Medarex Announces Advancement of Antibody Development by Partner
PRINCETON, N.J., July 19 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX - News) announced today that its partner MedImmune, Inc. has initiated a Phase Ib multi-dose clinical trial of MEDI-545 for the potential treatment of systemic lupus erythematosus (SLE or lupus). MEDI-545 is a fully human antibody generated by Medarex's UltiMAb Human Antibody Development System®.
MedImmune is also evaluating MEDI-545 in a Phase I single-dose trial in lupus patients and a Phase I dose-escalation trial in psoriasis patients. Preliminary data from the Phase I single-dose trial in lupus showed an acceptable safety profile and tolerability of MEDI-545 in patients, as presented at the 8th International Lupus Consortium, held May 24-26, 2007 in Shanghai. MedImmune plans to begin an additional trial for MEDI-545 in idiopathic inflammatory myositis, an immunological disease that involves chronic muscle inflammation, pain and weakness.
"We are pleased with the advances that MedImmune continues to make in the development of MEDI-545. We believe that the ongoing studies as well as studies in new indications hold the promise of delivering new therapeutic options to patients living with autoimmune diseases," said Howard H. Pien, 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 SLE 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. |
