Protein Design Labs Begins Phase II Study Of Humanized Anti-IL-4 Antibody In Asthma
FREMONT, Calif., Oct. 9 /PRNewswire/ -- Protein Design Labs, Inc. (PDL) (Nasdaq: PDLI - news) today announced the start of a Phase II clinical trial to evaluate its humanized antibody to interleukin-4 in asthma. Initiation of the trial triggered a milestone payment to PDL from GlaxoSmithKline (GSK) under the companies' collaborative development agreement. PDL licensed the humanized anti-IL-4 antibody from SmithKline Beecham, now GlaxoSmithKline, in 1999.
The randomized, double-blind, placebo-controlled study will be conducted in the United States in 120 symptomatic asthma patients who are not being treated with controller medications including inhaled steroids, leukotriene modifiers or long-acting beta agonists. Following a run-in period of two weeks' duration to confirm disease activity, patients will be randomized to one of two dosing regimens of humanized anti-IL-4 antibody or placebo. Patients will receive three, monthly intravenous infusions with a four-month follow-up period. The primary goals of the study are to determine safety, tolerability and preliminary efficacy.
Interleukin-4 is believed to be 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. GSK and 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.
``The rationale for studying this population is to determine whether our humanized anti-IL-4 antibody can be safely administered and demonstrate preliminary efficacy in a group of asthma patients with symptomatic disease when there are no confounding effects from other medications,'' said Daniel J. Levitt, M.D., Ph.D., President, Research and Development, PDL. ``Given the potential role of IL-4 in asthma, therapeutic strategies focusing on the inhibition or neutralization of IL-4 activity are important to explore. We believe that systemic delivery of our antibody will block IL-4 at all sites in the body where it could be active.''
Under the collaborative arrangement with GSK, PDL completed the Phase I clinical program and is conducting the Phase II trial; both phases were conducted in asthma patients. GSK is manufacturing the antibody for these clinical trials. PDL will be entitled to exclusive, worldwide development, marketing and sales rights to the humanized anti-IL-4 antibody unless GSK pays an opt-in fee at the end of Phase II clinical development. If GSK elects to participate, the two companies will share future development costs and profits at a previously agreed upon ratio. PDL may also receive certain co-promotion rights in the United States.
PDL previously reported Phase I clinical results with its humanized anti-IL-4 antibody in adult patients with mild-to-moderate asthma. In that trial, 24 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 18-21 days. PDL also conducted a Phase I/II study of humanized anti-IL-4 antibody in 14 patients with moderate-to-severe persistent asthma whose disease is poorly controlled. The primary objective was to evaluate the safety, tolerability and pharmacokinetics of humanized anti-IL-4 antibody in this patient population. While the study has been completed, treatment assignments have not yet been unblinded.
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, 2001, and its Annual Report on Form 10-K for the year ended December 31, 2000, and other filings made with the Securities and Exchange Commission. In particular, there can be no assurance the data from the Phase I clinical trial of the humanized anti-IL-4 antibody are indicative of results that may be obtained in the Phase I/II or Phase II trials or in the more extensive evaluation 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 United States, Europe and Japan for its antibody humanization technology. For further information, visit www.pdl.com. |
