inc. to Seek FDA Breakthrough Designation of REMUNE HIV/AIDS Vaccine for Pediatric Treatment & Plans Phase II Pediatric Study.

PRLog - May 5, 2014 - NEW YORK -- Immune Response BioPharma, Inc., Today Announces its plans to Seek FDA Breakthrough Designation of it's Flagship REMUNE HIV/AIDS Vaccine for Pediatric Treatment & Plans a new Phase II Pediatric Study.

FDA Breakthrough Designation: Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. A breakthrough therapy designation conveys all of the fast track program features (see below for more details on fast track designation), as well as more intensive FDA guidance on an efficient drug development program.

REMUNE has been Granted FDA Orphan Designation for Pediatric HIV/AIDS treatment in February 2014.

"REMUNE is a first in class & best in class HIV/AIDS therapeutic vaccine treatment. This is a very safe quarterly dosing therapeutic vaccine that will make treating pediatric HIV/AIDS safer & more tolerable for children who are innocent victims of this awful disease. As IRBP moves into further pediatric studies with a new Phase II pediatric study REMUNE vs placebo IFA in around 25-50 children, we will be filing for SBIR grant funding for the study later in 2014 by the due dates. We are committed to Remune development for both pediatric & preventative roles beyond therapeutic which has been demonstrated with over 25 clinical studies both safe and provides clinical benefit, given there is no currently available alternative to the HAART drugs REMUNE remains the only real viable vaccine option with nothing remotely even comperable to the vaccine in development or on the horizon, we will submit our BLA for Remune therapeutic vaccination when we have our application complete & we will take our time to ensure its accurate before its submission" commented IRBP CEO Mr. Buswell.

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.

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. 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.

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.

Immune Response BioPharma, Inc. Maybe Found on the World Wide Web @ www.immuneresponse.net

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Immune Response BioPharma, Inc.


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Source:Immune Response BioPharma, Inc.
City/Town:New York City - New York - United States
Industry:Biotech, Health
Tags:immune response biopharma, fda, REMUNE, hiv aids, vaccines
Last Updated:May 06, 2014
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