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The Phase 2A clinical trial is designed to evaluate the safety andtolerability of multiple subcutaneous dose schedules of MEDI-545 or placebo inadult patients with moderate to severe active lupus. The study will alsoassess the effects of MEDI-545 on disease activity in lupus patients. Thisrandomized, double-blind, placebo-controlled trial is expected to enroll 80patients and will be conducted at 20 sites in the United States.
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MedImmune is also conducting a Phase 1 clinical trial for MEDI-545 inidiopathic inflammatory myositis, an immunological disease that involveschronic muscle inflammation, pain and weakness.
"Data from an earlier reported placebo-controlled Phase 1 study suggestedtherapeutic activity with single doses in patients with lupus and demonstratedan acceptable safety profile," said Geoffrey M. Nichol, M.B.Ch.B., Senior VicePresident of Product Development at Medarex. "We are very excited about therole of the interferon alpha inflammatory pathway and look forward toexploring its potential in treating patients with lupus and other autoimmunediseases."
About MEDI-545
MEDI-545 (previously known as MDX-1103) is a fully human monoclonalantibody targeting interferon-alpha. Published data indicate that levels ofinterferon-alpha are elevated in many patients with active SLE and otherautoimmune disorders, and may be associated with disease activity. Preclinicaldata from animal models suggest that MEDI-545 may suppress the abnormal immuneactivity associated with lupus by binding to multiple interferon-alphasubtypes seen in the serum of lupus patients.
In November 2004, MedImmune entered into a collaboration with Medarex tofocus on two specific antibodies, one of which was MDX-1103 (now known asMEDI-545). Under the terms of the agreement, MedImmune is responsible for allongoing clinical development activities. Prior to the beginning of pivotalstudies, Medarex may elect to co-develop the products in return for theopportunity to co-promote and to receive a share of the commercial profits inthe United States. In all other cases, Medarex will be entitled to receivemilestone payments and royalties.
About Lupus
Approximately 350,000 individuals in the United States are affected withlupus, a chronic inflammatory disease that causes the body to attack its owntissues and organs, including the skin, joints, blood and kidneys. Treatmentsfor lupus include anti-inflammatory drugs, antimalarials, corticosteroids anddrugs approved for other purposes, such as immunosuppressive agents given tocancer patients undergoing chemotherapy or medicines developed to treatarthritis patients. Lupus occurs about 10 times more frequently in adultfemales than adult males, and is two to three times more common among AfricanAmericans, Hispanics, Asians and Native Americans.
About Medarex
Medarex is a biopharmaceutical company focused on the discovery,development and potential commercialization of fully human antibody-basedtherapeutics to treat life-threatening and debilitating diseases, includingcancer, inflammation, autoimmune disorders and infectious diseases. Medarexapplies its UltiMAb(R) technology and product development and clinicalmanufacturing experience to generate, support and potentially commercialize abroad range of fully human antibody product candidates for itself and itspartners. More than 40 of these therapeutic product candidates derived fromMedarex technolo
