MedImmune Begins Dosing Of Lupus Patients In Phase 1 Clinical Trial

Main Category: Lupus
Also Included In: Clinical Trials / Drug Trials;  Immune System / Vaccines
Article Date: 14 Apr 2006 - 0:00 PDT

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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.

About Lupus

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.

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.

MedImmune, Inc.
http://www.medimmune.com

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