- Company Advances Anti-Inflammatory Clinical Program
with Antibody Targeting Interferon-Alpha -
GAITHERSBURG, Md., April 13 /PRNewswire-FirstCall/ -- MedImmune, Inc.
(Nasdaq: MEDI) announced today that it has begun dosing lupus patients in a
Phase 1 clinical trial to evaluate the safety and tolerability of MEDI-545,
its monoclonal antibody (MAb) targeting interferon-alpha. The MAb is being
developed for the potential treatment of patients with systemic lupus
erythematosus (SLE or lupus).
"Moving forward with our clinical program for MEDI-545 in lupus patients
is an exciting next step in our plan to develop new treatments for patients
suffering from inflammatory diseases," said Stanley Pillemer, M.D.,
MedImmune's senior director, clinical development, inflammatory disease. "With
this Phase 1 program, we look to further increase our knowledge about the role
of interferons in lupus disease activity, with the hope of developing a new
medical option for patients suffering from this debilitating disease."
MedImmune's Lupus Interferon Skin Activity (LISA) study is a Phase 1,
randomized, double-blind, placebo-controlled, dose-escalation study involving
a single intravenous dose of the anti-interferon-alpha antibody in patients
who have mild SLE with lupus rash or skin lesions. Forty-five individuals will
be enrolled at approximately 20 centers in North America.
MedImmune's development of MAbs targeting interferon-alpha stems from a
collaboration agreement entered into with Medarex, Inc. in 2004 to focus on
two specific antibodies, one of which was MDX-1103 (now known as MEDI-545).
Under the terms of the agreement, MedImmune is responsible for all ongoing
clinical development activities.
"We are pleased that the development of this product candidate continues
to advance toward potentially helping patients fight the effects of a serious
condition," said Donald L. Drakeman, president and CEO of Medarex.
About MEDI-545 (Anti-IFN-alpha MAb)
MEDI-545 is a fully human monoclonal antibody (MAb) targeting interferon-
alpha. Published preclinical data indicate that levels of interferon-alpha are
elevated in many patients with active systemic lupus erythematosus (SLE or
lupus) and other autoimmune disorders, and may be associated with disease
activity. Preclinical data from animal models suggest that MEDI-545 may
suppress the abnormal immune activity associated with lupus by binding to
multiple interferon-alpha subtypes seen in the serum of lupus patients.
Approximately 350,000 individuals in the United States are affected with
SLE, a chronic inflammatory disease that causes the body to attack its own
tissues and organs, including the skin, joints, blood and kidneys. Treatments
for lupus include anti-inflammatory drugs, antimalarials, corticosteroids and
drugs approved for other purposes, such as immunosuppressive agents given to
cancer patients undergoing chemotherapy or medicines developed to treat
arthritis patients. Lupus occurs about 10 times more frequently in adult
females than adult males, and is two to three times more common among African
Americans, Hispanics, Asians and Native Americans.
About MedImmune, Inc.
MedImmune strives to provide better medicines to patients, new medical
options for physicians, rewarding careers to employees, and increased value to
shareholders. Dedicated to advancing science and medicine to help people live
better lives, the company is focused on the areas of infectious diseases,
cancer and inflammatory diseases. With more than 2,200 employees worldwide,
MedImmune is headquartered in Gaithersburg, Maryland. For more information,
visit the company's website at http://www.medimmune.com.
This announcement may contain, in addition to historical information,
certain forward-looking statements that involve risks and uncertainties, in
particular, related to the research and development of antibodies targeting
interferon-alpha. Such statements reflect management's current views and are
based on certain assumptions about the success of this program. Actual results
could differ materially from those currently anticipated as a result of a
number of factors, including risks and uncertainties discussed in MedImmune's
filings with the SEC. MedImmune is developing interferon-alpha-related product
candidates for potential future marketing. There can be no assurance that such
development efforts will succeed, that such products will receive required
regulatory clearance or that, even if such regulatory clearance were received,
such products would ultimately achieve commercial success.
This press release can be found on MedImmune's website at
http://www.medimmune.com in the box marked "News" or with the archived press
releases on the Investor Summary page.
SOURCE MedImmune, Inc.
CONTACT: Investors: Peter Vozzo, +1-301-398-4358; Media: Kate Barrett,
+1-301-398-4320 or Jamie Lacey, +1-301-398-4035, all of MedImmune, Inc.