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

To: Walt who wrote (1431)	1/25/2000 7:58:00 AM
From: Walt	Respond to of 1510

News January 25, 2000 07:18 The Immune Response Corporation Announces the Start of a Trial To Examine the Effects of REMUNE During Early-Stage HIV-Infection CARLSBAD, Calif., Jan. 25 /PRNewswire/ -- The Immune Response Corporation (Nasdaq: IMNR) today announced that treatment of patients has begun in a trial designed to examine the effects of its investigational immune-based therapy REMUNE(TM) in combination with Highly Active Antiretroviral Therapy (HAART) when administered during the earliest stage of HIV infection. The 28-week study (REMUNE Study 905) is being funded by and conducted at Cedars-Sinai Medical Center in Los Angeles. The study will measure REMUNE's effect on HIV-specific immune responses and several markers of disease progression including CD4 cell count (the cells targeted for destruction by HIV) and viral load (the amount of HIV detected in the blood). "We are pleased to be the first to examine REMUNE in a population where HIV-specific immune responses have been shown by other investigators to control viral load," said Eric Daar, M.D., principal investigator of the study at Cedars-Sinai Medical Center, Los Angeles and Associate Professor at U.C.L.A. School of Medicine. "We hope to demonstrate that REMUNE can add some benefit to current therapies in the earliest stage of HIV infection." "When a person becomes infected with HIV, specialized cells of the immune system swing into action to combat viral growth," Dr. Daar explained. "Studies conducted by others have shown that strong cell-mediated immune responses against HIV during the earliest stage of infection (known as primary infection) are associated with control of viral load." "The emerging consensus among clinicians and scientists is that the course of disease progression may be favorably altered by gaining control of viral growth early during primary infection," said Dennis J. Carlo, President and Chief Executive Officer of The Immune Response Corporation. "Our studies have consistently suggested that REMUNE enhances cell-mediated immunity specifically against HIV. In the current trial, we have a chance to evaluate REMUNE's ability to enhance natural immune defenses against HIV early during the course of infection in combination with potent antiviral drug therapy and determine whether such an enhancement, if any, is associated with better control of viral growth." REMUNE Study 905 is a double-blind, adjuvant-controlled study to evaluate the effect of REMUNE compared to adjuvant, in combination with fully suppressive antiviral drug therapy, on HIV-specific immunity in patients with acute or primary HIV infection. Forty-five (45) HIV-infected people with acute or primary HIV infection will be enrolled. Thirty (30) patients will be treated with REMUNE injections and 15 patients will be treated with adjuvant (general immune stimulant). All patients will receive inoculations every 12 weeks for a total of three injections. All patients must be on an approved antiviral drug regimen and must have an initial viral load (plasma HIV RNA) less than 50 copies/mL. HIV-specific immunity will be assessed by skin test reactions to inoculation with HIV as well as by testing the ability of T lymphocytes (specialized immune cells) in a patient's blood sample to mount immune responses against whole HIV and HIV antigens. CD4 cell count, percent CD4, and viral load will also be measured as markers of disease progression. REMUNE is an HIV-specific investigational immune based therapy consisting of whole killed HIV-1 depleted of gp120 viral coat proteins. The inactivated material is emulsified with mineral oil (Incomplete Freund's Adjuvant) in the final formulation. The Immune Response Corporation is a biopharmaceutical company based in Carlsbad, California, developing immune-based therapies to induce specific T-cell responses for the treatment of HIV and autoimmune diseases. In addition, the Company is working on cancer vaccines and gene therapy. NOTE: News releases are available through PR Newswire Company News On-Call fax service. For a menu of available news releases or to retrieve a specific release made by The Immune Response Corporation, please call 800-758-5804, extension 434675. Please retain this number for future reference. Company information can also be located on the Internet Web Site: 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 this study, or any other studies, involving REMUNE will be successfully concluded. Those 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, 1998 and subsequent Forms 10-Q. 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(TM) is a trademark of The Immune Response Corporation. SOURCE Immune Response Corporation /CONTACT: Creighton W. Lawhead, Vice President, Head of Commercial Affairs and Investor Relations of Immune Response Corporation, 760-431-7080/ /Company News On-Call: prnewswire.com or fax, 800-758-5804, ext. 434675/ /Web site: imnr.com (IMNR) Walt