GAITHERSBURG, Md., Aug. 12 /PRNewswire/ -- MedImmune today announced that
it has initiated enrollment in a Phase 2A trial with an investigational human
monoclonal antibody (MAb) targeting interferon-alpha in patients with systemic
lupus erythematosus (SLE or lupus). The study is designed to assess the safety
and tolerability of the antibody, also known as MEDI-545 in patients with
moderately to severely active lupus, despite standard of care. Current
treatment options for moderately to severely active lupus include potent
immunosuppressive drugs that have unfavourable long-term adverse effects. Data
from patients with lupus and animal models of lupus suggest Type I interferons
play a key role in lupus, especially interferon-alpha. By blocking the effects
of interferon-alpha, MEDI-545 may provide a strategy for improving the signs
and symptoms associated with lupus.
"Lupus can be a debilitating disease that damages organs, causes pain and
loss of function, and reduces the quality of life in patients suffering from
the disease, who are often young women," said Barbara White, vice president,
clinical development, inflammatory disease. "The Phase 1 trials with this
antibody have demonstrated that it can inhibit activity of interferon-alpha in
patients with lupus and that its safety profile supports further clinical
development in lupus."
The Phase 2A clinical trial is designed to evaluate the safety and
tolerability of multiple subcutaneous dose schedules of MEDI-545 or placebo in
adult patients with moderately to severely active lupus. The study will also
assess the effects of MEDI-545 on disease activity in lupus patients. This
randomized, double-blind, placebo-controlled, parallel-dose trial will be
conducted at about 20 sites throughout the United States.
MEDI-545 was generated using the Medarex, Inc. Ultimab Human Antibody Development System(R).
Lupus is an autoimmune disease that can affect various parts of the body,
including the skin, joints, heart, lungs, blood, kidneys and brain. Lupus
affects approximately 322,000 to possibly over a million people in the United
States. Lupus may occur at any age in men or women, but the disease
predominantly affects women of childbearing years. The disease has a higher
incidence in African-Americans, Hispanics, Asian and American Indians.
Treatments for lupus include nonsteroidal anti-inflammatory drugs,
corticosteroids, antimalarials, and immunosuppressants.
MedImmune is wholly owned by AstraZeneca plc (LSE: AZN.L, NYSE: AZN) and
is the worldwide biologics business for the AstraZeneca Group. The company has
approximately 3,000 employees worldwide and is headquartered in Gaithersburg,
Maryland. MedImmune strives 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. For
more information, visit MedImmune's website at http://www.medimmune.com.
CONTACT: Media: Sidoney Atse, +1-301-398-5990, or Investors: Peter
Vozzo, +1-301-398-4358, both of MedImmune