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PRLog (Press Release) - Jun. 8, 2013 - NEW YORK -- Immune Response BioPharma, Inc., Today Publishes Phase II IR103 REMUNEX Study Results IR103-111 or CTN 203 Demonstrated REMUNEX Provides Maximum Effect in Patients Treated with REMUNE + 1.0 Amplivax.
Dr. William Cameron
CTN 203 or IR103-111 PHASE II STUDY REMUNE + AMPLIVAX
A Phase I/II safety and immunogencity study of a combination of whole-killed HIV-1 antigen and Amplivax, administered with or without IFA, in HIV-1 infected Participants
This trial set out to determine the optimal dose and formulation of Remune, an experimental therapeutic HIV vaccine in individuals on HAART. The study compared four treatment groups to determine which combinations and doses were best able to generate high levels of efficient HIV-specific immune responses.
The study had four objectives:
1. The safety of immunization using IR103-Remune (HIV-1 antigen in IFA— a water and mineral oil mixture that helps to stimulate the immune system—and Amplivax administered intramuscularly (injected into the muscles).
2. The safety of immunization using IR104-Remune, a combination of Amplivax with HIV-1 antigen (without IFA) administered subcutaneously (into the skin).
3. To assess which dose of Amplivax plus Remune or HIV-1 antigen, in either formulation, is best capable of generating HIV-specific immune responses.
4. To measure changes in CD4 counts in the different treatment groups.
This was a Phase I/II (early stage), randomized, single-blind (either the researcher or the participant is unaware of the nature of the administered treatment), controlled, comparative study. The trial was conducted over 52 weeks at three clinical sites; one in Canada, and two in the UK.
A total of 180 participants were randomized into four treatment groups. Groups one and four had a combined total of 80 individuals who were receiving HAART-inclusive of NNTRI, a class of antiretroviral drug that inhibits the action of reverse transcriptase, and had an undetectable viral load. Groups two and three were each comprised of 50 individuals who had no more than seven days of antiretroviral treatment at any time prior to study entry (antiretroviral-naïve), with a viral load between 1,000 and 60,000 copies/ml.
All participants were eighteen-years of age and older, male or non-pregnant females and had a CD4 count of at least 300 cells/mm3.
The combination of Remune with Amplivax was well tolerated with no serious adverse events reported. Changes in the body’s immune system caused by the combination were dose dependent with the maximum effect seen in patients treated with Remune plus 1.0 of Amplivax.
The study results provide evidence of safety and tolerance and support further evaluation of this combination as a therapeutic HIV vaccine.
"These newly published results for the first time in a large enough study of IR103 REMUNEX vaccine (Remune + Amplivax) demonstrate success in the clinic with significant changes in immune responses favoring the IR103 group. We can build off these results for a new much larger Phase IIb & III studies. IRBP is pushing forward with approval of REMUNE in Thailand and Zimbabwe and then the rest of South Africa without delay in finding a partner for commercialization of the worlds first HIV/AIDS Vaccine. The Gilead's of the world are in for some serious competition there are no sacred cows in the HIV/AIDS space and the ice is melting beneath them. With billions of dollars at stake we are coming after their lunch, REMUNE will surprise many that is its better than anyone thinks" Mr. Buswell CEO IRBP.
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
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