More news came out over the weekend. Near the close on Friday, IMNX price started to run up. On Saturday they announce positive results on IL-4 treatment for asthma. The p values were modest, but that was due to a very small sample size (total of 17 patients). Of course LGND is targeting a small molecule that can be taken orally and made and modified cheaply.
Single Dose of Immunex's Nuvance (IL-4 Receptor)
Stabilizes Lung Function In Moderate Asthmatics
In Moderate Asthmatics
Pilot Study Findings Reported at AAAAI Meeting
SEATTLE, March 14 /PRNewswire/ -- Moderate asthmatics reported symptomatic
improvements for more than a week following a single 1500 mcg dose of Immunex
Corporation's investigational product Nuvance(TM) (Interleukin-4 receptor).
The findings of a pilot study were reported today at the American Academy of
Allergy, Asthma and Immunology Conference by Dr. Larry Borish of the National
Jewish Medical and Research Center.
Nine patients receiving the 1500 mcg dose had a statistically significant
increase (p=.05) in forced expiratory volume (FEV1) on day four as compared to
eight patients receiving placebo. These patients also experienced significant
improvement (p=.01) in forced expiratory flow (FEF25-75%). No significant
toxicity was experienced by patients in any group. Most reported adverse
events were of mild intensity, with the most frequent of these being mild
headaches and nasal congestion.
In addition, patients recorded their symptoms daily on a "report card."
Those patients receiving the 1500 mcg dose reported an 11 percent improvement
in asthma symptom scores during the first week -- decreases in wheezing,
shortness of breath, coughing, chest tightness, and nocturnal asthma.
Conversely, patients receiving placebo reported a 14 percent worsening in
asthma symptoms. The difference between the two groups being 25 percent. In
addition, patients receiving Nuvance didn't need to use their bronchodilators
(beta2-agonists) as frequently. The study also identified the
anti-inflammatory effects of Nuvance through decreases and stabilization of
levels of the inflammatory marker nitric oxide.
"Historically, we have relied on beta2-agonists to relax smooth muscle
tissue, in combination with corticosteroids to reduce inflammation," said Dr.
Borish, lead investigator in the clinical trial. "Nuvance represents an
approach that directly acts upon a likely biological cause of asthma,
Interleukin-4. Our knowledge of the biological properties of IL-4 suggests
that it is a major driver of the disease. Nuvance blocks IL-4 from binding to
its receptor molecule on the surface of both B and T cells and prevents a
series of biologic actions that lead to inflammation of the airways."
"Nuvance, the new brand name of our soluble IL-4 receptor, intercepts IL-4
molecules before they can start the cascade of allergic responses that lead to
lung inflammation and problematic breathing," said Peggy Phillips, senior vice
president of pharmaceutical development for Immunex. "These preliminary
results are encouraging and additional Phase I/II studies in asthma patients
are underway. We hope that Nuvance will be a potential therapy in asthma care
because it targets the cause of asthma symptoms."
The study involved 25 patients with moderate asthma (patients who
experience asthma symptoms daily and require daily use of both beta2-agonists
and inhaled corticosteroids). Patients were removed from inhaled
corticosteroid treatment and were divided into three groups receiving either
placebo or one of two doses of Nuvance (either 1500 mcg and 500 mcg). There
was no difference in efficacy between the placebo group and those patients
receiving the 500 mcg dose. The serum half life, or the time it takes for
half of the administered product to be cleared from the system -- a standard
measure of drug activity -- was found to be eight to eight and one-half days
in previous studies.
"While these preliminary findings demonstrate an impact on the signs and
symptoms of asthma, possibly the most exciting property of Nuvance is its long
half life," said Dr. Borish. "The biggest challenge of current therapies is
patient compliance with products that must be administered daily. Nuvance
represents the possibility of studying a weekly administration for patients."
About Asthma
Asthma is a chronic, inflammatory disorder. Nearly 15 million Americans
are asthmatics. Asthma in childhood is usually allergic (or atopic) -- a
result of a genetic predisposition to produce IgE antibodies in response to
allergens. In fact, asthma is the most common chronic disease of childhood --
affecting nearly 5 million children. It is estimated that nearly 50 percent
of asthma is triggered by a specific allergen. Triggers of non-allergic
asthma include exercise, cold air or irritants.
Irrespective of the trigger, the pathology of asthma involves
bronchoconstriction, mucus formation and chronic inflammation, the latter
characterized by eosinophil influx. Biologic drivers of asthma are complex.
However, research to-date has shown that the most common drivers involve IL-4:
IL-4 promotes the differentiation of naive T helper lymphocytes into Th2
lymphocytes and stimulates Th2 proliferation. Th2 lymphocytes are central to
chronic atopic inflammation. Eosinophil development and activation is driven
by cytokines produced by Th2 lymphocytes.
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 resulting in
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,
which create bronchoconstriction.
Inhibiting IL-4 may stop the cascade of cellular activity that expresses
itself as asthma symptoms.
Asthma impacts quality of life for its sufferers, causing 100 million days
of restricted activity annually. There are more than 450,000 asthma-related
hospitalizations each year and 5,000 deaths. Economically it is estimated to
cost $5.8 billion annually in both direct and indirect costs.
Immunex Corporation 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.
American Home Products 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 and over-the-counter medications. It is also
a leader in vaccines, biotechnology, agricultural products, and animal health
care.
This news release contains forward-looking statements that involve risks
and uncertainties, including risks associated with clinical development,
regulatory approvals, patent litigation, product commercialization, and other
risk described from time to time in the SEC reports filed by Immunex,
including the most recently filed Form 10-K and 10-Q.
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.
SOURCE Immunex Corp.
-0- 03/14/98
/CONTACT: media, Cathy Keck Anderson, 206-389-4039; or investors, Mark
Leahy, 206-389-4363/
/Web site: www.immunex.com/
(IMNX)
CO: Immunex Corp.
ST: Washington
IN: MTC
SU: PDT
KA-TW
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