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SMART ANTI-TAC ANTIBODY ENTERS INTERNATIONAL THIRD CLINICAL TRIAL

 MOUNTAIN VIEW, Calif., April 19 /PRNewswire/ -- Protein Design Labs (PDL)(NASDAQ: PDLI) today announced the start of a third clinical trial of the SMART(TM) Anti-Tac humanized antibody. Patient enrollment has begun for this multiple-dose study, which will be conducted in North America and Europe.
 SMART Anti-Tac is currently being investigated for the prevention of graft-versus-host-disease (GvHD). Future studies will include investigating SMART Anti-Tac for the prevention and treatment of organ transplant rejection and the treatment of certain autoimmune diseases and blood cancers. Hoffmann-La Roche Inc. (Roche) has exclusive worldwide rights to manufacture and market SMART Anti-Tac and is responsible for the clinical trials.
 "We are excited that Hoffmann-La Roche is giving SMART Anti-Tac a high priority," said Laurence Jay Korn, Ph.D., president and chief executive officer of Protein Design Labs. "At this time, we are not authorized by Roche to disclose further details about this clinical trial."
 In a Phase I single-dose study for steroid-resistant acute GvHD, SMART Anti-Tac did not produce appreciable side effects in any of 20 patients, did not elicit a human anti-mouse antibody (HAMA) response, and showed preliminary indications of activity.
 The goal of SMART Anti-Tac is to suppress the immune system by blocking the binding of Interleukin 2 to activated T cells. Only 5-10 percent of all T cells are activated by the presence of foreign cells to take part in the immune response that culminates in graft rejection and GvHD. Current immunosuppressive drugs suppress most or all T cells, leaving the body more susceptible to infection and certain malignancies.
 A second Phase I safety trial examining single doses of SMART Anti- Tac for treatment of certain blood cancers was conducted at the National Cancer Institute under the direction of Dr. Thomas Waldmann, chief of the Metabolism Branch.
 Separately, PDL said it has retained rights to commercialize the company's Recombinant Anti-Tac immunotoxin. In January 1993 Roche elected not to exercise an option it had been granted to acquire an exclusive license to this molecule, which genetically combines a bacterial toxin and the Anti-Tac antibody.
 Two PDL-designed SMART Antibodies are in clinical trials, SMART Anti-Tac and SMART M195, which is being investigated as a treatment for myeloid leukemia. In a presentation last month of preliminary Phase I data, principal investigator David A. Scheinberg, M.D., Ph.D., chief of the Leukemia Service at Memorial Sloan-Kettering Cancer Center, reported that SMART M195 is safe and well tolerated and has not caused an immune (HAMA) response in eight evaluated patients with relapsed acute myeloid leukemia who have received multiple infusions of the antibody.
 Results of early stage clinical trials may not be repeated in later stage trials. Evidence of efficacy and safety of an investigational drug must be demonstrated in larger, generally Phase III trials and still does not ensure regulatory approval.
 Protein Design Labs, founded in 1986, is engaged in the computer- based design and development of antibodies and other novel proteins to treat various disease conditions, including viral infections, autoimmune diseases and cancer. PDL has entered into corporate partnerships and product licensing agreements with four major pharmaceutical companies: Hoffmann-La Roche, Sandoz, Yamanouchi and Kanebo.
 PDL believes its SMART Antibodies will be less immunogenic than mouse monoclonal antibodies, and thus may be more effective as human therapeutics. PDL uses proprietary computer modeling techniques to combine the binding site of a mouse antibody with a large part of a human antibody. The resulting SMART Antibodies are more than 90 percent human, and they retain high binding affinity for the target antigens.
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 /CONTACT: Peter Dworkin, director, Corporate Communications, Protein Design Labs, 415-903-3721/
 (PDLI)


CO: Protein Design Labs ST: California IN: MTC SU:

TB-CK -- SJ004 -- 7657 04/19/93 17:59 EDT
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Date:Apr 19, 1993
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