The Immune Response Corporation Appoints Scientific Advisors to Strengthen Clinical Development of REMUNE.Business Editors/Health/Medical Writers BIOWIRE2K CARLSBAD, Calif.--(BUSINESS WIRE)--April 29, 2003 Company Taps University of Michigan's Gilbert S. Omenn, M.D., Ph.D., to Chair New Scientific Advisory Board, and Dorothy Bray, Ph.D., to Serve as Clinical Development Advisor The Immune Response immune response n. An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes. Corporation (Nasdaq:IMNR) 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 HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. therapeutic vaccine therapeutic vaccine Immunology A vaccine–eg, Salk's Remune™ intended to treat a viral infection by stimulating the immune system. See Vaccine therapy. REMUNE(R). The Board will be chaired by Gilbert S. Omenn, M.D., Ph.D., professor of Internal Medicine, Human Genetics Human genetics A discipline concerned with genetically determined resemblances and differences among human beings. Technological advances in the visualization of human chromosomes have shown that abnormalities of chromosome number or structure are surprisingly and Public Health at the University of Michigan (body, education) University of Michigan - A large cosmopolitan university in the Midwest USA. Over 50000 students are enrolled at the University of Michigan's three campuses. The students come from 50 states and over 100 foreign countries. . 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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 in·fect tr.v. in·fect·ed, in·fect·ing, in·fects 1. To contaminate with a pathogenic microorganism or agent. 2. To communicate a pathogen or disease to. 3. To invade and produce infection in. 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 immunology, branch of medicine that studies the response of organisms to foreign substances, e.g., viruses, bacteria, and bacterial toxins (see immunity). Immunologists study the tissues and organs of the immune system (bone marrow, spleen, tonsils, thymus, lymphatic , University of Milan The university is a member of the League of European Research Universities. Throughout Milan, the University is normally known as Statale to avoid confusion with other academic institutions in the city. ; -- Eduardo Fernandez-Cruz, M.D., professor and head of the Department of Immunology, University General Hospital Gregorio Maranon, Complutense University of Madrid The Complutense University of Madrid (Spanish: Universidad Complutense de Madrid, UCM) is one of the oldest universities in the world and the top public university in Spain. , 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 Westminster Hospital moved from Marsham Street to become Chelsea and Westminster Hospital at the old St Stephen's Hospital site in 1994. in London. (Full biographies of Board members may be found at the conclusion of this release.) "The global HIV/AIDS HIV/AIDS Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome epidemic epidemic, outbreak of disease that affects a much greater number of people than is usual for the locality or that spreads to regions where it is ordinarily not present. 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 cellular immune response n. See cell-mediated immune response. 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ), European Medical Authorities and a network of HIV/AIDS activists to chart a roadmap for seeking regulatory approval to commercialize the vaccine vaccine Preparation containing either killed or weakened live microorganisms or their toxins, introduced by mouth, by injection, or by nasal spray to stimulate production of antibodies against an infectious agent. . 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 thrill v. thrilled, thrill·ing, thrills v.tr. 1. To cause to feel a sudden intense sensation; excite greatly. 2. To give great pleasure to; delight. See Synonyms at enrapture. 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 Noun 1. Jonas Salk - United States virologist who developed the Salk vaccine that is injected against poliomyelitis (born 1914) Jonas Edward Salk, 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 in·duce v. 1. To bring about or stimulate the occurrence of something, such as labor. 2. To initiate or increase the production of an enzyme or other protein at the level of genetic transcription. 3. 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 inactivated rendered inactive; the activity is destroyed. inactivated viruses treated so that they are no longer able to produce evidence of growth or damaging effect on tissue. so that it is non-infectious. During the inactivation inactivation /in·ac·ti·va·tion/ (in-ak?ti-va´shun) the destruction of biological activity, as of a virus, by the action of heat or other agent. process, the HIV outer envelope, which is prone to rapid mutations, is removed. REMUNE(R) is then emulsified in Incomplete Freund's Adjuvant Freund's adjuvant n. A substance consisting of killed microorganisms, such as mycobacteria, in an oil and water emulsion that is administered to induce and enhance the formation of antibodies. , 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 human immunodeficiency virus n. HIV. Human immunodeficiency virus (HIV) A transmissible retrovirus that causes AIDS in humans. , is the virus that causes AIDS, a condition that slowly destroys the body's immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. , 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 forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. . 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 preventive /pre·ven·tive/ (pre-vent´iv) prophylactic. pre·ven·tive or pre·ven·ta·tive adj. Preventing or slowing the course of an illness or disease; prophylactic. n. 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 Noun 1. preclinical trial - a laboratory test of a new drug or a new invasive medical device on animal subjects; conducted to gather evidence justifying a clinical trial preclinical phase, preclinical test . 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2002, and subsequent Quarterly Reports on Form 10-Q Form 10-Q See 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 CIRCUMSTANCES, evidence. The particulars which accompany a fact. 2. The facts proved are either possible or impossible, ordinary and probable, or extraordinary and improbable, recent or ancient; they may have happened near us, or afar off; they are public or after the date hereof here·of adv. Of this. hereof Adverb Formal or law of or concerning this Adv. 1. hereof - of or concerning this; "the twigs hereof are physic" 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.
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