New York, NY, February 13, 2015 --(PR.com)-- Immune Response BioPharma, Inc., today announces receipt of Remune FDA BLA Assignment PDUFA goal date of December 22nd 2015 for Therapeutic HIV/AIDS Vaccine.
The FDA previously granted Remune FDA Pediatric Orphan Designation in February of 2014. http://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm?Index_Number=420113
The FDA & SBA waived the filing fee for the Remune BLA in early 2014 & IRBP submitted its BLA for therapeutic HIV/AIDS vaccination treatment on December 19th 2014.
The FDA has indicated a PDUFA Goal Date of December 22nd 2015 in its letter dated January 20th 2015.
"Remune is a first in class, & best in class vaccine, & vaccine of choice for HIV/AIDS Vaccines. The FDA did the right thing with this BLA assignment PDUFA goal date of December 22nd 2015, for the HIV/AIDS population to give them access to the vaccine. I thank the FDA for coming around on Remune, I applaude the agency for getting serious about helping give people with HIV an alternative to toxic drugs, hopefully it goes up for a quick vote in the fall to help the public with this awful disease," 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 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
Contact:
Immune Response BioPharma, Inc.
David Buswell
917-275-7931
Contact
www.immuneresponse.net
Help employers find you! Check out all the jobs and post your resume.
The FDA previously granted Remune FDA Pediatric Orphan Designation in February of 2014. http://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm?Index_Number=420113
The FDA & SBA waived the filing fee for the Remune BLA in early 2014 & IRBP submitted its BLA for therapeutic HIV/AIDS vaccination treatment on December 19th 2014.
The FDA has indicated a PDUFA Goal Date of December 22nd 2015 in its letter dated January 20th 2015.
"Remune is a first in class, & best in class vaccine, & vaccine of choice for HIV/AIDS Vaccines. The FDA did the right thing with this BLA assignment PDUFA goal date of December 22nd 2015, for the HIV/AIDS population to give them access to the vaccine. I thank the FDA for coming around on Remune, I applaude the agency for getting serious about helping give people with HIV an alternative to toxic drugs, hopefully it goes up for a quick vote in the fall to help the public with this awful disease," 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 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
Contact:
Immune Response BioPharma, Inc.
David Buswell
917-275-7931
Contact
www.immuneresponse.net
Help employers find you! Check out all the jobs and post your resume.
