Medarex Announces Initiation of Phase I Clinical Trial for the Treatment of Psoriasis
Friday March 23, 12:17 pm ET
PRINCETON, N.J., March 23 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX - News) announced today that its partner MedImmune, Inc. has initiated a Phase I clinical trial of MEDI-545 for the potential treatment of psoriasis. MEDI-545 is a fully human antibody generated by Medarex's UltiMAb Human Antibody Development System®.
The Phase I dose-escalation trial for the treatment of psoriasis is expected to 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.
MEDI-545 is under evaluation for the treatment of systemic lupus erythematosus (SLE or lupus) in a Phase I clinical study also being conducted by MedImmune. The Phase I study in lupus will be the subject of a poster presentation at the 8th International Lupus Consortium, scheduled for May 24 - 26 in Shanghai. In addition, MedImmune has filed an application with the U.S. Food and Drug Administration for orphan drug status of MEDI-545 for an additional indication, idiopathic inflammatory myositis, an immunological disease that involves chronic muscle inflammation, pain and weakness.
"We are pleased with MedImmune's continued commitment to and progress with this antibody product candidate. We believe that the expansion of indications could lead to the development of therapeutics for a broad population of patients afflicted with serious autoimmune diseases," said Irwin Lerner, Chairman of the Board of Directors and Interim President and CEO of Medarex.
About MEDI-545
MEDI-545 (previously known as MDX-1103) is a fully human monoclonal antibody targeting interferon-alpha. Published 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.
In November 2004, MedImmune entered into a collaboration with Medarex 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. Prior to the beginning of pivotal studies, Medarex may elect to co-develop the products in return for the opportunity to co-promote and to receive a share of the commercial profits in the United States. In all other cases, Medarex will be entitled to receive milestone payments and royalties. |
