NR - Recent Clinical Data Suggest That REMUNE(TM) May Help to Rebuild Immune
System When Used Alone or in Combination With Antiviral Drugs Against
AIDS Virus Thai Investigators to Propose REMUNE Monotherapy As First
Course of Treatment in HIV-Infected Individuals in Thailand
CARLSBAD, Calif., Mar 23, 2000 /PRNewswire via COMTEX/ -- The Immune Response
Corporation (Nasdaq: IMNR) announced today that recent clinical data suggest
that REMUNE(TM), its immune-based therapy to treat HIV infection, may induce HIV
immunity when used as a combination therapy with other antiviral drugs or when
used alone as a monotherapy. The data from multiple clinical trials were
presented at "An International Conference on HIV Vaccines -- An Annual Update --
2000" sponsored by the Thai Ministry of Public Health in Bangkok, Thailand.
Data were presented by Drs. Vernon Maino of Becton Dickinson, Fred Valentine of
New York University, Frances Gotch of Chelsea and Westminster Hospital in
London, Ron Moss of The Immune Response Corporation and Vina Churdboonchart and
Wisut Sukeepaisarncharoen of Thailand, all investigators of clinical trials that
examined the effects of REMUNE in HIV-infected patients. An observation common
to the multiple trials suggest that patients treated with REMUNE in combination
with antiviral drug therapy mount strong CD4 helper T cell immune responses
against HIV.
Data from the double-blind, placebo controlled study in Thailand, in which
REMUNE was examined as a monotherapy, were presented by Drs. Vina Churdboonchart
and Wisut Sukeepaisarncharoen. In this study, 297 HIV-1 infected patients who
had never taken antiviral drug therapy received either REMUNE or placebo during
the 40-week trial period and were monitored for several indicators of immune
health and disease progression. The primary measure of the number of CD4 helper
T cells was significantly higher (p<0.05) in the REMUNE treatment group.
Furthermore, delayed type hypersensitivity (DTH) skin tests and Western blots
(test that detects antibodies against HIV) performed on a random, pre-selected
subset of patients indicated that HIV-specific immunity was favored in patients
treated with REMUNE (p<0.05).
"While antiviral drug therapy has been very beneficial to HIV patients in
keeping viral load in check, it has not generally proven to help rebuild the
immune system, which is ravaged by the virus. A common theme among the trial
results reported today suggests that REMUNE may help to restore immune function
to these patients. In fact, it is the T helper cells -- the very immune cells
that are destroyed by the virus -- that appear to re-establish after treatment
with REMUNE," said Dr. Vina Churdboonchart, principal investigator for the trial
in Thailand. "This is important because an emerging consensus among HIV
researchers is that immune health may be the key to controlling HIV infection in
the long term." Dr. Churdboonchart stated that she is currently completing all
documentation necessary for submission to the Thai Minister of Public Health for
commercial approval of REMUNE in Thailand.
Dr. Sukeepaisarncharoen, a clinician in the Thai study, presented data obtained
during the follow-up period after the trial was completed on the same subset of
patients. He noted that 87% (59/68) of those patients tested 48 weeks after the
trial's end had stable (39 patients) or significantly decreased (20 patients)
amounts of HIV in the bloodstream, commonly referred to as viral load.
Furthermore, the decrease or stabilization of viral load was associated with a
sustained increase in number of CD4 helper T cells as well as increased body
weight.
"Several clinical parameters of immune health and disease progression assessed
in this trial and during the follow-up period suggest that REMUNE alone may be a
beneficial monotherapy in the treatment of HIV infection. This is particularly
important for HIV patients who do not have access to antiviral drug therapy,"
said Dr. Churdboonchart who indicated that based on these and previous results
submitted to the Thai Ministry of Public Health, the Thai investigators will
propose that REMUNE monotherapy be administered to HIV-infected individuals in
Thailand as a first course of treatment. |
