• Affymetrix Inc., of Santa Clara, Calif., said new versions of its GeneChip Escherichia coli and yeast genome arrays are available. The arrays are designed to offer updated genomic content, as well as three new strains of E. coli and one new species of yeast, expanding their use for gene-expression research.

• ArQule Inc., of Woburn, Mass., discovered a series of orally active inhibitors of RAF kinases with antitumor activity in a xenograft human cancer model. The program comprises a series of compounds that inhibit both B-RAF and c-RAF kinases in the nanomolar range, and the company plans to file an investigational new drug application between the end of next year and the second quarter of 2006.

• Bioenvision Inc., of New York, said emerging data reported at the Leukemia 2004 meeting in Houston showed that the use of clofarabine as first-line monotherapy in older adult patients with acute myeloid leukemia, who were considered unsuitable for intensive chemotherapy, produced a median duration of response of six months. Interim data, previously presented at the European Haematology Association meeting in June, showed a complete response rate of 64 percent in that group of patients.

• Biogen Idec Inc., of Cambridge, Mass., reported that Health Canada authorized Amevive (alefacept) for sale in Canada. Amevive, the first biologic approved for psoriasis in Canada, will be marketed for the treatment of patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. Amevive became the first approved biologic therapy for the treatment of moderate to severe chronic plaque psoriasis when it was approved in the U.S. in 2003. (See BioWorld Today, Feb. 3, 2003.)

• Biolog Inc., of Hayward, Calif., received a Phase II Small Business Innovation Research grant of $2.5 million from the National Institutes of Health in Bethesda, Md. The grant is expected to be used to extend the company's Phenotype MicroArray assay platform in toxicological cell-based assays. The company already developed a battery of cell assays with its technology for use with human and mouse cell lines under the Phase I portion of the grant.

• Biomax Informatics AG, of Martinsried, Germany, said a consortium of venture capital companies invested €2.25 million (US$2.8 million) in Biomax. Biomax develops customizable bioinformatics solutions.

• Cell Genesys Inc., of South San Francisco, is planning to offer, subject to market and other conditions, $100 million principal amount of convertible senior notes due 2011. The company also expects to grant initial purchasers a 30-day option to purchase up to an additional $25 million principal amount of the notes. Cell Genesys intends to use the net proceeds primarily to repay two outstanding bank loans totaling $95 million, thereby eliminating existing restrictions on about $60 million of the company's current cash balance. Cell Genesys' stock (NASDAQ:CEGE) fell $1.09 Wednesday, or 12.8 percent, to close at $7.42.

• Critical Therapeutics Inc., of Lexington, Mass., completed a Phase I study of CTI-01, the company's anti-inflammatory drug candidate being developed for the treatment of critical inflammatory conditions. The double-blind, randomized, placebo-controlled, multiple-exposure study began in July. CTI-01 was administered to 60 healthy subjects. CTI-01 was safe and well tolerated at doses in excess of the therapeutic range seen in preclinical models of inflammatory disease.

• Elusys Therapeutics Inc., of Pine Brook, N.J., said the federal government would provide additional funding for Anthim, its antibody treatment for exposure to anthrax toxin. Elusys will receive $5 million from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health in Bethesda, Md., to support the clinical development of Anthim (also known as ETI-204) and enable the study of the drug's safety in humans and its efficacy in primates. A $3.5 million grant from the Department of Defense is focused on research into different methods of administration that might be faster and more convenient than intravenous injection, measurement of the length of the drug's protection following exposure and refinements to the production process to expedite the availability of larger quantities of Anthim.

• eXegenics Inc., of Pittsford, N.Y., said its securities would be delisted from the Nasdaq Stock Market effective today. Its stock will not be immediately eligible to trade on the Over-the-Counter Bulletin Board, though, given that a Nasdaq listings qualification panel determined that the delisting was based on concerns under Nasdaq Marketplace Rule 4330.

• Human Genome Sciences Inc., of Rockville, Md., began dosing patients in a pair of Phase II trials of HGS-ETR1. One tests the product, an agonistic human monoclonal antibody to TRAIL receptor-1, in patients with advanced non-Hodgkin's lymphoma, while the other evaluates its use in advanced colorectal cancer patients. Both will enroll a maximum of 30 patients, and each patient will receive up to six cycles of treatment in the absence of disease progression. The objectives of the NHL study are to evaluate disease activity and tumor response to HGS-ETR1, to evaluate the product's safety and tolerability and to determine plasma concentrations of HGS-ETR1 for use in a population pharmacokinetic analysis. The primary objective of the colorectal cancer study is to evaluate tumor response, while secondary objectives will evaluate safety and tolerability, determine plasma concentrations for use in a population pharmacokinetic analysis, and to evaluate other indicators of disease activity, such as time to response, duration of response and progression-free survival.

• Juvaris BioTherapeutics Inc., of Pleasanton, Calif., began evaluating the efficacy of the JuvImmune immunostimulant platform in PuntaToro virus infection models in conjunction with researchers at the Institute for Antiviral Research of Utah State University sponsored by the National Institute of Allergy and Infectious Diseases. The company anticipates testing the JuvImmune platform in other viral model systems upon demonstration of efficacy in the PuntaToro virus model. Juvaris said JuvImmune is capable of activating the innate immune response for the production of antiviral interferons, as well as IL-12 and TNF-alpha.

• MedImmune Inc., of Gaithersburg, Md., said preclinical data published in this month's issue of the Journal of Virology showed that its lead vaccine candidate to prevent respiratory syncytial virus and parainfluenza virus Type 3 has a protective immune response against both viruses in animals. The company added that the results support the continued development of vaccine candidates. The data also serve as a platform for the development of other vaccines to protect infants from various respiratory infections. MedImmune said it plans to file an investigational new drug application to begin clinical testing of a RSV/PIV-3 vaccine candidate by the end of the year.

• Metabolon Inc., of Research Triangle Park, N.C., announced the final close of a $9 million Series A round of financing. The company said it would use the funds to further invest in its metabolomics technology. The financing was led by Sevin Rosen Funds, with participation from existing investors. The company closed on an initial $4 million in July, led by the Aurora Funds, with participation from the Trelys Funds, Alexandria Real Estate Equities and other investors. In connection with the financing, Sevin Rosen's John Oxaal is joining Metabolon's board.

• Migenix Inc., of Vancouver, British Columbia, began enrolling chronic hepatitis C virus patients in a Phase II study of MX-3253. About 60 treatment-naive or interferon-intolerant patients (genotype I), divided into three dosing groups, will be treated at five Canadian sites. Its objective is to evaluate viral loads at various time points during the study and at 12 weeks, and also to assess safety. The company said it expects results in the second quarter. Other studies also are being planned to evaluate MX-3253 in combination with marketed products.

• Nabi Biopharmaceuticals, of Rockville, Md., said StaphVAX (Staphylococcus aureus polysaccharide conjugate vaccine) was named a fast-track product by the FDA for the prevention of S. aureus bloodstream infections in end-stage renal disease patients. The product is in a confirmatory Phase III trial.

• Norak Biosciences Inc., of Research Triangle Park, N.C., signed a screening services agreement with Purdue Pharma LP, of Stamford, Conn., to use Norak's Transfluor technology for G protein-coupled receptor (GPCR)-based drug discovery. Norak will develop Transfluor cell lines expressing an orphan GPCR target of interest to Purdue and then screen the cell line in its high-throughput screening facility against a Purdue compound library. Financial details were not disclosed.

• Northfield Laboratories Inc., of Evanston, Ill., said an independent data monitoring committee recommended that its pivotal Phase III trial of PolyHeme continue without modification following a second planned interim analysis. The committee found no concerns to alter the protocol after a review of blinded data on mortality and serious adverse events in the first 120 patients enrolled in the study, which is designed to evaluate Northfield's human hemoglobin-based oxygen carrier when administered to patients in hemorrhagic shock following traumatic injury.

• Nucleonics Inc., of Horsham, Pa., secured a $2.7 million equipment financing facility through Oxford Finance Corp., of Alexandria, Va. Nucleonics is focused on the development of RNA interference-based therapeutics for viral and other diseases.

• Valera Pharmaceuticals Inc., of Cranbury, N.J., said the FDA approved Vantas, its long-acting implant indicated for the palliative treatment of advanced prostate cancer. Using the company's Hydron Implant technology, Vantas is designed for the continuous 12-month administration of histrelin, a synthetic nonapeptide agonist of luteinizing hormone-releasing hormone.

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