¿ Affymetrix Inc., of Santa Clara, Calif., saw its stock gain 31 percent Wednesday after it reported total revenue of $55.8 million for the third quarter, an 89 percent increase over the same period last year. Affymetrix reported net income of $295,000 for the third quarter, compared to a net loss of $5.8 million in the same quarter 1999. It reported 11 cents in earnings per share, as opposed to consensus analyst estimates of a 12-cent loss. Product sales went up 74 percent, the result of increased sales of GeneChip probe arrays, increased subscription fees and increased placements of instruments. Affymetrix's stock (NASDAQ:AFFX) jumped $16.04 Wednesday to close at $68.359.
¿ Allos Therapeutics Inc., of Denver, said two Phase II trials of RSR13 combined with cranial radiation therapy in patients with glioblastoma multiforme or brain metastases showed statistically significant extended survival data. Preliminary data were presented in May. Extended results from the Phase II trials showed a median survival of RSR13-treated patients at 12.3 months compared to the control group of 9.7 months (p<0.04). Allos is reviewing plans for a Phase III trial of the drug with cranial radiation therapy in newly diagnosed glioblastoma multiforme. A Phase III trial for brain metastases is under way.
¿ Antex Biologics Inc., of Gaithersburg, Md., said its subsidiary, AntexPharma, entered a worldwide, exclusive licensing agreement with the University of Maryland in College Park for the development and marketing of antibiotic peptides to combat antibiotic-resistant bacteria. Antex will fund preclinical and clinical development of the peptides and will pay UM royalty payments upon commercialization in return for marketing rights.
¿ Cell Therapeutics Inc., of Seattle, received orphan medicinal product designation from the European Commission through the European Agency for the Evaluation of Medicinal Products for its Trisenox (arsenic trioxide) injection for treatment of acute promyelocytic leukemia. Cell Therapeutics anticipates filing for marketing approval in the EU in the fourth quarter.
¿ Cerus Corp., of Concord, Calif., and Baxter Healthcare Corp., of Deerfield, Ill., initiated a Phase Ic trial of the Intercept Red Blood Cell System, a pathogen-inactivation system for blood intended for transfusion. The two-part, parallel trial will include a 30-patient, randomized, crossover arm designed to compare the post-transfusion recovery and survival characteristics of Intercept pathogen-inactivated red blood cells to untreated red blood cells, and a safety and tolerability arm of full-unit transfusions of Intercept red blood cells in 10 participants.
¿ CollaGenex Pharmaceuticals Inc., of Newtown, Pa., agreed with ISDIN SA, of Spain, to extend marketing rights for Periostat, CollaGenex's periodontal disease therapeutic, to include Greece. ISDIN and CollaGenex entered a marketing agreement in April for Periostat that included Spain and Portugal.
¿ Corning Inc., of Corning, N.Y., entered a comprehensive research agreement with the Whitehead Institute for Biomedical Research to develop tools for life science research, most likely gene expression analysis tools initially. Corning recently entered the DNA microarray market.
¿ Cubist Pharmaceuticals Inc., of Cambridge, Mass., said it completed its acquisition of TerraGen Discovery Inc., of Vancouver, British Columbia, for $29 million in stock. The acquisition, a 608,000-share deal, will expand Cubist's anti-infective development and marketing operations, adding compounds, including Cidecin, or daptomycin, a novel cyclic lipopeptide antibiotic derived from S. roseosporus, to Cubist's development pipeline. (See BioWorld Today, Aug. 9, 2000.)
¿ Genelabs Technologies Inc., of Redwood City, Calif., said its new drug application for Aslera (GL701, prasterone) received priority review designation from the FDA. In double-blind, placebo-controlled Phase III trials, Aslera, its treatment for systemic lupus erythematosus (SLE), showed the ability to improve SLE and reduce steroid requirements in women with lupus.
¿ Genomica Corp., of Boulder, Colo., launched its LinkMapper software, marketed by Applied Biosystems Inc., of Foster City, Calif. It said LinkMapper is the first next-generation bioinformatics product based on a Java and Oracle technology platform. The genotyping tool is designed for use with AB's ABI Prism GeneMapper High Performance Genotyping software for genotyping management and analysis.
¿ Incara Pharmaceuticals Inc., of Research Triangle Park, N.C., researchers described hepatic (liver) stem cells for the first time in the Oct. 24, 2000, edition of the Proceedings of the National Academy of Sciences. The paper describes the stem cells' antigenic profile, methods of purification and culture conditions.
¿ Isis Pharmaceuticals Inc., of Carlsbad, Calif., initiated Phase I clinical studies of ISIS 104838, a novel antisense treatment for inflammatory and autoimmune diseases including rheumatoid arthritis and Crohn's disease. ISIS 104838 is a tumor necrosis factor-alpha inhibitor, and the clinical program is designed to evaluate the drug's safety and efficacy when administered intravenously and subcutaneously.
¿ Ixion Biotechnology, of Alachua, Fla., received a $100,000 Phase I Small Business Innovation Research grant for development of an Oxalobacter formigenes diagnostic kit. O. formigenes, an anaerobic bacterium found in the human intestinal tract, when absent, is related to idiopathic recurrent calcium-oxalate stone disease and hyperoxaluria.
¿ Oxford GlycoSciences plc, of Oxford, UK, said the European Commission designated OGT 918 (Vevesca) an orphan medicinal product for the treatment of Gaucher's disease. Designation as an orphan medicinal product in the EU allows direct access to the European Agency for the Evaluation of Medicinal Products' Centralized Procedure for Marketing Authorization Application, and may allow for a partial or total application fee waiver in addition to a 10-year marketing exclusivity period in the EU following approval.
¿ Pharmacyclics Inc., of Sunnyvale, Calif., said results from the lead-in phase of its ongoing Phase III clinical trial of Xcytrin (motexafin gadolinium) injection for treatment of cancer patients with brain metastases indicate the drug improves local control in the brain, with few patients experiencing neurologic progression, neurocognitive deterioration or death due to tumor progression, researchers told the 42nd Annual Meeting of the American Society of Therapeutic Radiology and Oncology in Boston. Tumor response, defined as at least a 65 percent reduction in tumor volume measured by MRI, was seen in 13 of 19 patients evaluable by MRI scans, with a median reduction in tumor volume of 83 percent. Seventy-seven percent of all 25 patients were free from neurologic progression.
¿ Synaptic Pharmaceutical Corp., of Paramus, N.J., said it discovered a gene and a corresponding neuroreceptor that showed potential as a therapeutic target for depression. The drug candidates identified by Synaptic as active on the neuroreceptor differ from most antidepressants, which act as uptake blockers on neurotransporters.
¿ Waratah Pharmaceuticals Inc., of Calgary, Alberta, said it entered into a license agreement with Research Corp. Technologies, of Tucson, Ariz., for the use of RCT's patented protein expression system for the production of Waratah's therapeutic proteins. Waratah will pay RCT royalties on net sales, including minimum annual royalties. Terms were not disclosed.