• Acacia Research Corp., of Newport Beach, Calif., said its CombiMatrix group has made commercially available the first microarray designed for the H5N1 "bird flu" influenza A virus. The World Health Organization in Geneva appealed Tuesday for technical assistance and expert advice to help stop the threat to humans and agriculture posed by the virus. CombiMatrix's microarray allows for the identification of the H5N1 virus and also is designed to allow the tracking of mutations that can occur in its genetic makeup as it goes through patterns of bird and human infection.

• Acuity Pharmaceuticals, of Philadelphia, reported publication of the Reich-Tolentino patent application covering small interfering RNA and its therapeutic uses targeted to vascular endothelial growth factor (VEGF) and two of its cellular receptors. Acuity is developing siRNA for the treatment of age-related wet macular degeneration (AMD) and diabetic retinopathy. In preclinical testing, Acuity's lead product, called Cand5, shut down the production of VEGF, the central factor in the development of neovascularization and vascular leakage in AMD. Data demonstrating the efficacy and safety of Cand5 in reducing blood vessel overgrowth and vascular leakage in a nonhuman primate model of AMD will be published in February in Retina.

• Affymetrix Inc., of Santa Clara, Calif., reported its fourth-quarter and year-end earnings. It had net income of about $16 million, or 27 cents per share and 26 cents per diluted share in the fourth quarter, up from $2.9 million or 5 cents per basic and diluted share in 2002. For the year, the company reported net income of about $14.3 million, or 24 cents per basic and diluted share, compared to a net loss in 2002 of $1.6 million, or 3 cents per basic and diluted share. It had about $459.9 million in cash, cash equivalents and available-for-sale securities as of Dec. 31. Its stock (NASDAQ:AFFX) jumped $4.32 Thursday, or 15.9 percent, to close at $31.45.

• Alexion Pharmaceuticals Inc., of Cheshire, Conn., said Phase IIb data of eculizumab in rheumatoid arthritis showed the primary endpoint was achieved with statistical significance. The endpoint was the improvement in ACR20 score after a six-month treatment period. The trial enrolled about 350 patients with chronic disease undergoing treatment with methotrexate or leflunomide. Eculizumab treatment also appeared to be safe and well tolerated, with the most common adverse events being upper respiratory tract infection, headache and nausea.

• Avanir Pharmaceuticals, of San Diego, and VaxGen Inc., of Brisbane, Calif., entered a cross-license and research collaboration to develop and manufacture preclinical supplies of a monoclonal antibody candidate for anthrax infection. The collaboration will combine Avanir's expertise to discover, characterize and develop anthrax antibodies with VaxGen's cGMP protein manufacturing capability and experience.

• BioBalance Corp., of New York, completed a safety trial of Probactrix in 125 healthy adult human volunteers at an intake level 10 times higher than normal for eight weeks. The biotherapeutic agent, intended for the dietary management of irritable bowel syndrome, was found to be well tolerated, and no adverse events attributable to the product were reported. BioBalance is a wholly owned subsidiary of New York Health Care.

• BioTrove Inc., of Woburn, Mass., raised $10.9 million in venture capital funding with investors Catalyst Health and Technology Partners, CB Health Ventures, Zero Stage Capital and BioFrontier Partners. The funds will be used to continue the development and commercialization of the micro- and nanoscale products and services, the Living Chip and Momentum assay development and screening.

• Cephalon Inc., of West Chester, Pa., selected Reading, UK-based Cognitive Drug Research Ltd.'s Computerized Cognitive Function Assessment System for inclusion in four Phase III trials of the R-isomer of modafinil. The system is being used to assess the degree to which the R-isomer of modafinil effects cognitive function in the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and chronic shift-work sleep disorder.

• Cyclacel Ltd., of Dundee, Scotland, raised $39 million in a Series D private placement with 20 new and existing institutional investors. Investors included Societe Generale Asset Management Alternative Investments, Carnegie Fund, DC Thomson & Co, NIF Ventures Quest for Growth, UOB Venture Technology Investments, BankInvest Asset Management, Biomedical Sciences Investment Fund-EDB Investments, Finsbury Life Sciences Investment Trust, International Life Sciences, HBM Partners, Invesco Private Capital, Lloyds Development Capital, GeneChem Management, Merifin Capital, Merlin Biosciences, Noble Grossart, Northern Ventures, Quester Capital Management, Scottish Equity Partners and Temasek Holdings. The company has raised a total of $123 million since its inception. Proceeds will go toward the development of CYC202 for non-small-cell lung cancer, breast cancer and glomerulonephritis, and of CYC682 in cancer, as well as for the preclinical development of drugs for oncology, HIV/AIDS and Type II diabetes indications.

• CytRx Corp., of Los Angeles, and Advanced BioScience Laboratories Inc., of Kensington, Md., filed an investigational new drug application for a Phase I trial of a new HIV vaccine formulation developed by the University of Massachusetts Medical School and Advanced BioScience Laboratories.

• Emisphere Technologies Inc., of Tarrytown, N.Y., reported preliminary results from the first multidose clinical study of an oral insulin tablet using its eligen technology. The 13-patient study evaluated the safety, effect and tolerability of the tablets when administered four times daily over a two-week period. Study results demonstrated the repeated administration of Emisphere's oral insulin was not associated with hypoglycemic events. The study enrolled Type II diabetic patients treated with diet alone. Patients receiving Emisphere's oral insulin tablets showed improvement when compared to baseline levels on key testing parameters, including fasting blood glucose, two-hour post-load glucose following an oral glucose tolerance test and serum fructosamine levels.

• Genzyme Corp., of Cambridge, Mass., received Japanese marketing approval for Fabrazyme (agalsidase beta) in Fabry's disease. The company, which estimates there are several hundred such patients in Japan with the disease, expects to launch Fabrazyme as soon as Japanese officials establish a local market price for the product.

• KV Pharmaceutical Co., of St. Louis, said it has completed Phase II studies of an endometriosis product with its licensing partner FemmePharma Inc., of Wayne, Pa. It also began Phase III studies. KV completed an additional purchase of $3 million of FemmePharma's convertible preferred stock under the terms of the agreement, raising KV's total convertible preferred stock investment to $5 million.

• Merrimack Pharmaceuticals Inc., of Cambridge, Mass., was awarded a Phase I Small Business Innovation Research grant from the National Cancer Institute in Bethesda, Md. The grant supports the development and application of Merrimack's microarray-based Network Biology discovery platform to the areas of apoptosis and cancer. Merrimack is focused on discovering and developing treatments for autoimmune disease and cancer.

• Nanobac Pharmaceuticals Inc., of Tampa, Fla., named Alexander Edwards president and CEO, and also appointed him to its board. Most recently, he was a managing partner of 360 Partners and the president and CEO of 360 Energy. Nanobac is developing diagnostic tests for the detection of nanobacterial infection and developing medications to treat the underlying cause of atherosclerosis and coronary heart disease.

• QLT Inc., of Vancouver, and Novartis Pharma AG, Ophthalmics, of East Hanover, N.J., a unit of Novartis AG, said Medicare will cover Visudyne for age-related macular degeneration with occult and minimally classic lesions that are four disc areas or less in size and have evidence of recent disease progression. Medicare already covers Ocular Photodynamic Therapy in AMD with predominantly classic lesions. QLT's stock (NASDAQ:QLTI) rose $4.51 Thursday, or 25.4 percent, to close at $22.29.

• Sumitomo Corp. of America, of New York, entered a definitive agreement to acquire Oxford Finance Corp., of Alexandria, Va., for cash and debt totaling about $85 million. Both companies have approved the agreement, which they expect to close next quarter. Oxford, a financial services company serving the life science industry, said the transaction would increase its access to the Japanese life science community.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., said findings published in the Jan. 30, 2004, issue of Molecular Cell reveal the first crystal structure of Flt-3, a member of the receptor tyrosine kinase family that is implicated in the development and progression of leukemia. The company said the study provides insight into the mechanism by which mutated forms of the Flt-3 receptor can activate themselves and trigger uncontrolled proliferation of immature blood cells, a common feature of several types of leukemia. Vertex scientists hypothesize that specific mutations cause Flt-3's juxtamembrane domain to adopt a conformation that enables the receptor to phosphorylate itself, resulting in uncontrolled cellular proliferation.

• Vical Inc., of San Diego, secured a license from the Centers for Disease Control and Prevention in Atlanta to technology used in a human DNA vaccine for West Nile virus. Vical is developing the vaccine under a Cooperative Research and Development Agreement with the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health in Bethesda, Md. The CDC license gives Vical additional rights to commercialize the vaccine, which also uses Vical's patented gene-delivery technology.

• Xencor Inc., of Monrovia, Calif., said findings published in the Jan. 29, 2004, issue of Nature reveal the structure of BAFF, also called BLyS or TALL-1, a regulator of immune function and a key target in autoimmune disease. Its scientists demonstrated that BAFF's biologically active form is trimeric, similar to other members of the TNF superfamily of proteins, a finding that could resolve conflicting reports in the field and enable the discovery of inhibitors of BAFF using Xencor's dominant negative strategy. The company is creating inhibitors of BAFF to treat autoimmune diseases such as lupus, multiple sclerosis and rheumatoid arthritis.

• YM BioSciences Inc., of Mississauga, Ontario, reported the publication of a research paper in the Jan. 15, 2004, issue of the Journal of Clinical Oncology regarding a Phase III trial of tesmilifene in breast cancer. Study results demonstrated a significant survival benefit for patients with metastatic breast cancer who were treated with tesmilifene. The study showed that tesmilifene, plus doxorubicin, was statistically superior to doxorubicin alone in terms of overall survival for women with metastatic or recurrent breast cancer (p=0.021). Specifically, the results showed that patients receiving a tesmilifene/doxorubicin combination therapy lived about 50 percent longer than those receiving doxorubicin alone, i.e., 23.6 months vs. 15.6 months. The FDA has granted YM clearance for a pivotal Phase III trial of tesmilifene in metastatic breast cancer.

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