• Acacia Research Corp., of Newport Beach, Calif., said its CombiMatrix Group received a $5.9 million, two-year contract from the Department of Defense to further develop its microarray technology for the detection of biological threat agents. The focus of the contracts will be the integration of CombiMatrix's biotechnology with microelectronics and microfluidics and the development of an automated system for biothreat agents with reduced size and cost.

• Alexion Pharmaceuticals Inc., of Cheshire, Conn., said results of a meta-analysis reported at the American College of Cardiology meeting in New Orleans showed that the investigational drug pexelizumab significantly reduced 30-day mortality across multiple acute cardiovascular disease trials. In the studies, which enrolled coronary artery bypass graft patients and acute myocardial infarction patients, pexelizumab treatment was associated with a statistically significant 31 percent relative reduction in mortality when compared to placebo across the four trials (2.9 percent vs. 4.2 percent, p=0.017). The trials were conducted by Alexion and its partner Procter & Gamble Pharmaceuticals, an affiliate of Procter & Gamble Co., of Cincinnati.

• Allos Therapeutics Inc., of Westminster, Colo., filed a $75 million mixed shelf registration with the SEC. When declared effective, the shelf would allow the company to raise up to that amount through the sale of various securities in one or more future offerings.

• Amersham Biosciences, the life sciences business of Amersham plc, of London, launched the AKTAxpress protein purification system at the Pittcon 2004 meeting in Chicago. The company said the product delivers automated, high-throughput, multistep purification of His- and GST-tagged proteins.

• Amicus Therapeutics Inc., of New Brunswick, N.J., said the FDA granted orphan drug status for its first clinical candidate, AT1001, for the treatment of Fabry's disease. The company, which is developing therapies for human genetic disorders, said it is pleased with the progress of its small-molecule drug through preclinical development. AT1001 is designed to provide an oral therapy to enhance a patient's alpha-galactosidase A activity.

• Array BioPharma Inc., of Boulder, Colo., said it would begin clinical studies of ARRY-142886 (AZD6244) in cancer patients after the FDA approved its investigational new drug application. The small-molecule anticancer compound interferes with MEK, one step in a cellular hyperproliferation pathway in human cancer cells. Oral administration of ARRY-142866 in certain tumor models resulted in tumor suppression and regression, the company said.

• Beta-02, which is planning to establish offices in Kiryat Ariyeh, Petach-Tivka, Israel, completed a $2 million seed financing round. Vitalife, an Israeli life sciences venture capital fund, led the round in which Heznek, the seed fund of the government of Israel, also participated. It is the first joint investment of Vitalife and Heznek. Beta-02 develops technology to supply oxygen to transplanted cells, and its first application will be to supply oxygen to islet cells.

• Biocompare Inc., of South San Francisco, launched the Mass Spectrometry and Chromatography Center (MSCC) as part of Biocompare.com. The MSCC was created to give scientists a single website where they can learn about and compare mass spectrometry and chromatography products.

• Bruker BioSciences Corp., of Billerica, Mass., said its Bruker AXS Inc. subsidiary released several new products at the Pittcon 2004 meeting in Chicago. Among them were SuperSpeedSolutions, a new series of X-ray diffraction systems for materials research applications; the APEX II, a 4K CCD detector for measuring crystal structures of inorganic and organic chemistry compounds; and the Crystal Farm imaging system, an expanded set of integrated tools to produce protein crystal structures at an accelerated pace.

• Celltech Group plc, of Slough, UK, said a study published in this month's online issue of Pediatrics showed that once-daily Metadate CD (methylphenidate HCI) extended-release capsules was more effective than Concerta (methylphenidate HCl, Johnson & Johnson) during the morning hours when given to children with attention deficit hyperactivity disorder during the school day. The study, which compared the effects of the two extended-release methylphenidate formulations, showed that the treatments were similar in efficacy during the afternoon.

• Chiral Quest Inc., of State College, Pa., named privately held Strem Chemicals Inc., of Newburyport, Mass., a distributor for several of its chiral ligand products through Strem's marketing and distribution channels. The Chiral Quest ligands include Binaphane, C3-TunePhos, TangPhos and Binapine.

• Cytomedix Inc., of Little Rock, Ark., received FDA approval to begin clinical trials of its AutoloGel System for the treatment of chronic diabetic foot ulcers. The randomized, double-blind, controlled trial, which will enroll about 74 patients as a comparison against the standard of care for chronic wounds, is expected to begin in mid-April. The AutoloGel System involves the production of a treating composition that delivers multiple growth factors to the affected wound bed.

• First Horizon Pharmaceutical Corp., of Alpharetta, Ga., priced its private offering of $125 million principal amount of 1.75 percent senior subordinated contingent convertible notes due 2024. The company also granted initial purchasers an option to purchase up to an additional $25 million of such notes. The specialty pharmaceutical company, which markets prescription products with a focus on cardiology, women's health and pediatrics, said it would use the funds for future acquisitions of products, technologies and businesses and for general corporate purposes.

• Genaera Corp., of Plymouth Meeting, Pa., and the Ludwig Institute for Cancer Research in Hilden, Germany, extended by two years their collaboration for the joint discovery and development of genes and proteins as pharmaceutical targets and therapeutics, including further research related to interleukin-9. Genaera has developed IL-9, IL-9 receptor intellectual property and exclusively in-licensed related intellectual property from the institute, including the original patents to IL-9 and its receptor.

• Generex Biotechnology Corp., of Toronto, said results of a study published in Diabetes Technology & Therapeutics, co-authored by one of its officers, showed that the company's oral insulin spray formulation, Oralin, can be used as meal insulin as an add-on therapy in combination with failing oral, hypoglycemic agent treatment in Type II diabetics to regulate postprandial glucose levels. Generex funded the open-label, crossover, randomized study.

• Incyte Corp., of Wilmington, Del., issued an additional $50 million of its 3.5 percent convertible subordinated notes due 2011 after the initial purchasers exercised their option. With the exercise, Incyte sold $250 million worth of notes in a private placement to qualified institutional buyers. (See BioWorld Today, Feb. 17, 2004.)

• Inhibitex Inc., of Atlanta, began enrollment in a Phase II trial of Aurexis, a humanized monoclonal antibody being developed as a first-line therapy, in combination with standard of care antibiotics, for S. aureus bloodstream infections in hospitalized patients. The randomized, double-blinded, placebo-controlled trial, which will involve up to 60 patients, is designed to evaluate the safety, pharmacokinetics and preliminary efficacy of Aurexis.

• Interleukin Genetics Inc., of Waltham, Mass., said findings reported at the American College of Cardiology meeting in New Orleans showed that pro-inflammatory variants of the interleukin-1 gene cluster are associated with increased risk for early coronary heart disease. The variants previously have been shown to be associated with elevated levels of C-reactive protein, an inflammatory biomarker. Also, individuals with normal cholesterol levels (less than 200 mg/dL) who had a specific IL-1 gene variation had about four times the risk of early heart disease than those who did not have the gene variation, and the relative risk was greater among African-Americans. The data stem from a study conducted by the company using a subset of the Atherosclerosis Risk in Communities database, culled from a 15-year prospective study.

• La Jolla Pharmaceutical Co., of San Diego, said the underwriter of its recently completed public offering of stock purchased about an additional 1.3M shares at the offering price through the overallotment option. Net proceeds to the company, including proceeds from the overallotment, were about $29.5 million. Pacific Growth Equities LLC, of San Francisco, served as sole underwriter for the transaction. La Jolla is focused on developing therapeutics for antibody-mediated autoimmune diseases. (See BioWorld Today, Feb. 23, 2004.)

• Marshall Edwards Inc., of Washington, began a study to test the ability of its investigational anticancer drug, phenoxodiol, to enhance the effect of platinum drugs in patients with solid cancers, particularly late-stage renal carcinoma. The study patients have late-stage cancers that are no longer responding to standard chemotherapies, including platinum drugs such as cisplatin and carboplatin.

• Medinox Inc., of San Diego, said Phase I/IIa data reported at the World Congress on Trauma, Inflammation, Shock and Sepsis in Munich, Germany, demonstrated hemodynamic response rates after 48 hours for the 53 evaluable patients who received either NOX-100, a nitric oxide neutralizer, or placebo. For patients who received 1 mg of NOX-100, the rate was 29 percent; 3 mg produced a 79 percent rate; 6 mg produced a 70 percent rate; and 12 mg produced a 63 percent rate. Placebo patients had a 50 percent hemodymanic response rate. In the same patients, the rate of survival at 30 days for the NOX-100 groups were: 71 percent for 1 mg; 57 percent for 3 mg; 50 percent for 6 mg; and 63 percent for 12 mg. The 30-day survival rate in placebo patients was 43 percent.

• Microscience Ltd., of London, said clinical results demonstrated the safety and immunogenicity of its new oral vaccine, which is intended to protect against the infectious enterotoxigenic E. coli disease, the most common cause of travelers' diarrhea. The dose-escalating, open-label study showed that after a single dose, 50 percent of the volunteers mounted high levels of immune responses against a known protective antigen of the disease. After two doses, the response rate rose to 70 percent.

• Molecular Probes Inc., of Eugene, Ore., released two products designed to improve the quality of fluorescence images. Its Image-iT FX product increases the signal-to-noise ratio in tissues and cells visualized through immuno-fluorescence techniques. Its Prolong Gold antifade reagent increases the stability of fluorescent signals, extending the time available for imaging.

• MorphoSys AG, of Munich, Germany, said it would generate antibodies against a target molecule involved in autoimmune diseases selected by its partner, Centocor Inc., a unit of Johnson & Johnson, of New Brunswick, N.J. MorphoSys will use its HuCAL Gold technology within the scope of its collaboration with Centocor, which will carry out preclinical and clinical development and subsequent marketing of resulting products. MorphoSys stands to receive licensing and milestone payments, in addition to royalties, though more specific financial terms were not disclosed. The agreement dates back more than three years. (See BioWorld Today, Jan. 4, 2001.)

• MWG Biotech AG, of Ebersberg, Germany, undertook the sequencing work as part of a project in which the whole genome of Saccharopolyspora erythraea was sequenced by Aventis Bulk SpA, the Italian affiliate of Aventis SA, of Strasbourg, France. The complete genomic sequence will form the basis for new approaches in strain development methodologies, and the whole sequence is the property of Aventis Bulk.

• NeoPharm Inc., of Lake Forest, Ill., began enrolling patients in PRECISE, the pivotal Phase III trial of IL13-PE38QQR, its experimental tumor-targeting, anticancer drug for recurrent glioblastoma multiforme. The product has received orphan drug designation in Europe and the U.S. and fast-track drug development program status from the FDA. NeoPharm's IL13-PE38QQR development program also was selected to participate in the agency's new Continuous Marketing Application Pilot 2 Program. (See BioWorld Today, Feb. 9, 2004.)

• Nuvelo Inc., of Sunnyvale, Calif., completed its public offering of 5 million common shares and the additional sale of 750,000 shares pursuant to the exercise of an overallotment option granted to the underwriters. Including the additional sale, the company sold 5.75 million shares at $13 apiece, resulting in gross proceeds of about $74.8 million. (See BioWorld Today, March 4, 2004.)

• Pain Therapeutics Inc., of South San Francisco, said it enrolled more than 350 patients in its first Phase III study of Oxytrex, remaining on track with the oral painkiller's development. With the study about half enrolled, the company said its next milestone would be the beginning of a second Phase III Oxytrex study later this month. It will evaluate about 700 severe osteoarthritic pain patients; the first is studying the drug in patients with severe lower back pain.

• Pharmion Corp., of Boulder, Colo., said all of its outstanding $14 million of convertible notes due in 2008 have been converted into common stock. The conversion results in a reduction of $14 million of debt and increases the company's common shares outstanding by 1.3 million shares, or about 5 percent. Pharmion, which had the right to call the notes if its shares traded with an average $15 closing price for 20 consecutive trading days, issued the 6 percent notes last April.

• Threshold Pharmaceuticals Inc., of South San Francisco, began a Phase I trial of 2-deoxy-D-glucose (2-DG), one of a class of compounds that selectively target the slow-growing but highly metastatic cells within the poorly vascularized zones of solid tumors. The study's objective is to evaluate the drug's safety, pharmacokinetics and pharmacodynamics in humans and to determine the maximum tolerable dose. It will evaluate daily oral doses of 2-DG with and without weekly doses of Taxotere (docetaxel, Aventis SA) in up to 30 adult subjects with previously treated, advanced solid malignancies. The trial will be carried out at the University of Miami's Sylvester Comprehensive Cancer Center.

• Tularik Inc., of South San Francisco, said Sankyo Co. Ltd., of Tokyo, expanded their collaboration to jointly discover and develop human therapeutics that act on G protein-coupled receptors (GPCRs). Sankyo selected up to four GPCR targets for further research for one year, resulting in additional financial support to Tularik. In December, Sankyo selected a separate GPCR target for further research under the collaboration for up to four years. The parties will share equally all clinical development costs and profits from resulting compounds in the U.S. and Europe, and Tularik is entitled to milestone and royalty payments if compounds progress through clinical trials to registration outside of the U.S. and Europe. Other financial terms were not disclosed.

• Vaso Active Pharmaceuticals Inc., of Danvers, Mass., said a stock split, effective in the form of a 200 percent stock dividend, was executed as of Friday's close of trading. Holders of the company's Class A or Class B stock will receive a dividend of two shares of Class A or Class B common stock for every one share of Class A or Class B stock held as of that date. The company expects that the combined amount of issued and outstanding shares of both the Class A and B stock after the split would be increased from about 3.4 million shares to about 10.3 million shares.

• Vion Pharmaceuticals Inc., of New Haven, Conn., said it received fast-track designation from the FDA for cloretazine in relapsed or refractory acute myeloid leukemia. Cloretazine is a sulfonyl hydrazine DNA alkylating agent.

• Viragen Inc., of Plantation, Fla., extended its agreement to develop avian transgenic technology with the Roslin Institute in Edinburgh, Scotland. The agreement, extended by two years, continues to provide Viragen with worldwide exclusive rights to commercialize avian transgenic biomanufacturing technology, which is designed to substitute chicken eggs for expensive bioreactor vessels presently used in the manufacture of protein-based drugs.