PRLog (Press Release) - Aug 23, 2012 - IRBP believes REMUNE should have been approved long ago, the drug is very safe with over 25 trials conducted and shows good trends on reducing viral load, stable CD4+ T Cell counts and is a good option for HAART interruption. The REMUNE vaccine is also very important for drug naive patients, newly infected patients and those patients with multi drug resistance.
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.
POTENTIAL BENEFITS OF THIS TECHNOLOGY:
Administration of inactivated virus may stimulate humoral and cellular immune responses, which may slow the replication of HIV-1 through increased immunologic control over infected cells or other as yet undetermined mechanisms. The use of inactivated virus could theoretically stimulate broader immune responses that are capable of suppressing more diverse strains of HIV than vaccines based on sub-units of the virus. REMUNE for Treatment of Multi-Drug Resistance in patients with HIV. Transisitioning REMUNE to a Preventative Vaccine for those at risk of contacting the disease or in South Africa where a preventative vaccine treatment is necessary where the risk to reward ratio favors vaccination with a whole killed vaccine approach.
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. 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.
"There is absolutely no reason why patients should not have the option of the REMUNE vaccine and be denied the vaccine. Patients are probably better off being inoculated with REMUNE than not. Keeping REMUNE off the market and another treatment option for doctors and patients in their arsenal of weapons to combat the disease is bizarre. While REMUNE is not perfect it can be of help to the HIV/AIDS patient community. Those who do not want patients to have REMUNE should turn in their membership cards in the human race, you are charged with inhumanity to your fellow mankind." IRBP CEO Mr. Buswell
"Patients and doctors should be allowed to make their own informed decisions on whether REMUNE is right for them. My recommendation to the FDA should approve REMUNE as quickly as possible and give real relief to these patients. It is the humane, noble and honorable thing to do to help these sick patients. On the manufacturing front Omnia Biologics has a level three facility and suggests they can provide the Gamma Irradiation of REMUNE and we can use the previous vendors who assisted in past manufacturing of the vaccine to purify and chemically inactivate the virus." IRBP CEO Mr. Buswell
"We are still in the process of securing funding for manufacturing and filing fees with the FDA for REMUNE. The U.S.A. and the FDA should lead first in the world with the first approved HIV/AIDS vaccine and REMUNE with the whole killed method is the tried and true proven way to defeat a virus. IRBP believes once funding is secured that manufacturing can begin and the process to move the REMUNE vaccine to FDA approval with an emergency filing will be at hand. IRBP also believes first year sales of REMUNE can top over $5 billion dollars worldwide quite an incentive to invest in IRBP and help get REMUNE commercially manufactured to meet patient demand." IRBP CEO Mr. David Buswell