Results Indicate Approach Allowed for Extended Periods
Off Antiretroviral Therapy
CARLSBAD, Calif., Aug. 15 /PRNewswire-FirstCall/ -- Indicating for the
first time in a clinical trial that REMUNE(R) might give relief for HIV-
infected patients from the adverse side-effects of antiretroviral therapies,
The Immune Response Corporation (Nasdaq: IMNR) announced today results from an
ongoing study by the Canadian HIV Trials Network (CTN-140 trial), which
examined the effects of stopping HAART (Highly Active Antiretroviral Therapy)
in adults with chronic HIV infection.
"With the growing number of studies indicating that HIV-infected patients
are developing greater resistance and significant adverse side-effects to the
battery of antiretroviral drugs available today, the results from this study
suggest that treatment strategies using REMUNE(R) might give their systems the
break from drug therapies they need to recover," said Dr. Emil Toma, principal
investigator of the trial and a professor at University of Montreal and active
staff at Hotel-Dieu du Centre Hospitalier de l'Universite de Montreal (CHUM).
"With this study, we can further develop possible therapeutic approaches
designed to give patients a break from antiretrovirals while controlling viral
load and boosting the immune system."
The study, conducted over 116 weeks and still ongoing, involved ten adults
with a median age of 41 and ranging from 36 to 51 years of age. All had
chronic HIV infection and were on HAART for a median of 2.7 years, with HIV
RNA levels (VL) below detection limit (<50 HIV-1 RNA copies/ml) for a median
of two years and median CD4+ T cell count of 385/ml prior to antiretroviral
treatment interruption.
After HAART intensification with ddI, GM-CSF, hydroxyurea, and initiation
of therapeutic vaccination with REMUNE(R), patients stopped antiretrovirals,
but continued to receive REMUNE(R) every three months. To date, each
participant in the study has received nine doses of REMUNE(R).
"In chronically HIV-infected adults, HAART results in significant clinical
and immunologic benefits, but even prolonged suppression of HIV replication
does not prevent viral rebound when antiretrovirals are stopped," Dr. Toma
said. "We reasoned that intensification of an already optimal HAART (meaning
patients with HIV viral loads below detection limit) with ddI to better fight
the HIV in resting cells, hydroxyurea to diminish cell activation and to boost
the activity of ddI, GM-CSF to increase the activity of antiretrovirals in
reservoirs such as macrophages, and initiation of a therapeutic HIV vaccine
(REMUNE(R)) prior to stopping antiretrovirals, might lead to a partial
containment of viremia allowing for long periods without recourse to HAART."
Evaluations taken during the study included: clinical, virologic (viral
load, HIV genotype, sensitive cultures), immunologic (lymphocyte phenotyping,
serum cytokines/chemokines, Interferon-alpha (IFN-alpha) Elispot,
intracellular cytokine staining for IFN-alpha secretion from CD4+ and CD8+ T
cells, lymphoproliferative responses, thymus CT-Scans), health-related
quality-of-life, and nutrition.
"One patient has been off therapy for 88 weeks, having not resumed HAART
since first stopping and another was off therapy for 44 weeks after the second
interruption," Dr. Toma said. "The other participants stayed off HAART for an
average of 16 weeks after the first interruption and for an average of
24 weeks after the second interruption. It appears that at each subsequent
interruption there was a statistically significant decrease in the peak viral
load rebound and this was associated with an increased magnitude and breadth
of the HIV specific immune responses.
"Also, with each treatment interruption, the time to attain the peak viral
load increased and patients responded more quickly to HAART once it was re-
initiated, " Dr. Toma added. "These chronically infected patients behaved
like primary infection patients where partial control of virus is associated
with HIV specific immunity. For the 40 million people around the world
currently infected with this deadly disease, this study offers hope for
another possible treatment option using REMUNE(R)."
The data was presented at the recent 2002 Federation of American Societies
for Experimental Biology (FASEB) Meeting on Therapeutic and Preventive AIDS
Vaccines in Tuscon, Arizona.
Participating in the Canadian trial were Hotel-Dieu du CHUM, McGill
Research Centre, and Ste-Justine Hospital, all of Montreal, Quebec, and the
Canadian HIV Trials Network (CTN) in Vancouver, B.C.
Co-founded by medical pioneer, Dr. Jonas Salk and based in Carlsbad,
California, The Immune Response Corporation is a biopharmaceutical company
developing immune-based therapies designed to treat HIV, autoimmune diseases
and cancer. The Company also develops and holds patents on several
technologies that can be applied to genes in order to increase gene expression
or effectiveness, making it useful in a wide range of therapeutic applications
for a variety of disorders. Company information and a copy of the Canadian
trial abstract are also available at http://www.imnr.com .
This news release contains forward-looking statements. Actual results
could vary materially from those expected due to a variety of risk factors,
including, but not limited to, whether the Company will successfully raise
proceeds from financing activities sufficient to fund additional trials and
development of REMUNE(R), the uncertainty of successful completion of clinical
trials of REMUNE(R), whether REMUNE(R) is effective as either a preventive or
therapeutic vaccine, whether future trials will be conducted, and whether the
results of REMUNE(R) in clinical trials will coincide with the results of
REMUNE(R) in preclinical trials, and whether REMUNE(R) will be approved for
marketing or be successfully commercialized. These and other risk factors are
discussed more thoroughly in The Immune Response Corporation's SEC filings,
including but not limited to its Report on Form 10-K for the year ended
December 31, 2001 and Report on Form 10-Q for the quarter ended March 31,
2002. The Company undertakes no obligation to publicly release the result of
any revisions to these forward-looking statements, which may be made to
reflect events or circumstances after the date hereof or to reflect the
occurrence of unanticipated events.
REMUNE(R) is a registered trademark of The Immune Response Corporation.
SOURCE The Immune Response Corporation
 back to top
Related links:
http://www.imnr.com
CONTACT:
media, James Lee of The Lee Strategy Group,
+1-310-229-5771, or fax, +1-310-229-5772, jlee@leestrategy.com,
for The Immune Response Corporation; or investors, Kathy Lane of
The Immune Response Corporation, +1-760-771-2236, or fax,
+1-760-771-2140, info@imnr.com
|
