Biotech Values

[DewDiligence]

PDLI’s asthma drug fails in ulcerative colitis:

[Program in asthma will continue.]

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

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

Sunday May 16, 12:00 pm ET

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

FREMONT, Calif., May 16 /PRNewswire-FirstCall/ -- Protein Design Labs, Inc. (Nasdaq: PDLI; 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."
<<