Encouraging Preliminary Clinical Results Reported for Immune-Based Therapy REMUNE
NEW YORK, July 2 /PRNewswire/ -- According to a preliminary report at the
12th World AIDS Conference in Geneva, patients treated with antiretroviral
combination therapy developed large immune responses to HIV as measured by
lymphocyte proliferation and beta-chemokine production and experienced more
frequent drops in plasma HIV below the level of detection when their drug
therapy was accompanied by REMUNE (the IRC HIV immunogen), an immune-based
therapeutic agent being developed by The Immune Response Corporation and
Agouron Pharmaceuticals, Inc.
Fred Valentine, M.D., Professor of Medicine, New York University Medical
Center reported preliminary results from a multi-center randomized, double-
blind, placebo controlled phase II study of 43 HIV-infected patients (median
viral load of 8159 copies/ml, median CD4+ T-cells of 493 cell/mm3) treated
with highly active antiretroviral drug therapy (HAART) consisting of
zidovudine (AZT) + lamivudine (3TC) + indinavir. After four weeks of HAART
treatment, these patients were randomized to receive the IRC HIV immunogen or
a placebo administered by intramuscular injection every three months. Sixteen
weeks after commencement of the study, 86% (18/21) of patients receiving both
the IRC HIV immunogen and HAART had viral loads (the amount of HIV in plasma)
below the limit of detection by an ultrasensitive assay (<40 copies/mL),
compared to 67% (12/18) of patients receiving HAART alone.
CD4+ T-cells were measured at week 20. Mean increases for the group
receiving the IRC HIV immunogen-containing regimen and the control group were
similar at 137 and 109 cells/mm3, respectively. The HAART + IRC HIV immunogen
treatment group experienced a statistically significant improvement in several
markers of immunologic response such as lymphocyte proliferation to HIV
antigens and responses to native p24, gpl20-depleted HIV, and whole BaL HIV.
No significant difference in more general immune responses to candida,
streptokinase or tetanus antigens was observed between groups. Additionally,
patients receiving HAART + the IRC HIV immunogen experienced significant
increases in production of MIP-1 beta (a beta-chemokine associated with viral
suppression) compared to the HAART + placebo group.
"This HIV-specific lymphocyte proliferative immune response in patients
receiving the IRC HIV immunogen + HAART," commented Dr. Valentine, "is
comparable to that seen in some individuals with nonprogressive disease."
This 32 week study was designed and initiated at the New York University
Medical Center in New York; the North Shore University Hospital in Manhasser,
New York, the Johns Hopkins University School of Medicine in Baltimore, the
Chicago Medical School, the Center for Blood Research in Boston, the
University of California at Irvine, the University of California at Davis, and
the Institute for Human Virology in Baltimore also participated.
New York University Medical Center is one of the nation's leading
biomedical resources, combining excellence in patient care, research and
medical education.
SOURCE New York University Medical Center
CONTACT: New York University Medical Center Office of Public
Affairs, 212-263-5488
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