¿ Centocor Inc., of Malvern, Pa., Pharmacia & Upjohn, of Bridgewater, N.J., and Eli Lilly and Co., of Indianapolis, disclosed an expanded sub-study to an international clinical trial evaluating the safety and efficacy of ReoPro (abciximab) in the treatment of acute coronary syndrome. ReoPro is a dual-affinity inhibitor of glycoprotein IIb/IIIa and alpha V beta 3 receptors. The goal of the study is to compare ReoPro to standard therapy in reducing the composite endpoint of death or myocardial infarction when percutaneous coronary intervention is not planned. The anti-platelet agent ReoPro is marketed in the U.S. by Centocor and Lilly.
¿ Genelabs Inc., of Redwood City, Calif., said its drug for the treatment of systemic lupus erythematosus, GL701, has been granted fast-track status by the FDA. The orally administered therapy is in Phase III trials.
¿ Idec Pharmaceuticals Inc., of San Diego, began a Phase II clinical study of its humanized monoclonal antibody, IDEC-131, which targets the CD40 ligands (also known as gp39 or CD154), found primarily on activated T cells. The study will be in patients with systemic lupus erythematosus.
¿ Ligand Pharmaceuticals Inc., of San Diego, signed marketing and distribution agreements with Ferrer Internacional S.A., of Barcelona, Spain, for exclusive rights in Spain, Portugal, Greece, and Central and South America for Ligand¿s five near-term oncology products: Ontak; Panretin gel and capsules; and Targretin gel and capsules.
¿ MGI Pharma Inc., of Minneapolis, began enrolling patients in a Phase II study of MGI 114, its drug for pancreatic cancer. The drug is the lead compound in a family of cytotoxic agents, called the acylfulvenes, that seem to have a synergistic effect when used in combination with certain approved drugs. The study will include about 50 patients with advanced pancreatic cancer.
¿ Nanogen Inc., of San Diego, initiated its first beta site and signed agreements with two more institutions. The first molecular identification system was shipped to the University of Texas Southwestern Medical Center, in Dallas. Two more beta sites, at the Mayo Clinic and the Bode Technology Group, a forensic laboratory, are expected to begin in the coming months. The beta sites represent a cross-section of potential users for Nanogen¿s technology in the analysis of single-nucleotide polymorphisms and repetitive DNA sequences.
¿ Sangstat Corp., of Menlo Park, Calif., filed for marketing authorization in the U.K. for its SangCya capsules to prevent rejection in solid-organ transplant recipients. The filing follows the January approval in the U.K. for SangCya as an oral cyclosporine solution for use in that indication as well as autoimmune diseases.