June 26, 2002
Protein Design Labs, Inc. (PDL) (Nasdaq: PDLI) today said that it has initiated a Phase I clinical trial to evaluate the safety and pharmacokinetics of its humanized SMART Anti-IL-12 Antibody. The trial is a randomized, blinded, dose-escalation trial to be conducted in up to 36 healthy adult volunteers in the United Kingdom. Participants will be randomized to receive a single dose of SMART Anti-IL-12 Antibody, or placebo, at one of four specified dose levels.
"IL-12 is a cytokine that may have considerable potential as a target in the therapy of autoimmune diseases," said Cary Queen, Ph.D., Senior Vice President, PDL. "Many autoimmune diseases are thought to be mediated by Th1 cells, a type of T cell that is generated in the presence of IL-12. Antibodies against IL-12 have been highly effective in reducing disease severity in animal models of multiple sclerosis, rheumatoid arthritis, psoriasis and inflammatory bowel disease."
SMART Anti-IL-12 Antibody was humanized at PDL from a murine anti-IL-12 antibody that was licensed, together with certain intellectual property related to anti-IL-12 therapy, from Hoffmann-La Roche Inc.
The foregoing contains forward-looking statements involving risks and uncertainties and PDL's actual results may differ materially from those in the forward-looking statements. Factors that may cause such differences are discussed in PDL's Quarterly Report on Form 10-Q for the quarter ended March 31, 2002, and in its Annual Report on Form 10-K, as amended, for the year ended December 31, 2001, and in other filings made with the Securities and Exchange Commission. In particular, there can be no assurance that PDL will complete the Phase I trial of SMART Anti-IL-12 Antibody, or that animal models will be predictive of results to be obtained in the Phase I trial or in the more extensive evaluations which would be required to show the antibody to be safe and effective.
Protein Design Labs, Inc. is a leader in the development of humanized antibodies to prevent or treat various disease conditions. PDL currently has antibodies under development for autoimmune and inflammatory conditions, asthma and cancer. PDL holds fundamental patents for its antibody humanization technology. For further information, visit http://www.pdl.com.
NOTE: Protein Design Labs and SMART are registered U.S.
trademarks and the PDL logo is a trademark of Protein Design Labs, Inc.
SOURCE Protein Design Labs, Inc.
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