FREMONT, Calif., Oct 30 /PRNewswire/ -- Protein Design Labs, Inc. (PDL, the "Company") (Nasdaq: PDLI) today announced the presentation of Phase I clinical results with its investigational drug SMART(TM) Anti-Gamma Interferon Antibody at the 64th Annual Meeting of the American College of Rheumatology in Philadelphia. The Company also announced plans to initiate a Phase I/II clinical trial of this antibody in Crohn's disease, an autoimmune inflammatory bowel disease.
In the Phase I dose-escalation trial, 22 healthy volunteers received single intravenous doses ranging from 0.01 mg/kg to 4.0 mg/kg of SMART Anti-Gamma Interferon to evaluate safety, pharmacokinetics, and pharmacodynamics. The antibody was safely administered to the subjects, with no serious or severe adverse events reported at the doses tested. The half-life of the antibody was approximately 2-3 weeks, and there was no pharmacokinetic evidence of antibodies to SMART Anti-Gamma Interferon.
In addition, as a measure of the activity of the antibody, the ability of SMART Anti-Gamma Interferon to block a delayed-type hypersensitivity (DTH) reaction was determined. DTH is an inflammatory immune response to test antigens administered into the skin, and is known to be mediated in part by gamma interferon. A familiar example of the DTH reaction is the common medical skin test for tuberculosis. In the subjects receiving a dose of the SMART Anti-Gamma Interferon Antibody of 0.03 mg/kg or more, the DTH reaction was reduced by at least 60% compared to that observed in a pre-treatment antigen challenge in 22 of 29 evaluable skin tests (mumps and Candida albicans), and was reduced by at least 90% in about half of the 29 tests.
"These encouraging Phase I results suggest that SMART Anti-Gamma Interferon can be safely administered in a range of doses," said Daniel J. Levitt, M.D., Ph.D., President, Research and Development. "Further, the DTH data suggest the antibody is active at low doses and could play a role in the treatment of autoimmune conditions in which gamma interferon may be important, such as inflammatory bowel disease, diabetes mellitus, multiple sclerosis and rheumatoid arthritis. As a result, we currently plan to initiate a Phase I/II trial in patients with Crohn's disease by year-end."
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 the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2000, and its Annual Report on Form 10-K for the year ended December 31, 1999. In particular, there can be no assurance the data from this clinical trial of the SMART Anti-Gamma Interferon Antibody are indicative of results that may be obtained in the more extensive clinical trials 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 in the U.S., Europe and Japan for its antibody humanization technology.
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