Immune Response BioPharma, Inc. Publishes Phase III Full 806 Study Results, REMUNE Very Effective Demonstrating 0.7% HIV Progression vs 6% Estimated Rate & Subgroup Median Virologic Failure Delayed by 20 Weeks In REMUNE Group.
Study 806 (Phase III Clinical Endpoint Study)
Study 8061 was a phase III double-blind clinical endpoint study with the primary endpoint as HIV disease progression, AIDS or death. This study involved two arms, REMUNE versus IFA, in the background of standard concomitant medications used for the treatment of HIV-infection. There were 2,526 patients enrolled. Patients were dosed every 12 weeks for up to 156 weeks. Study 806 was initiated in March 1996. Based upon a recommendation from the Data Safety Management Board (DSMB), Study 806 was terminated in May 1999. Summarized below are the primary activity and safety findings of Study 806.
Primary Endpoint Results
Study 806, a clinical endpoint trial in 2526 patients was concluded in May 1999 because no differences in clinical endpoints were seen and it was unlikely that a statistically significant difference would be seen if the trial continued. At the time of the DSMB meeting, there were 90 confirmed primary clinical endpoints. Subsequent to the termination of the trial an additional 16 primary clinical endpoints were confirmed. A total of 106 primary clinical endpoints occurred of which 53 occurred in the REMUNE -treated arm and 53 in the IFA-treated arm.
Summary of Study 806 Clinical Endpoints by Treatment Group
106 Primary (initial) Clinical Endpoints
(* Additional endpoints included; ** The majority of deaths were unrelated to HIV disease.)
Secondary Endpoint Results
HIV-1 RNA was evaluated in three populations:
Data on CD4 counts were obtained every 6 months. A statistically significant difference (by AUC analysis) in CD4 counts of 10.5 cells/μL favoring the REMUNE group (p = 0.05) was observed. No differences in CD4 % were seen between the groups.
Lymphocyte proliferation (LPA)
LPA measurements were conducted on the pre-selected random subset of subjects every six months. Statistically significant differences in response to HIV-1 and p24 antigens were observed for the REMUNE-treated subjects compared to the IFA subjects.10 Subjects who demonstrated the highest lymphocyte stimulation at Week 24 tended to be those with lower HIV-1 RNA at subsequent visits. This correlation was more consistent in the REMUNE group.
The conclusions of Study 806 (Clinical Endpoint Study) are:
a) No difference was seen in the primary endpoint of time to AIDS, HIV disease progression or death and there was no difference between groups in the number of primary clinical endpoints. HIV disease progression rates were much lower than the 6% projected: 1.4% based on the expanded list of clinical endpoints and 0.7% based on the original list of endpoints.
b) CD4 cell count increased in both groups over the course of the study.. No differences were seen between groups in CD4%.
c) No statistically significant difference was seen between groups in the primary virologic substudy analysis, however, the median time to virologic failure as defined in this analysis was 83.0 weeks in the IFA group and 102.9 weeks in the REMUNE group.
d) REMUNE-treated subjects demonstrated a significantly greater increase in lymphocyte proliferation to HIV-1 and np24 antigens compared to the IFA subjects at all follow-up visits tested. Subjects who demonstrated the highest lymphocyte stimulation at Week 24 tended to be those with lower HIV-1 RNA at subsequent visits. This correlation was more consistent in the REMUNE group.
e) REMUNE was well tolerated systemically. The most common adverse events related to study drug administration were injection reactions. There were more injection related adverse events that were rated as severe and very severe in the REMUNE group than in the IFA group but these injection reactions did not generally limit the continued administration of REMUNE. No serious, treatment-related adverse events were reported in the REMUNE group.
"REMUNE is perfectly good HIV/AIDS Vaccine and did its job in a difficult environment where the clinical study allowed patients in the trial who were taking different HIV/AIDS drugs with patients on any HAART drug. Among these patients who died they were goners to begin with, they had low CD4+ T Cell counts and their disease progression was advanced, REMUNE was not going to save them regardless of what drugs they were on or injections with the REMUNE vaccine. The majority of patients who died in the study were not the result of HIV and the REMUNE vaccine had no safety issues other than local site injection redness or pain showing the vaccine is very safe" Mr. Buswell CEO IRBP.
"In-fact REMUNE is a great drug and vaccine and can benefit the millions of patients infected with HIV/AIDS. It is very sad that one rogue researcher who was very irresponsible in his actions conned the DSMB into stopping the trial more than 3 years into it, and scaring people and patients that the vaccine did not work, in-fact it does work and the results which were suppressed i am publishing to get the truth out and full facts about the vaccines effectiveness to the public at large" Mr. Buswell CEO IRBP.
"REMUNE demonstrated a strong immune responses in the patients who received the vaccine and increased their CD4+TCell counts. The Data on CD4 counts were obtained every 6 months. A statistically significant difference (by AUC analysis) in CD4 counts of 10.5 cells/μL favoring the REMUNE group (p = 0.05) was observed. Also the REMUNE subgroup delayed virologic failure by 20 weeks and it delayed HIV progression strongly with .07% and 1.4% rates vs the estimated 6% disease progression rate REMUNE is a Great Vaccine for HIV/AIDS and is a viable treatment option, while it may not be an immediate cure it can help sick patients rebuild their immune systems and help them fight off this terrible disease. REMUNE is good enough right now for emergency FDA Approval and i will seek to get the vaccine approved with an emergency filing and seek commercial manufacturing help from a big pharma partner. Giving patients the choice and hope of the REMUNE vaccine is the right thing to do for them and a safe alternative to the toxic drugs, i will stop those who have conflicts of interest in keeping REMUNE out of patient hands" Mr. Buswell CEO IRBP.
Immune Response BioPharma, Inc. Maybe Found on the World Wide Web @ www.immuneresponse.net