¿ Alexion Pharmaceuticals Inc., of New Haven, Conn., started a Phase II efficacy trial with its anti-inflammatory complement inhibitor drug, 5G1.1, in patients with membranous nephritis, a form of kidney disease. The multicenter, double-blind, randomized, placebo-controlled study will examine the safety and efficacy of repeated dosing of 5G1.1 in about 150 patients. 5G1.1 is a novel fully humanized monoclonal antibody specifically designed to interfere in the complement cascade.
¿ Amersham Pharmacia Biotech, of Piscataway, N.J., signed an agreement with Beckman Coulter that will boost the screening potential of LEADseeker Homogenous Imaging System. The two companies will work together in automating LEADseeker, so it can screen 100,000 compounds a day for the majority of assay applications used by researchers.
¿ Aquila Biopharmaceuticals Inc., of Framingham, Mass., received an $870,000 two-year grant from the National Institutes of Health in Bethesda, Md., to support the development of novel vaccines for tuberculosis based on the CD1 immune enhancement technology. The CD1 system involves cells that use the CD1 molecules to present foreign antigens from infectious agents to stimulate T cells.
¿ Biomira Inc., of Edmonton, Alberta, started a Phase II study in Canada of BLP25 vaccine for advanced non-small-cell lung cancer. The trial in seven to 10 patients is being run to determine whether a higher dose and more frequent administration will enhance its effect. BLP25 vaccine incorporates a synthetic 25-amino acid sequence of the MUC-1 cancer mucin encapsulated in a synthetic liposomal delivery system.
¿ Eos Biotechnology Inc., of South San Francisco, and Medarex Inc., of Annandale, N.J., formed a collaboration involving the use of Medarex's HuMAb-Mouse technology for the generation of fully human antibodies to Eos' genomics-derived immunotherapeutic targets. Medarex could receive research payments, license fees and milestones as well as royalties on therapeutic product sales. Eos is allowed to access the HuMAb-Mouse technology for multiple targets. Eos is Medarex's 12th HuMAb partner.
¿ ImClone Systems Inc., of New York, started a 59-patient multicenter Phase II trial evaluating its lead cancer therapeutic, C225, in combination with the chemotherapeutic agent cisplatin in patients with refractory advanced squamous cell head and neck carcinoma. C225, a monoclonal antibody, is an inhibitor of the epidermal growth factor receptor, which is associated with cancer cell growth in a number of solid tumors. The company recently started two Phase III trials evaluating C225 in combination with chemotherapy and radiotherapy in patients with advanced squamous cell head and neck carcinoma.
¿ Immunomedics Inc., of Morris Plains, N.J., said the FDA gave orphan drug status to its yttrium-90-radiolabeled CEA-Cide cancer therapeutic for use in ovarian cancer. CEA-Cide is a humanized monoclonal antibody against carcinoembryonic antigen, which is expressed in many solid tumors.
¿ NexMed Inc., of Robbinsville, N.J., said its proprietary alprostadil (prostaglandin E1) cream for treating male erectile dysfunction showed an efficacy rate of 75 percent in the those with mild to moderate dysfunction. The study in China included 56 subjects. Primary efficacy was assessed as the number of intercourse successes per the total number of intercourse attempts.
¿ Novavax Inc., of Columbia, Md., acquired substantially all of the assets, excluding cash and accounts receivable, of the Biomedical Services Laboratory division of DynCorp, of Reston, Va. The division is engaged in contract research, development and pilot manufacturing of human vaccines for government laboratories and other vaccine companies.
¿ Quest Diagnostics Inc., of San Diego, and Structural Bioinformatics Inc., of San Diego, formed a strategic alliance regarding the application of structural phamacogenomics to clinical testing and pharmaceutical research. Structural pharmacogenomics is the analysis of structural variations of drug targets resulting from genetic variations within a population. SBI will extend existing and generate new proprietary target-specific structural variant database modules for a number of therapeutic targets based on Quest Diagnostics' clinical sequence databases.
¿ Techniclone Corp., of Tustin, Calif., said that Carolina Neurosurgey & Spine was added as a site for its ongoing Phase II Cotara trial for the treatment of malignant glioma or solid tumor brain cancer. Patient enrollment should start at the center next month.
¿ The Liposome Co. Inc., of Princeton, N.J., entered into a collaboration with Rhone-Poulenc Rorer Pharmaceuticals Inc., of Collegeville, Pa., involving a clinical study to evaluate the safety and efficacy of Evacet in combination with Taxotere (docetaxel) for the first-line treatment of metastatic breast cancer. Evacet (TLC D-99) is a proprietary liposomal formulation of the anticancer drug doxorubicin.