View Full Version : MedImmune Expands Anti-Interferon-Alpha Program By Initiating Phase 1 Trial In Patien

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03-24-2007, 09:05 AM
MedImmune, Inc. (Nasdaq: MEDI) today announced that it has initiated a Phase 1 trial with its monoclonal antibody (MAb) targeting interferon-alpha, known as MEDI-545, in patients with psoriasis. Signaling an expanded focus on the role of interferons in inflammatory diseases, the psoriasis trial marks a second clinical study underway with MEDI-545, which is also being evaluated in an ongoing Phase 1 trial in patients with systemic lupus erythematosus (SLE or lupus).

"MedImmune is committed to developing innovative new treatments for patients who suffer from debilitating inflammatory diseases," said Barbara White, M.D., senior director, clinical development, inflammatory diseases. "It is exciting to expand our evaluation of MEDI-545 to patients with psoriasis. We are encouraged by the progress of MEDI-545 to date, and hope to further our understanding about the role of type 1 interferons in the pathology of immunological diseases like psoriasis and lupus."

A growing body of preclinical data suggests that type-1 interferons are involved in a range of chronic inflammatory diseases. Elevated type-1 interferon mRNA levels have been found in preclinical models of psoriasis, and inhibition of type 1 interferon in these models has been shown to block the development of psoriasis. Preclinical study results have also demonstrated that interferon-alpha-induced genes and proteins are over-expressed in the skin in animal models of psoriasis.

Designed to evaluate safety and tolerability, MedImmune's Phase 1 dose- escalation trial will be conducted at three sites in North America. Patients will be dosed once and subsequently evaluated for a period of 126 days, including blood and skin analysis at regular intervals.

MedImmune is advancing its anti-interferon-alpha program on several other fronts. The company's ongoing Phase 1 study in lupus patients will be the subject of a poster presentation at the 8th International Lupus Consortium, to be held May 24-26 in Shanghai. The single-dose study was initiated by MedImmune in April 2006, based on preclinical research conducted in collaboration with its partner, Medarex, Inc. In addition to preclinical data suggesting that elevated levels of interferon alpha may be associated with lupus disease activity, preclinical study results also indicated 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.

Additionally, MedImmune recently filed an application with the U.S. Food and Drug Administration (FDA) for MEDI-545 to be granted orphan drug status in a third indication, idiopathic inflammatory myositis. An area of unmet medical need, idiopathic inflammatory myositis is an immunological disease that involves chronic muscle inflammation, pain and weakness.

About Psoriasis

Psoriasis is an immunological disease affecting as many as 7.5 million Americans, according to the National Institutes of Health (NIH). Plaque psoriasis, the most common type of psoriasis, is characterized by the formation of lesions, or inflamed patches of skin. The severity of psoriasis can range from a small number of lesions to more severe cases involving moderate to large areas of skin. Psoriasis occurs nearly equally in men and women and can develop at any age, commonly appearing between ages 15 and 35. Approximately 10 to 30 percent of people with psoriasis will develop psoriatic arthritis, according to the National Psoriasis Foundation. In psoriatic arthritis, the joints and the soft tissue around them become inflamed and stiff, affecting the fingers and toes and possibly involving the neck, lower back, knees and ankles. In severe cases, psoriatic arthritis can be disabling and cause irreversible damage to joints.

About Lupus

Approximately 350,000 individuals in the United States are affected with lupus, 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 disease, cancer and inflammatory diseases. With more than 2,500 employees worldwide, MedImmune is headquartered in 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.

MedImmune, Inc.