NEW YORK -- Immune Response BioPharma, Inc., Today provides an update on the Remune BLA FDA filing and is in receipt of a refuse to file letter from the agency along with IRBP & the FDA's meeting results which suggests the BLA filing could continue under a protest filing and a complete response letter would probably be issued, then giving IRBP time to cure the deficiency and a constructive path forward.
The FDA indicated manufacturing of commercial Remune finished release batch lot info would be required for licensure, reformatting of the BLA with the clinical data reorganized, and the BLA fee waiver would remain in place.
The FDA further indicated it would respond back to IRBP's request for a ruling on the Remune Phase III study original clinical endpoint as the criteria for approving the HIV vaccine of the CDC defined 6% disease progression or deaths for licensure of the vaccine for therapeutic HIV in adults, Remune final endpoints were 1% original endpoint and around 1.7% expanded clinical endpoints. As well the FDA will provide clarity on the BLA fee waiver in the event of a complete response letter whether the fee waiver will be kept in place when IRBP cures the deficiencies and resubmits the filing.
"IRBP thanks the FDA for allowing us to continue forward with our Remune BLA filing, we ask the government to be fair and ethical for the HIV positive population. The meeting with the FDA was constructive and we now believe there is a path forward for Remune. We also believe there will be an opportunity to secure the manufacturing capital to move the HIV vaccine to the finish line. IRBP will determine whether to continue with the filing or withdraw and refile once the manufacturing of the new commercial Remune HIV vaccine finished release lot batches are complete. Depending upon the BLA fee waiver reinstatement it may make sense to withdraw the application and then refile once we have the new submission in order with the commercial Remune batches on hand. We are awaiting FDA rulings on the fee waiver and the Phase III original clinical endpoint to be used as the critieria to approve the vaccine for licensure which IRBP believes is the proper way to judge the vaccines efficacy. IRBP is committed to cooperating with the FDA and moving Remune to approval" IRBP CEO Mr. Buswell 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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