The FDA Office of Orphan Products Development (OOPD) mission is to advance the evaluation and development of products (drugs, biologics, devices, or medical foods) that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions.
Orphan Drug Designation carries multiple benefits, including the availability of grant money, certain tax credits and seven years of market exclusivity, as well as the possibility of an expedited regulatory process.
"IRBP once again thanks the FDA for recognizing REMUNE a novel therapeutic vaccine to treat all forms of HIV/AIDS including children with this debilitating disease. The REMUNE 808 pediatric study showed the vaccine was well tolerated and boosted immunity and a lower viral load P < 0.05. 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 in the future once we move into further pediatric studies" commented IRBP CEO Mr. Buswell.
"As we prepare for our BLA filing of REMUNE to bring the first HIV/AIDS vaccine to market and for approval for therapeutic HIV/AIDS vaccination this year i am pleased to see the government finally recognizing that REMUNE is the way to go, the whole killed vaccine approach is the tried and true method over the past 50 years to defeat a virus. REMUNE is a great and wonderful, safe, & effective vaccine that is probably the best the world is going to get. IRBP is grateful to the FDA and thanks the government for their support they did the right thing for children with HIV/AIDS. IRBP looks forward to working with the FDA to achieve a common goal of marketing approval for the first HIV/AIDS vaccine & partnering with big pharma to begin commercial manufacturing to help sick patients with this awful disease" 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