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PROTEIN DESIGN LABS ANNOUNCES RESULTS OF CMV RETINITIS TRIAL IN AIDS PATIENTS

 MOUNTAIN VIEW, Calif., June 10 /PRNewswire/ -- Protein Design Labs Inc. (PDL)(NASDAQ: PDLI) today announced results of a Phase I/II clinical trial with its human anti-cytomegalovirus antibody for treatment of CMV retinitis in AIDS patients. The data are to be presented today at the IXth Infernational Conference on AIDS in Berlin.
 CMV retinitis is an infection of the eye that often results in blindness. About 20-25 percent of people with AIDS develop the disease, according to published studies.
 In this study, the anti-CMV antibody (MSL-109) was found to be safe and without noticeable side effects in 17 AIDS patients with CMV retinitis. No patients showed evidence of an immune response to the antibody. Patients were treated intravenously every two weeks for up to 16 weeks in combination with either ganciclovir or foscarnet, the approved drugs for CMV retinitis. The administered doses of antibody ranged from 0.25 to 5.0 milligrams per kilogram of body weight.
 The combination therapy appeared to delay retinitis progression approximately twice as long as have ganciclovir or foscarnet when administered alone in other studies. The median time to retinitis progression was 202 days compared to a median of 60 days in one large study and a range of 60-100 days in most previously reported studies of treatment with ganciclovir or foscarnet alone.
 The trial was conducted at the University of Texas Medical Branch, Galveston by Richard B. Pollard, M.D., and at the Massachusetts General Hospital/Harvard Medical School by Martin S. Hirsch, M.D.
 "The data suggest this CMV antibody was well tolerated, and there may be a prolongation of the time to progression of CMV retinitis in these patients compared to previously reported data for either ganciclovir or foscarnet as single agents," said investigator Pollard, who is presenting the data in Berlin today. "Based on these promising initial results and the apparent safety of the antibody, a Phase III trial is warranted."
 Laurence Jay Korn, Ph.D., president and chief executive officer of PDL, said PDL expects to begin a Phase II/III trial for CMV retinitis next year. "It is our hope that this compound will make a significant contribution to treatment of this major AIDS-related infection," Korn said.
 The results of the Phase I/II study are consistent with those of a preclinical study, in which the anti-CMV antibody was effective in a rabbit model of CMV retinitis when used alone and in combination with ganciclovir. However, results of early stage clinical trials may not be repeated in later stage trials, and 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.
 The anti-CMV antibody also has completed two Phase I trials for prevention of CMV infections in patients undergoing bone marrow transplants and a Phase I/II trial in patients with CMV viruria. These trials showed the antibody to be safe and well tolerated and to have a half-life of two-to-three weeks, potentially permitting dosing once or twice a month.
 Protein Design Labs, founded in 1986, is engaged in the development of next-generation antibodies and other novel proteins to treat various disease conditions, including viral infections, autoimmune and inflammatory diseases and cancer.
 The company has four potential products in clinical trials and two core proprietary antibody technologies. PDL uses computer modeling techniques to combine the binding site of a mouse antibody with a large part of a human antibody. The resulting SMART(TM) Antibodies, which are more than 90-percent human, retain high binding affinity for the target antigens and will, PDL believes, substantially reduce or avoid the human anti-mouse antibody (HAMA) response that has limited the use of mouse monoclonal antibodies as human therapeutics. Two SMART Antibodies are in clinical trials.
 PDL's second antibody technology is for development of human antibodies against viruses. This technology, as well as four human anti-viral antibodies developed with the technology, were acquired from Sandoz Pharmaceuticals Corp. and Sandoz Pharma Ltd. in April. Two of the human antibodies are in clinical trials. These are the anti-CMV antibody and an antibody against the hepatitis B virus.
 -0- 6/10/93
 /CONTACT: Peter Dworkin, director of corporate communications of Protein Design Labs, 415-903-3721/
 (PDLI)


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

SG-TM -- SJ001 -- 0444 06/10/93 08:15 EST
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Date:Jun 10, 1993
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