NR Clinical Data on REMUNE(TM) (Investigational HIV-1 Immunogen) Selected as a Late Breaker Presentation at the XIII International AIDS Conference in Durban, South Africa
Preliminary Results Suggest the Investigational Use of HIV Immune-Based
Therapy Alone or in Combination With Antiviral Drugs to Treat
HIV-Infected Individuals
CARLSBAD, Calif., July 14 /PRNewswire/ -- The Immune Response Corporation
(Nasdaq: IMNR) announced today that Trinity Medical Group, the Company's
licensee for development of REMUNE in Southeast Asia, has informed the Company
that follow-up data from the Phase II clinical trial conducted in Thailand
were presented at the XIII International AIDS Conference in Durban, South
Africa.
In a late-breaker oral presentation, Vina Churdboonchart, Ph.D., of
Mahidol University, Bangkok, Thailand, reported an update on preliminary
results from a follow-up study of HIV-infected people who were previously
enrolled in a 40-week Phase II trial of Remune in Thailand for which she was
the Principal Investigator. The main objective of the Phase II trial was to
determine the effect of Remune as a monotherapy on CD4 helper T cells, which
are the primary targets of HIV. Patients treated with Remune had
significantly higher CD4 counts (an average increase of 84 CD4 cells) compared
to the placebo group at the end of the 40-week placebo controlled trial.
Furthermore, the increase in CD4 cells was associated with increased immune
activity against the virus, as measured by delayed type hypersensitivity skin
tests (a measure of cell mediated immunity against HIV) and western blot (a
measure of antibodies against HIV).
Upon conclusion and unblinding of the Phase II trial, all patients were
allowed to participate in an on-going open-label extension study with
continued Remune treatments every 12 weeks without concomitant antiviral drug
therapy. Patients are being monitored for changes in immune responses,
including number of CD4 helper T cells (specialized white blood cells), in
addition to body weight (an indicator of general health) and viral load (the
amount of replicating HIV in the bloodstream).
A total of 27 HIV-infected patients participating in the open-label study
have completed an additional 96 weeks (total of 136 weeks) of receiving Remune
as a monotherapy. Results were reported as a comparison of measurements taken
at baseline (at the conclusion of the original 40-week trial) and at
136 weeks. For the entire group, on average, CD4 counts increased by
100 cells, body weight increased by 1.05 kilograms, and viral load remained
stable (4,800 copies HIV RNA per mL at baseline vs. 4,700 copies HIV RNA per
mL at 136 weeks).
"At the end of the 40-week trial, patients treated with Remune experienced
a significant increase in CD4 cells compared to the placebo group. In the
subset of patients reaching 136 weeks, we are seeing an even greater increase
in CD4 cells with specific activity against HIV, which suggests that improved
immune responses may be the result of prolonged treatment with Remune," said
Dr. Churdboonchart. "Equally notable is that even without antiviral drug
therapy, viral load has remained stable on average for nearly three years in
this subset of patients." Dr. Churdboonchart added that the patients selected
for the Phase II trial were asymptomatic and relatively healthy individuals,
such that the observed positive immune responses to treatment with Remune
underscore the importance of early intervention to management of HIV
infection.
"These data are particularly relevant for this year's AIDS meeting in
Africa as they suggest one potential strategy for slowing the AIDS epidemic in
developing countries where access to antivirals is limited," Dr.
Churdboonchart continued. "These results support our proposal to Thai health
authorities that Remune should be used as a first line therapy, with
cost-effective antivirals added on for non-responding patients. The stability
of these patients receiving REMUNE alone is comparable to that of clinical
non-progressors. These new data will be submitted to the Thai Ministry of
Public Health (the Thai FDA)." |
