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IDEC PHARMACEUTICALS TO BEGIN HUMAN CLINICAL STUDY OF MONOCLONAL ANTIBODY-BASED THERAPEUTIC FOR TREATMENT OF HIV INFECTION

 IDEC PHARMACEUTICALS TO BEGIN HUMAN CLINICAL STUDY OF MONOCLONAL ANTIBODY-BASED THERAPEUTIC FOR TREATMENT OF HIV INFECTION
 LA JOLLA and MOUNTAIN VIEW, Calif., Jan. 16 /PRNewswire/ -- IDEC Pharmaceuticals Corp. (NASDAQ: IDPH) announced today that it has received clearance to begin a Phase I human clinical study using an antibody-based therapeutic agent, known as 3C9, in patients infected with the human immunodeficiency virus (HIV). The study will be conducted at the University of California, San Diego Treatment Center. Recruitment of patients in the San Diego area will commence immediately and first treatments are expected to begin in February.
 "To our knowledge, this is the first monoclonal antibody-based therapeutic for HIV infection to enter human clinical testing," said William H. Rastetter, Ph.D., IDEC's president and chief executive officer. "3C9 is designed to stimulate the immune system to produce antibodies which neutralize the ability of HIV to infect the patient's disease-fighting CD4+ helper T-cells. The antibodies target the HIV binding site for CD4, which is present on all strains of the virus. It is our hope that this will help to overcome problems associated with the rapid mutation of the virus," Dr. Rastetter added. "Our intent is to provide an antibody therapy that acts much like a vaccine, stimulating production of broadly neutralizing antibodies and providing immune protection that could potentially delay or slow down the progress of HIV infection."
 IDEC Pharmaceuticals filed an Investigational New Drug (IND) Application with the Food and Drug Administration (FDA) in mid-December 1991. As in all Phase I clinical studies, the study which is about to begin is primarily a safety and tolerance study covering the use of 3C9 alone or in combination with the immunological adjuvant SAF. In addition, the immune response stimulated by 3C9 in the patients will be measured. The study will be conducted in HIV-infected, asymptomatic patients with CD4+ cell counts greater than 600. Treatment will consist of multiple intramuscular injections performed on an out-patient basis.
 "Although we believe that treatment with 3C9 may ultimately be complementary to antiviral therapies and possibly other therapeutic vaccines, it is important to emphasize that extensive clinical studies will be required before we will know whether 3C9 will be effective in the treatment of HIV infection," noted James A. Merritt, M.D., IDEC's director of clinical research.
 "We are extremely pleased, however, to have reached this important milestone in the development of this potential therapy," said Chang Y. Kang, Ph.D., an IDEC scientist whose pioneering work led to the discovery of 3C9.
 IDEC's goal has been the development of a therapeutic agent that will elicit high amounts of neutralizing antibodies in patients infected with HIV. 3C9 is designed to prompt the body to produce these high amounts of HIV-neutralizing antibodies by stimulating the patient's own immune response against the CD4 binding region of gp120, a response the virus itself does not elicit. Furthermore, the company is not aware of any other vaccines under development which have been able to elicit the broadly neutralizing antibodies against multiple strains of the virus observed with 3C9 in laboratory experiments. 3C9 has been developed by IDEC under a collaborative funding agreement with New York Life Insurance Company.
 IDEC Pharmaceuticals, which operates out of facilities in Mountain View and La Jolla, Calif., is a leader in the development of immunologically active monoclonal antibodies for therapeutic applications. With the commencement of the 3C9 study, the company will have five products in ongoing human clinical studies and other products in preclinical testing and research and development. These products are intended to address severe or life-threatening diseases, including immune system cancers (lymphomas and leukemias), melanoma and autoimmune disorders as well as HIV infection.
 -0- 1/16/92
 /CONTACT: Clifford Orent, Sr. V.P. and Chief Operating Officer, IDEC Pharmaceuticals, 415-940-1200/
 (IDPH) CO: IDEC Pharmaceuticals ST: California IN: MTC SU:


TS-SC -- NYON1 -- 0335 01/16/92 08:30 EST
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Date:Jan 16, 1992
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