[ anti-CD25 for asthma/PDLI ]
Monday November 26, 4:00 pm Eastern Time
Press Release
SOURCE: Protein Design Labs, Inc.
Protein Design Labs Begins Phase II Trial of Zenapax
in Patients With Chronic Asthma
FREMONT, Calif., Nov. 26 /PRNewswire/ -- Protein Design Labs, Inc. (PDL) (Nasdaq:
PDLI - news) today announced that it has initiated a Phase II clinical study to evaluate its
humanized antibody daclizumab (Zenapax®) in patients who suffer from chronic, persistent
asthma and whose disease is not well controlled with high doses of inhaled corticosteroid
therapy.
The Phase II randomized, double-blind, placebo-controlled clinical trial will be conducted at
approximately 22 centers in the United States with a target enrollment of 120 patients. After a
run-in period to evaluate patient status while being managed on inhaled corticosteroids,
patients will be randomized to receive Zenapax or placebo. Zenapax will be administered at
two-week intervals, for a total of 10 doses. During the final eight weeks of the dosing
regimen, the use of inhaled steroids will gradually be reduced. Patients will be followed for a
period of 16 weeks at the end of treatment.
``The objective of this trial is to obtain safety and preliminary efficacy data for Zenapax in
patients with chronic, persistent asthma whose disease is not adequately controlled with
inhaled corticosteroid therapy,'' said Daniel J. Levitt, M.D., Ph.D., President, Research and
Development, PDL. ``Based on its strong safety profile as a marketed product and in
previous studies, we believe Zenapax may be appropriate as a long-term treatment for
asthmatic patients whose disease has proven difficult to control.''
Dr. Levitt pointed out that Zenapax is directed at the alpha chain of the human IL-2 receptor
(CD25). This receptor is found primarily on activated T lymphocytes. ``Because of the
observed correlation of increased CD25 expression on T lymphocytes in the lung and asthma
severity, CD25 is an appropriate target for asthma therapy,'' he added. ``By targeting
CD25-expressing cells with Zenapax to prevent the further activation of these cells, we may
inhibit the cascade of immune events that leads to airway inflammation and damage in
asthma.''
Asthma is the sixth most common chronic medical condition in the United States, affecting
more than 17 million people, according to the American Lung Association and the American
Academy of Allergy, Asthma and Immunology (AAAAI). The disease is responsible for an
estimated 5,300 deaths annually and an estimated $12.6 billion in direct and indirect health care costs, according to AAAAI.
Zenapax is the second humanized antibody in PDL's product pipeline to advance to Phase II clinical testing in asthma patients.
In September 2001, PDL initiated a Phase II study of a humanized anti-IL-4 antibody in symptomatic adult asthmatics who are
not being treated with asthma controller medications.
Zenapax also is being tested as maintenance therapy to prolong remission of psoriasis. PDL has completed accrual of patients
in a Phase II trial in which patients with moderate-to-severe psoriasis are initially treated with cyclosporine. A total 126 patients
who responded to cyclosporine were randomized to receive Zenapax in one of two dosing regimens or placebo, and are being
followed for time to disease recurrence. PDL currently expects to report data from that Phase II clinical trial in March 2002.
The FDA approved Zenapax in December 1997, making it the first humanized antibody to gain marketing clearance in the
United States. Zenapax currently is marketed by PDL partner Hoffmann-La Roche Inc. for prevention of rejection in acute
kidney transplantation. It is being tested in additional disease indications including type I diabetes, multiple sclerosis, ulcerative
colitis and uveitis.
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 September 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, we
may be unable to complete the described trials or to report data at the planned times.
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.
NOTE: Protein Design Labs and the PDL logo are registered U.S. trademarks of Protein Design Labs, Inc. Zenapax is a
registered U.S. trademark of Hoffmann-La Roche Inc.
SOURCE: Protein Design Labs, Inc. |
