GAITHERSBURG, Md., Dec. 4 /PRNewswire/ -- MedImmune today announced that
it has initiated a Phase 2 clinical trial in patients with chronic asthma to
determine the safety of subcutaneous dosing of a humanized monoclonal antibody
(MAb) that targets the interleukin-5 receptor (IL-5R). Preclinical data
suggest that inhibiting the IL-5R pathway may lead to a targeted approach for
treating patients with asthma, supporting continued study of this antibody.
"Asthma can be a very debilitating disease, and despite current therapies,
patients are in need of novel treatment options," said Nestor Molfino, M.D.,
vice president, clinical development, pulmonary disease. "Some asthmatics may
show an increased circulation of eosinophils in blood -- a certain type of
white blood cell believed to play a critical role in the severity and disease
pathway of asthma; therefore administration of this antibody may increase
asthma control."
MEDI-563, which was generated using BioWa's POTELLIGENT(TM) Technology
platform, has previously been investigated in a Phase 1 open-label
dose-escalating study to evaluate the safety and tolerability of a single
intravenous infusion in adults with mild-to-moderate asthma. Data from the
completed Phase 1 study demonstrated that the antibody was well-tolerated with
biologic activity producing substantial and prolonged depletion of blood
eosinophils, thus supporting its continued development. Published literature
suggests that reduction of eosinophils in sputum was associated with better
asthma control and increases in sputum eosinophilia were associated with
exacerbations of asthma. The antibody is also currently being evaluated in a
double-blind, placebo-controlled Phase 1 study to evaluate the safety and
tolerability and effects of the antibody on airway eosinophils in adults with
asthma.
About Interleukin-5 Receptor (IL-5R)
Interleukin-5 is a cytokine secreted predominantly by T-lymphocytes, mast
cells, and eosinophils involved in regulating the differentiation,
proliferation, and activation of eosinophils via the IL-5 receptor, known as
IL-5R. The IL-5R consists of an alpha chain and a beta chain. Expression of
the IL-5R alpha chain is restricted largely to eosinophils, basophils, and
some mast cells in humans. The alpha-chain exclusively binds IL-5 and the
intracellular portion of IL-5Ralpha is involved in cellular activation. Thus,
the IL-5R alpha.chain may be a good target for a therapeutic antibody in the
management of asthma. Eosinophils, and perhaps basophils and some mast cells,
can be preferentially targeted for antibody-dependent cell cytotoxicity
through IL-5R alpha chain depleting cells thought to be key in disease
pathogenesis and severity. In addition, blocking of IL-5R alpha could provide
benefit by neutralizing effects of IL-5.
MedImmune's Clinical Development in Asthma
MedImmune has multiple approaches in development targeting asthma.
Currently, in human testing, the company has antibodies targeting IL-9 and
IL-13, in addition to the anti-IL-5R that is the subject of this press
release.
About Asthma
Asthma is a chronic disease of the airways that may cause wheezing,
breathlessness, chest tightness and coughing. According to the U.S. Centers
for Disease Control and Prevention, more than 30 million Americans reported
having a history of asthma in 2003, including nine million children. About 20
million said they currently had asthma. In 2000, the CDC reported that there
were more than 10 million asthma-related outpatient visits to private
physician offices and hospital clinics. The National Institutes of Health have
estimated asthma-related healthcare costs in the U.S. at $14 billion annually.
About MedImmune
MedImmune is a leading, innovation-focused biotechnology company whose
mission it is to provide better medicines to patients, new medical options for
physicians and rewarding careers to employees. Dedicated to advancing science
and medicine to help people live better lives, the company is focused on
infection, oncology, respiratory disease and inflammation, cardiovascular/
gastrointestinal disease and neuroscience. Headquartered in Gaithersburg,
Maryland, MedImmune has approximately 3,000 employees worldwide and is the
wholly owned biologics business for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN).
For more information, visit MedImmune's website at http://www.medimmune.com.
SOURCE MedImmune
CONTACT: Media, Sidoney Atse, +1-301-398-5990, or Investors, Peter
Vozzo, +1-301-398-4358, both of MedImmune