Protein Design Labs Announces Results of Phase II Clinical Trial
Of Zenapax(R) in Psoriasis
- Mar 20, 2002 04:00 PM (PR Newswire)
- finance.lycos.com
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/FROM PR NEWSWIRE SAN FRANCISCO 415-543-7800/
[STK] PDLI
[IN] BIO MTC
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TO BUSINESS AND MEDICAL EDITORS:
Protein Design Labs Announces Results of Phase II Clinical Trial
Of Zenapax(R) in Psoriasis
FREMONT, Calif., March 20 /PRNewswire-FirstCall/ --
Protein Design Labs, Inc. (NASDAQ:PDLI) (PDL) today announced preliminary
results from a Phase II clinical trial of the humanized antibody Zenapax
(daclizumab) as maintenance therapy for patients with moderate-to-severe
psoriasis following treatment with cyclosporine. The results indicated that
while daclizumab was well-tolerated, the antibody, at the dose levels
administered, did not prolong the time to recurrence of psoriasis, the primary
endpoint of the trial.
"The data indicate that daclizumab did not prolong remissions of psoriasis
obtained with cyclosporine in either of the dose regimens tested in this
trial," said Daniel J. Levitt, M.D., Ph.D., President, Research and
Development, PDL. "There was a statistically significant prolongation of
remission in the subgroup of patients with moderate psoriasis treated with
daclizumab every other week for five doses compared with the placebo control.
However, this same regimen was statistically significantly less effective than
the placebo arm in patients with more severe psoriasis. In both experimental
arms, psoriasis recurred in a substantial proportion of patients while they
were still receiving daclizumab."
Laurence Jay Korn, Ph.D., Chief Executive Officer and Chairperson, PDL,
said, "Based upon our initial analysis of the preliminary Phase II data, PDL
does not plan to pursue additional development of daclizumab as a maintenance
agent in psoriasis following treatment with other therapeutic agents. As we
evaluate the data further, we will decide whether or not to pursue other
development options for daclizumab in psoriasis. We do plan to continue to
explore the use of daclizumab in other indications, and currently there are
trials underway in asthma, multiple sclerosis, type I diabetes and uveitis."
The Phase II, randomized, double-blind, placebo controlled clinical trial
of daclizumab in psoriasis was conducted at 12 centers in the United States
and Canada. Patients with moderate-to-severe psoriasis were initially treated
with cyclosporine for a period of one to three months. In this trial, 76% of
patients achieved remission with cyclosporine, defined as a 75% reduction in
Psoriasis Area and Severity Index (PASI) score. Patients who responded to
cyclosporine were then randomized to receive daclizumab in one of two dosing
regimens, or placebo. In each of the daclizumab treatment arms, patients
received a total of five doses at 1 mg/kg. In one daclizumab treatment
regimen, patients received one dose every 14 days for a total of five doses.
In the second daclizumab treatment regimen, the first two doses were 14 days
apart, with the remaining three at monthly intervals. The primary endpoint of
the trial was the length of time to recurrence of psoriasis, indicated by a
return to 50% of the patient's baseline PASI score. A total of 127 patients
were randomized in the trial. The median baseline PASI score of patients was
14.1 and the median body surface area affected was 20%.
Daclizumab is directed at the alpha chain of the human IL-2 receptor
(CD25), and was approved by the FDA in December 1997 for the prevention of
rejection in kidney transplantation. Zenapax is marketed worldwide by PDL
partner Hoffmann-La Roche and affiliates (Roche) in kidney transplantation.
In 1999, PDL reacquired from Roche the rights to develop daclizumab in
autoimmune diseases. |
