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Biotech / Medical : IMNR - Immune Response -- Ignore unavailable to you. Want to Upgrade?

To: Bob Walsh who wrote (1412)	11/4/1999 8:17:00 AM
From: Bob Walsh	Read Replies (1) \| Respond to of 1510

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.