FREMONT, Calif., March 20 /PRNewswire/ -- Protein Design Labs, Inc. (PDL) (Nasdaq: PDLI - news) today announced the presentation of the first Phase I clinical results with its humanized anti-IL-4 antibody (SB240683) at the 57th Annual Meeting of the American Academy of Asthma, Allergy, and Immunology in New Orleans.
The study was designed to determine the safety and pharmacokinetics of the humanized anti-IL-4 antibody in adult patients with mild to moderate asthma. Twenty-four patients received a single intravenous dose at one of four dose levels (0.5, 1.5, 4.5, or 10 mg/kg) or placebo and were followed for 55 days. The humanized anti-IL-4 antibody was well tolerated with no serious or dose-limiting adverse events. The half-life of the antibody was approximately 18-21 days.
``Although not conducted in the primary target patient population for this antibody, this study does underline the safety, excellent pharmacokinetics and lack of immunogenicity of humanized anti-IL-4,'' said Daniel Levitt, M.D., Ph.D., President, Research and Development. ``We can now go forward and evaluate this drug in patients with more severe disease.''
Interleukin-4 (IL-4) is an important mediator of asthma and allergic diseases. Blockade of IL-4 could potentially inhibit the cellular pathways that lead to the production of other inflammatory cytokines and IgE antibodies, which are important in the development of asthma. PDL's humanized anti-IL-4 antibody is a high affinity, neutralizing antibody which has been demonstrated to competitively block binding of IL-4 to its receptor and to inhibit the synthesis of IgE antibodies in vitro.
PDL is conducting a Phase I/II multiple dose trial of the humanized anti-IL-4 antibody in patients with moderate to severe asthma and currently plans to initiate a Phase II trial in the same patient population later this year. PDL licensed the humanized anti-IL-4 antibody from SmithKline Beecham, now GlaxoSmithKline, in 1999. GlaxoSmithKline has the right to opt-in to the development program for this antibody at the conclusion of a specified Phase II trial. If they exercise this right, PDL and GlaxoSmithKline will share further development costs and potential profits... |
