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Immune Response BioPharma To File Remune BLA With FDA By March 1st 2014 Submits Fee Waiver Request
12/3/2013 8:32:16 AM
Dec. 3, 2013 - NEW YORK -- Immune Response BioPharma, Inc. Today Announces its will File a BLA for Remune Approval with the FDA by March 1st 2014 Once our Fee Waiver Request is Approved.
* Immune Response BioPharma is submitting its request to waive the establishment fees for the Remune BLA under SBA rules for the first drug/biologics application fee waiver for small biopharmas such as IRBP.
* IRBP is initiating the BLA filing and recommending to the FDA the immediate unmet medical need for approving Remune so patients will have access to the HIV/AIDS vaccine.
* IRBP expects funding for manufacturing and big pharma partnering to materialize once the FDA approves the BLA for Remune and a 6-9 month timeframe to manufacture the first commercial batch of the vaccine for patients use.
* IRBP expects the FDA to vote on Remune approval by the end of 2014 or early 2015.
* IRBP to Transition Remune to a Preventative Role & Pediatric Use
* IRBP to Initiate Phase III IR103 RemuneX Study Remune + Amplivax a more Potent HIV/AIDS Vaccine
"Remune whole killed vaccine technology is a perfectly good HIV/AIDS vaccine and the only viable vaccine to date developed by Salk a thought leader who has a track record in vaccines with the flu and polio and is the tried and true method of developing vaccines for the last fifty years. Remune has been proven very safe & shown to have clinical benefit in over 25 clinical studies and has many benefits that patients have been denied access to by some very selfish conflicts of interests, patients have been forced to take toxic drugs with no relief or other options which is quite unfortunate" commented IRBP CEO Mr. Buswell.
"Conflicts of interest that have kept Remune off the market include billions of dollars at stake for HAART drugs, research dollars, an entire industry of jobs built on "searching for a cure" researchers jealous of Salk getting credit for both Polio and HIV/AIDS Vaccines and numerous other conflicts of interest to keep Remune out of patients hands" further commented IRBP CEO Mr. Buswell.
"It is time to bring Remune to market and help patients and approve the vaccine immediately. Transitioning the vaccine to preventative use is also the right thing to do and will be one of the next steps for the vaccine to utilize it in the preventative role where the whole killed technology is best suited for. It is also important to further explore the use of Remune in the pediatric treatment setting to help children" futher commented IRBP CEO Mr. Buswell.
"Finally i expect the FDA advisory panel to vote 5-4 in favor of approving Remune as they will want to give patients access to the vaccine and not deny them the treatment option. Keeping Remune out of HIV/AIDS patients hands is like telling people who get the flu they can't have a flu shot its disgraceful and appalling the USA is 0-26 years in developing a vaccine for this terrible disease. Its a very bad virus and you can't beat it with drugs alone nor can you defeat it with these weird mouse antibody concoctions researchers are pushing its not realistic. Those who oppose Remune if they had the HIV/AIDS disease would be the first ones in line demanding the vaccine. What vaccines have they ever developed? IRBP is #1 and the USA will lead with the first HIV/AIDS vaccine anyone who opposes its approval is a sick depraved selfish individual. I am proud of the work i have done to rebuild Immune Response into a winner" further 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
Immune Response BioPharma
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