Business Wire - April 29, 2003
The Immune Response Corporation today announced the creation of a Scientific Advisory Board to counsel the company in the development and implementation of a clinical development plan for its HIV therapeutic vaccine REMUNE(R). The Board will be chaired by Gilbert S. Omenn, M.D., Ph.D., professor of Internal Medicine, Human Genetics and Public Health at the University of Michigan. The Immune Response Corporation also appointed Dorothy Bray, Ph.D., to serve as Clinical Development Advisor. She too will be directly involved in the plan's development and execution.
"Dedicated to the pursuit of sound science, the Scientific Advisory Board and Dr. Bray join The Immune Response Corporation in our mission to commercialize REMUNE(R)," said CEO John N. Bonfiglio, Ph.D. "Given their talent and expertise, I am confident in the many contributions these professionals will make as we endeavor to deliver the first therapeutic vaccine designed to treat people already infected with HIV."
The founding members of the Scientific Advisory Board include:
-- Chairman Gilbert S. Omenn, M.D., Ph.D., professor of Internal Medicine, Human Genetics and Public Health, University of Michigan;
-- Mario S. Clerici, M.D., professor and chair of Immunology, University of Milan;
-- Eduardo Fernandez-Cruz, M.D., professor and head of the Department of Immunology, University General Hospital Gregorio Maranon, Complutense University of Madrid, and principal investigator of the 2102 clinical trial of REMUNE(R), which was initiated in Spain in 1997; and
-- B.G. Gazzard, M.A., M.D., F.R.C.P., professor, Chelsea and Westminster Hospital in London.
(Full biographies of Board members may be found at the conclusion of this release.)
"The global HIV/AIDS epidemic continues to expand without adequate control of transmission or progression from infection to disease," noted Omenn. "The Scientific Advisory Board is committed to performing the necessary clinical studies to evaluate the prospects for a therapeutic vaccine to stimulate HIV-specific cellular immune responses that can help delay disease progression."
With the goal of launching a new clinical trial of REMUNE(R) by year-end, the company's management will consult with the Scientific Advisory Board, as well as other scientific experts, the U.S. Food and Drug Administration (FDA), European Medical Authorities and a network of HIV/AIDS activists to chart a roadmap for seeking regulatory approval to commercialize the vaccine. As Clinical Development Advisor, Bray, who has almost a decade of experience in HIV-specific clinical development with GlaxoSmithKline, also will be involved in this process.
"I am thrilled to have a role in driving the development of REMUNE(R) with the new leadership of The Immune Response Corporation," said Bray. "I believe there is an urgent need for immune-based therapies in the treatment of HIV."
About REMUNE(R)
Co-founded by medical pioneer Dr. Jonas Salk and headquartered in Carlsbad, Calif., The Immune Response Corporation is a biopharmaceutical company dedicated to treating HIV and AIDS through the development of REMUNE(R). REMUNE(R) is an immune-based therapeutic vaccine designed to induce an HIV-specific immune response and boost the body's natural defense mechanisms in order to slow the virus' progression. REMUNE(R) is comprised of HIV that has been chemically killed and inactivated so that it is non-infectious. During the inactivation process, the HIV outer envelope, which is prone to rapid mutations, is removed. REMUNE(R) is then emulsified in Incomplete Freund's Adjuvant, an agent that elicits a more potent immune response by drawing the immune system's attention to the inactivated virus.
HIV, the human immunodeficiency virus, is the virus that causes AIDS, a condition that slowly destroys the body's immune system, making it vulnerable to infections. More than 60 million people have been infected with HIV since it was first recognized in 1981. Today, 40 million people around the world are living with HIV.
This news release contains forward-looking statements. Actual results could vary materially from those expected due to a variety of risk factors, including whether the Company will continue as a going concern and successfully raise proceeds from financing activities sufficient to fund operations and additional clinical trials of REMUNE(R), the uncertainty of successful completion of any such clinical trials, whether REMUNE(R) will be effective as either a preventive or therapeutic vaccine, whether future trials will be conducted and whether the results of such trials will coincide with the results of REMUNE(R) in preclinical trials. These risks, among others, are set forth in The Immune Response Corporation's SEC filings including, but not limited to, its Annual Report on Form 10-K for the year ended December 31, 2002, and subsequent Quarterly Reports on Form 10-Q. The Company undertakes no obligation to publicly release the results 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.
THE IMMUNE RESPONSE CORPORATION SCIENTIFIC ADVISORY BOARD BIOGRAPHIES
-- Chairman Gilbert S. Omenn, M.D., Ph.D., Professor of Internal Medicine, Human Genetics and Public Health, University of Michigan
Omenn, a director of Amgen Inc. and of Rohm & Haas Company, served as Executive Vice President for Medical Affairs and as Chief Executive Officer of the University of Michigan Health System from 1997 to 2002. He was formerly Dean of the School of Public Health and Professor of Medicine and Environmental Health at the University of Washington, Seattle.
Omenn has authored 375 research papers and scientific reviews and has authored or edited 17 books. He is a member of the Institute of Medicine of the National Academy of Sciences, the American Academy of Arts and Sciences, the Association of American Physicians and the American College of Physicians. Omenn chaired the presidential/congressional Commission on Risk Assessment and Risk Management ("Omenn Commission") and the National Academy of Sciences/National Academy of Engineering/Institute of Medicine Committee on Science, Engineering and Public Policy.
Omenn received his B.A. from Princeton, M.D., magna cum laude, from Harvard Medical School and Ph.D. in genetics from the University of Washington.
-- Mario S. Clerici, M.D., Professor and Chair of Immunology, University of Milan, Italy
Prior to his work with the University of Milan, Clerici was a Visiting Scientist and Visiting Associate at the National Cancer Institute and the National Institutes of Health. He also was a Visiting Fellow at the Experimental Research Branch of the National Cancer Institute and National Institute of Health.
An expert in laboratory research and clinical immunology, Clerici has won numerous awards for his work, including: Best Abstract for the 12th and 13th International Conference on AIDS; ranking within the top ten of most cited scientists in HIV research by The Scientist and Science; "Europe's AIDS research star" by Science; International LIFE Prize for Basic Research on AIDS; and the Carlo Erba Foundation "Cecilia Cioffrese" Award for Viral Research.
He is a member of: the Finnish Society of Immunology; International AIDS Society; International Retroviral Association; American Association of Immunologists; and the Clinical Immunology Society; as well as of the scientific committees for French Government National AIDS Program, European HIV/AIDS centers of excellence within the European Community FP6 research plan, Fondazione Contarini, SHARE (educational program of the International AIDS Society), IRCCS Don Gnocchi Foundation, Clinical Immunology Society and Societa Italiana di Allergologia ed Immunologia Clinica.
Clerici has authored more than 250 publications in peer-reviewed scientific journals and seven invention reports selected by the NTIS, U.S. Department of Commerce, for both U.S. and foreign filings. He is a reviewer for: Nature; Nature Medicine; Science; Journal of Clinical Investigation; Journal of Virology; Immunology Today; Journal of Immunology; AIDS; Journal of AIDS; AIDS Research and Human Retroviruses, among others. Clerici also is a member of the editorial boards of The Journal of Immune Based Therapies, Clinical and Diagnostic Laboratory Immunology, Expert Opinion on Investigational Drugs and AIDS.
Clerici earned his M.D., magna cum laude, from the University of Milan.
-- Eduardo Fernandez-Cruz, M.D., Ph.D., Professor and Head of the Department of Immunology, University General Hospital Gregorio Maranon, Complutense University of Madrid, Department of Health, Community of Madrid, Spain
Prior to his work with the Department of Health of the Community of Madrid, Fernandez-Cruz was a Scientific Research Associate at the Scripps Clinic and Research Foundation in La Jolla, Calif., and Assistant Clinical Professor within the Department of Immunology and Allergy at the University of California, San Diego.
In addition to his expert scientific and clinical immunology work at the University General Hospital in Madrid, Fernandez-Cruz is Principal Investigator, National Coordinator and Member of the NIH Division of AIDS-sponsored International Steering Committee of the International Clinical Trial, ESPRIT, "International Study of Subcutaneous Recombinant IL-2 Proleukin in Patients with HIV Infection." He is Director of the European (Spanish) Clinical Trial with REMUNE(R), "A Multicenter, Double-blind, Placebo-controlled Randomized Study of HIV-1 Immunogen in HIV-infected Patients with Moderate Immune Suppression." He was formerly European Coordinator of the multinational clinical trial, ZIDON, "Zidovudine plus Interferon-alfa versus Zidovudine alone in HIV-infected symptomatic or asymptomatic persons," sponsored by Glaxo-Wellcome.
Among the awards and honors Fernandez-Cruz has received for his work are multiple selections for the First Award in Biomedical Research on AIDS. He also was awarded Permanent Residence Status by the U.S. Government for his research in the development of in vivo models of immunotherapy of tumors that may be applied to human therapy.
He is a member of: the European Federation Immunological Societies' European Clinical Immunology Group; the University General Hospital Gregorio Maranon's Committee for Ethics and Clinical Research; the Research Subcommittee of the National Plan for AIDS of the Ministry of Health; International Union Immunological Societies' International Committee of Clinical Immunology; Ministry of Health's National Advisory Committee of Medical Specialties in Immunology. Cruz is also a member of many honorary and professional organizations, including the British Society of Immunology, the Spanish Society of Immunology, the American Association of Immunology, the Spanish AIDS Society, the Society for Biological Therapy and the Clinical Immunology Society.
Fernandez-Cruz has authored more than 200 publications in peer-reviewed scientific journals -- with nine publications specific to REMUNE(R) -- and is an editorial board member and reviewer of national and international journals, including AIDS, Clinical Immunology and Immunopathology, Immunopharmacology and Immunotoxicology, Immunology and the Journal of the Interdisciplinary Spanish AIDS Society.
He received his M.D., cum laude, from the University of Madrid. He also holds Specialist Diplomas in Internal Medicine, Immunology and Clinical Immunology and Allergy.
-- B.G. Gazzard, M.A., M.D., F.R.C.P., Professor, Chelsea and Westminster Hospital, London, England
Since the beginning of the AIDS epidemic, Gazzard has been physician in charge of inpatient care for the HIV/GUM Unit of Chelsea and Westminster Hospital, the largest AIDS unit in England. He is a member of the MRC Clinical Trials Committee and a number of other international steering committees that coordinate antiretroviral studies across Europe, Australia and North America. He was principal investigator for the largest combination antiretroviral treatment trial.
He sits on the Steering Committee in charge of the bi-annual European AIDS meetings and is a member of the Scientific Committee of the World AIDS Congress, a council member of the European AIDS Association and a trustee of the British Medical Association AIDS Foundation.
Gazzard is published in more than 300 peer-reviewed publications on topics such as HIV, general medicine, infectious disease and gastroenterology. He has authored more than 30 chapters in books on the same subjects and has edited five books on gastroenterology and HIV disease. He is on the editorial boards of the International Journal of STD and AIDS and Drugs. He regularly reviews articles for publications such as AIDS, the Journal of Medical Ethics and the British Medical Journal.
Gazzard has earned numerous awards, including the Todd Prize in Medicine, the Legg Prize in surgery and the Ware Prize in Pathology. He received his M.D. from the University of Cambridge.
CONTACT: The Immune Response Corporation
Kathy Lane (investors), 760/771-2236; Fax: 760/771-2140
info@imnr.com
or
APCO Worldwide
Sara Jones (media), 213/893-7300; Cell: 818/326-1871
SOURCE: The Immune Response Corporation
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