Thursday March 22, 4:20 pm Eastern Time
Press Release
SOURCE: Immunex Corporation
Data from Two of Three Studies With
NUVANCE(TM) (soluble IL-4 receptor) Analyzed
No Apparent Relief for 'Uncontrolled' Asthma Patients, Awaiting Data
from Ongoing Study as Steroid Replacement
SEATTLE, March 22 /PRNewswire/ -- Immunex Corporation (Nasdaq: IMNX - news)
today announced results from part of its comprehensive Phase 2 program for NUVANCE.
In the two recently completed Phase 2 studies, NUVANCE was generally well- tolerated,
but provided no apparent improvement in opening lung airways over a four-week period for
patients with persistent asthma. A third Phase 2 study is continuing.
The third Phase 2 study will evaluate NUVANCE over a three-month period, in
approximately 200 asthma patients receiving steroid therapy. Results of the study are
expected in the third quarter of 2001.
``Because asthma is a highly variable disease, we established a panel of clinical studies as
part of our Phase 2 development program for NUVANCE, to assess its potential in a variety
of different study designs,'' said Leslie Garrison, MD, MPH, Immunex senior vice president
of clinical development. ``We observed no effect on lung function in asthma patients not using
long-term steroid therapy, but we await the results of the ongoing study in steroid- dependent
patients. We remain committed to the field of asthma with molecules in our pipeline, and
future development decisions for NUVANCE will be made when we have data from our
ongoing study.''
The two studies announced today were designed to assess the tolerability and efficacy of
NUVANCE in patients not using inhaled corticosteroids to see if NUVANCE would be
effective in opening lung airways (bronchodilation) and in keeping airways open over time.
The studies were double-blind, multi-center trials with a total of 246 patients. In the first
study, 142 patients were randomized to receive one of three doses of NUVANCE or
placebo by nebulizer once a week. In the second study, 104 patients were randomized to
receive one of two doses of NUVANCE or placebo by nebulizer once a day.
Preliminary analysis of the studies showed that NUVANCE was generally well-tolerated. Adverse events were similar in the
treatment groups. In the treatment group that received NUVANCE, there was no improvement in lung function as measured by
forced expiratory volume in one second (FEV(1)) when compared to placebo, which was the primary endpoint for the two
studies.
About Asthma
An estimated 17.3 million Americans suffer from asthma. During normal respiration, air enters through the nose and mouth,
passes through the trachea, and enters a system of complex bronchial tubes that end in tiny air sacs, known as alveoli. When
inflammation and muscle constriction cause these passages to narrow, and excess mucus production plugs up the narrowed
passages, asthma is the result. Of the approximately 17.3 million Americans with asthma, there are 8.8 million patients with
persistent disease, or those who experience chronic symptoms, over the age of five.
Immunex Corporation is a leading biopharmaceutical company dedicated to improving lives through immune system science
innovations.
NOTE: This news release contains forward-looking statements that involve risks and uncertainties, including risks associated
with clinical development, regulatory approvals, our reliance on third-party manufacturers, product commercialization and other
risks described from time to time in the SEC reports filed by Immunex, including the most recently filed Form 10-K. An
electronic version of this news release -- as well as additional information about Immunex of interest to investors, customers,
future employees and patients -- is available on the Immunex home page at www.immunex.com.
Immunex will host a conference call and live webcast at 2:30 pm PST today to discuss Immunex information disclosed today.
The live webcast can be accessed by going to the Immunex website at: immunex.com. Following
the webcast, an archived version of the call will be available at the same address until March 29, 2001.
SOURCE: Immunex Corporation |
