181 Patient Study Shows Improved Lung Function as Measured by Daily FEV1, Dose
Response, and That NUVANCE Was Generally Well Tolerated
SEATTLE, May 25 /PRNewswire/ -- The product development program for
NUVANCE(TM) (soluble IL-4 receptor) is progressing based on the results of the
first phase II clinical trial of NUVANCE in patients with asthma,
Immunex Corp. (Nasdaq: IMNX) announced today. NUVANCE is the first product of
its kind to be evaluated in clinical trials.
"We are encouraged by our preliminary analysis showing that IL-4
modulation is a well-tolerated and promising investigational approach to
controlling the asthma disease process," said Ann Hayes, MD, senior vice
president, medical development. "Now, we are advancing the development
program for NUVANCE according to our already established timeline to optimize
inhibition of IL-4 with NUVANCE."
This phase II trial is the first to assess the ability of NUVANCE to
control asthma in patients who were not receiving inhaled steroids. The study
was a multi-center, double-blind, placebo-controlled trial with 181 patients.
Patients were randomized to receive one of two doses of NUVANCE or placebo by
inhalation once a week.
The preliminary analysis conducted by Immunex of the phase II trial showed
that asthma patients treated with NUVANCE experienced improvement in lung
function as measured by daily forced expiratory volume in one second (FEV1)
when compared to placebo. Patients with more severe asthma treated with
NUVANCE experienced significant improvement in daily FEV1 when compared to
placebo. In addition, patients with a marked response to NUVANCE as measured
by improved daily FEV1, also experienced significant improvement in peak flow
and asthma symptom scores. A dose response was demonstrated, with the high
dose of NUVANCE outperforming the low dose.
In the study, FEV1 was also measured on a weekly basis in the clinic just
prior to the patients taking their next dose of study drug or placebo.
Patients measured weekly in the clinic experienced improvement in FEV1, but
there was not a significant difference among the treatment groups.
NUVANCE was generally well tolerated. The most common adverse events
reported in this study were upper respiratory infection-URI (44% in patients
treated with NUVANCE compared to 47% in patients treated with placebo) and
headache (19% in patients treated with NUVANCE compared to 17% in patients
treated with placebo).
FEV1 is a measure of lung function. To measure FEV1, a patient exhales
into a device. In asthma, airway constriction, inflammation and airway
obstruction reduce the amount of air that can be exhaled quickly. As asthma
symptoms worsen, FEV1 decreases, reflecting the reduced lung function
experienced by asthmatics.
This phase II study in patients with under-treated asthma was conducted
after the positive results of an earlier phase I/II in patients receiving
inhaled steroids. In the phase I/II study, patients stopped use of inhaled
steroids, and then began treatment with NUVANCE.
IL-4 promotes the differentiation of naive T helper lymphocytes into Th2
lymphocytes. Th2 lymphocytes secrete cytokines such as IL-4, IL-5, IL-9 and
IL-13, which are key mediators of asthmatic inflammation. IL-4 is one of the
molecules that induce mucus production by lung mucus glands, contributing to
airway obstruction. IL-4 regulates expression of the adhesion molecule
VCAM-1, which interacts with the VLA4 molecule on the surface of eosinophils.
This interaction allows eosinophils to migrate from the blood and into the
lung tissue to sites of inflammation. IL-4 induces B cell proliferation and
the production of antigen-specific IgE that is required to trigger allergic
response. Antigen-specific IgE causes mast cells to release inflammatory
"mediators," such as histamines and leukotrienes, and these create
bronchoconstriction.
Immunex is a biopharmaceutical company dedicated to developing immune
system science to protect human health. The company's products offer hope to
patients with cancer, inflammatory and infectious diseases.
AHP owns a majority interest in Immunex. AHP is one of the world's
largest research-based pharmaceutical and health care products companies. It
is a leader in the discovery, development, manufacturing and marketing of
prescription drugs, including biotechnological and vaccine products, animal
health care products and over-the-counter medications.
NOTE: This news release contains forward-looking statements that involve
risks and uncertainties, including risks associated with clinical development,
regulatory approvals, product commercialization and other risks described from
time to time in the SEC reports filed by Immunex, including the most recently
filed Form 10-Q and 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 http://www.immunex.com.
SOURCE Immunex Corporation
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http://www.immunex.com
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CONTACT:
media, Tim Warner, 206-470-4193, or investor,
Mark Leahy, 206-389-4363, both of Immunex
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