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Protein Design Labs Reports Negative Results in Phase II Clinical Trial of Daclizumab in Ulcerative Colitis

Study Finds no Clinical Activity; Further Development to Focus on Asthma and Multiple Sclerosis

http://biz.yahoo.com/prnews/040516/sfsu001_1.html

May 16, 2004
Source: Protein Design Labs, Inc.
PRNewswire

Protein Design Labs, Inc. (Nasdaq: PDLI - News; PDL) today reported that its humanized antibody, daclizumab, did not meet the primary endpoint in a Phase II clinical trial in patients with moderate or severe ulcerative colitis. The primary efficacy endpoint in the study, the proportion of patients who achieved remission at week eight, did not meet statistical significance at either of the dose levels tested. Treatment with daclizumab antibody product was well tolerated.

Steven Benner, M.D., Senior Vice President and Chief Medical Officer, PDL, said, "We are disappointed that daclizumab did not demonstrate a clinical benefit in this setting. Based on these findings, we do not plan to further develop daclizumab as a treatment for ulcerative colitis.

"We remain firmly committed to the development of novel therapies in inflammatory bowel disease with the ongoing development of our Nuvion® antibody product for the potential treatment of patients with severe ulcerative colitis who failed to respond to treatment with intravenous steroids," Dr. Benner continued. "Based on recent encouraging Phase I results, as well as potential time to market, we continue to view Nuvion as our highest priority program.

"We are also committed to further development of daclizumab in additional indications, with top priority now in patients with chronic, persistent asthma," Dr. Benner added. "Our current plan is to follow the positive Phase II data in this setting reported earlier this year with a follow-on study. As the second priority for daclizumab, we also continue preparatory work for a PDL clinical trial in patients with multiple sclerosis. Our current plans are to initiate a follow-on study in each of asthma and multiple sclerosis by the first quarter of 2005."

Phase II Study Design

The randomized, double-blind, placebo-controlled Phase II clinical trial enrolled 159 patients at approximately 40 sites in North America and Europe. Patients were randomized to receive either daclizumab at 1 mg/kg at a four-week interval for a total of two doses, or 2 mg/kg every two weeks for a total of four doses, or placebo. The primary study objectives were safety and achievement of remission, defined by the Mayo score. Patients eligible for entry into the trial had evidence of active ulcerative colitis at baseline.

About Daclizumab

The FDA approved daclizumab for use in transplantation in December 1997, making it the first humanized antibody to gain marketing clearance in the United States. Daclizumab currently is marketed as Zenapax® by Roche for prevention of acute rejection in kidney transplantation. In September 2003, PDL and Roche announced that PDL had re-acquired from Roche the rights to market and manufacture daclizumab in indications other than transplantation, and an option to acquire rights in transplantation exercisable in 2006 and effective in 2007.

PDL Webcast, May 19

PDL will host a webcast beginning at 11:00 a.m. Eastern time on Wednesday, May 19, 2004, to discuss results and development strategies for its programs in inflammatory bowel disease, including more detail on the results of this Phase II daclizumab study. Dr. Benner will host the webcast. Scott Plevy, M.D., University of Pittsburgh; Gert Van Assche, University of Leuven, Belgium; and Daniel Hommes, M.D., Ph.D., affiliated with the Academic Medical Center, Amsterdam, The Netherlands, also will participate.

The live webcast will be available through the PDL website: http://www.pdl.com . Please connect to this website at least 15 minutes prior to the webcast to ensure adequate time for any software download that may be needed to hear and view the webcast. A replay will be available at http://www.pdl.com starting approximately one hour after completion of the webcast.

About Protein Design Labs

Protein Design Labs 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. Further information on PDL is available at www.pdl.com.

This press release contains forward-looking statements regarding our development programs and expectations. These statements involve risks and uncertainties, and PDL's actual results may differ materially from those in the forward-looking statements. Factors that may cause such differences include, in particular, changes in our plans based on future developments, as well as other factors which are discussed in PDL's Annual Report on Form 10-K for the year ended December 31, 2003, in its Quarterly Report on Form 10-Q for the three months ended March 31, 2004, and in other filings made with the Securities and Exchange Commission. In particular, there can be no assurance that PDL will initiate subsequent clinical trials of daclizumab in patients with asthma or multiple sclerosis, or that planned trials will be initiated in the timeframe currently anticipated.

NOTE: Protein Design Labs, Humanizing Science and Nuvion are registered U.S. trademarks and the PDL logo is a trademark of Protein Design Labs, Inc. Zenapax is a registered trademark of Roche.
 

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