DATA SAFETY MONITORING BOARD RECOMMENDS COMPLETION OF A PHASE II REMUNE
TRIAL IN SPAIN OF PATIENTS INFECTED WITH HIV
CARLSBAD, Calif., Nov 4, 1999 /PRNewswire via COMTEX/ -- The Immune
Response Corporation (Nasdaq: IMNR) today announced that an independent
Data Safety Monitoring Board (DSMB) composed of European and U.S.
scientists recommended that the trial in Spain of Remune(TM) (trial
2102) in patients infected with HIV continue to its conclusion. This
decision followed review of efficacy data from the trial concerning
viral load (the amount of HIV detected in the blood) and CD4 helper
T-cell counts (immune cells selectively destroyed by HIV).
Professor Edwardo Fernandez-Cruz, Head of the Division of Clinical
Immunology at University General Hospital "Gregorio Maranon" in Madrid,
and Principal Investigator of the Spain trial commented, "We are
encouraged by evidence of the development of strong immune responses
specifically against HIV, including helper T-cell proliferation and
cytotoxic T-cell activity." T-cells are believed to play an important
role in controlling HIV infection, Professor Fernandez-Cruz explained,
because other researchers have noted an association of strong T-cell
immune responses in individuals who are infected with HIV but remain
AIDS-free for long periods of time (long-term nonprogressors). It has
become clear that treatment with antiretroviral drugs alone may not
prevent the rebound of HIV in some chronically infected patients, and
stimulation of the immune system specifically against HIV may be a key
to the long term control of HIV replication, Professor Fernandez-Cruz
added. Professor Fernandez-Cruz presented immunological data from the
trial (which will remain blinded until its conclusion) at The 4th
International Symposium of AIDS in Madrid, Spain, November 4-5, 1999.
"Given the DSMB's decision to continue the trial to completion, we are
hopeful that this trial will indicate that Remune has clinical
utility," said Dennis J. Carlo, Ph.D., President and CEO of The Immune
Response Corporation. "This trial is examining the effects of Remune
added to antiretroviral therapy on preventing treatment failure in
chronically infected individuals. The Company believes that while
antiviral drugs interrupt the reproduction process of HIV within
infected cells, Remune may stimulate the immune system to destroy
HIV-infected cells, an ability that is lost soon after infection with
HIV," added Dr. Carlo.
The Remune (2102) study in Spain is a double blind placebo-controlled
trial which enrolled 242 HIV infected patients not taking
antiretroviral drugs (ARTs) prior to time of enrollment. The efficacy
of Remune administered in combination with ARTs will be assessed by
comparing the time to increases in viral load (above 5000 copies/mL)
and decreases in CD4 helper T-cell counts between patient groups that
received ART plus Remune or ART plus placebo. Several immunological
markers of HIV disease progression, such as T-cell proliferation,
chemokine and cytokine production (antiviral messengers of the immune
system) and cytotoxic T-cells (T-cells that kill infected CD4 cells),
are also being monitored. The trial, being conducted at 13 clinical
centers throughout Spain, is expected to conclude in the latter part of
2000. |
