PRLog (Press Release) - Dec. 17, 2012 - Immune Response BioPharma, Inc.™ Files for Orphan Designation of REMUNE™ for Pediatric HIV/AIDS. Immune Response BioPharma, Inc. Today announces plans to introduce REMUNE ™ therapeutic vaccine into the area of pediatric treatment options for patients suffering from Pediatric HIV/AIDS as a safe alternative HAART.
Pediatric HIV/AIDS is a disease afflicting children as HIV can be transmitted during sexual intercourse, pregnancy (i.e., from mother to fetus), childbirth, breastfeeding, and other forms of exposure to bodily fluids that carry the virus. When the virus enters the body, it injects itself into vital immune cells called CD4 cells. In the absence of treatment, HIV continues to replicate itself within the body, eventually leading to severe immunodeficiency, chronic illness, and death.
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.
Pediatric HIV/AIDS Surveillance Source CDC
Persons Living with Perinatally Acquired HIV Infection, Year-end 2009—46 States and 5 U.S. Dependent Areas N = 9,809
Perinatally Infected Persons Living with an AIDS Diagnosis, Year-end 2009—United States and 6 U.S. Dependent Areas N = 4,986
Perinatally Acquired HIV Infections in Children Born During 2010—46 States and 5 U.S. Dependent Areas N = 57
Time of Maternal HIV Testing among Infants with Perinatally Acquired HIV Infection, Birth Years 2007–2010—46 States N = 374
Diagnoses of HIV Infection and Population in Children Aged <13 Years, by Race/Ethnicity, 2010—46 States
Diagnoses of HIV Infection N = 217
“REMUNE is a wonderful treatment for HIV/AIDS and can benefit the pediatric population infected with this dreadful disease. IRBP will aim to bring REMUNE into the treatment arsenal for pediatric HIV/AIDS and give doctors the tools and ammunition they need to combat this life threatening disease. This is a great day for patients as IRBP moves closer to bringing REMUNE to commercialization. If i were big pharma i wouldn’t get to confident or comfortable that REMUNE will be kept of the market much longer or that we won’t secure funding. This is the beginning of the end of big pharma’s reign over the HIV/AIDS market” Mr. Buswell CEO IRBP.
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
