MedImmune Initiates First Phase 2 Trial In Lupus Patients With Its Antibody Targeting Interferon-alpha

Main Category: Lupus
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 13 Aug 2008 - 2:00 PDT

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MedImmune 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 by immunizing the Medarex transgenic HuMab-Mouse(R) with natural human interferon-alpha.

About Lupus

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.

About MedImmune

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.

MedImmune
http://www.medimmune.com