• Abgenix Inc., of Fremont, Calif., began a Phase I trial of ABX-PTH, a fully human monoclonal antibody being developed for secondary hyperparathyroidism. The trial follows acceptance of an investgational new drug application by the FDA. The product, generated by Abgenix's technology platform, is designed to target and neutralize the action of parathyroid hormone.

• Agilent Technologies Inc., of Palo Alto, Calif., launched its whole-human genome microarray compatible with major standard 1 inch by 3 inch microarray scanners. The product is designed for scientists researching disease and developing therapeutic interventions in areas such as cancer and cardiovascular disease.

• Allos Therapeutics Inc., of Westminster, Colo., said the FDA would conduct a priority review of its new drug application for RSR13 (efaproxiral) as an adjunct to whole-brain radiation therapy for brain metastases in breast cancer patients. As a result, the agency will take action on the filing within six months from the submission date, or by June. The company completed its rolling submission in December under the FDA's fast-track designation. Allos' stock (NASDAQ:ALTH) gained 29 cents Tuesday to close at $3.80. (See BioWorld Today, Nov. 18, 2003.)

• Baxter Healthcare Corp., of Deerfield, Ill., is sponsoring the first clinical study of adult stem cell reimplantation in the heart to determine the benefit of using adult stem cells to treat coronary artery disease. The new procedure involves collecting stem cells from a patient's blood, and then using a catheter-based system to inject the cells into heart muscle where they may help to grow new blood vessels. A team of physicians at Caritas St. Elizabeth's Medical Center in Boston performed the first procedure on a 75-year-old man, the first of 24 patients to be included in the randomized, double-blinded Phase I study scheduled for completion in about nine months.

• Beyond Genomics Inc., of Waltham, Mass., entered a pilot agreement to apply its Systems Biology know-how to predictive toxicology in an arrangement with AstraZeneca plc, of London. Beyond Genomics will use its Systems Biology platforms and BioSystematics informatics tools to analyze and integrate transcript, protein and metabolite data in a study designed to discover biomarkers of drug-induced toxicity. Financial terms were not disclosed.

• BioDiscovery Inc., of El Segundo, Calif., said its GeneDirector enterprise microarray data management software solution was being used by ArraGen Ltd., of Craigavon, Northern Ireland, as its primary tool for managing data generated as part of its development of microarray-based diagnostics for the cancer market.

• Biogen Idec Inc., of Cambridge, Mass., and Elan Corp. plc, of Dublin, Ireland, filed an investigational new drug application with the FDA for Antegren (natalizumab) to treat rheumatoid arthritis. The companies expect to begin a Phase II trial in the first half of this year. The study will be a multicenter, double blind, placebo-controlled trial of the efficacy, safety and tolerability of intravenous Antegren in RA patients receiving treatment with methotrexate.

• BioMicro Systems Inc., of Salt Lake City, launched the Maui Mixer DC, a dual hybridization chamber designed to allow two independent arrays to be processed simultaneously on a single standard glass slide. The Mixer DC is the latest addition to a line of disposable, mixing micro-chamber products used with the company's Maui Hybridization System.

• Caliper Life Sciences Inc., of Hopkinton, Mass., released its LabChip 3000 Drug Discovery System at the LabAutomation 2004 conference in San Jose, Calif. The product, the latest addition to the company's suite of LabChip Microfluidic Systems, performs unattended biochemical and cell-based screening assays using Caliper's microfluidic chips.

• Celsion Corp., of Columbia, Md., said the FDA signed off on two amendments to its Phase I dose-escalation study of ThermoDox, a liposome-encapsulated formulation of doxorubicin for prostate cancer. The original Phase I protocol was limited to patients whose cancer had spread beyond the prostate, but the agency is allowing the inclusion of patients with progressive prostate cancer in situ. Also, the FDA permitted the company to add an additional site in Myrtle Beach, S.C.

• Chromos Molecular Systems Inc., of Burnaby, British Columbia, and AviGenics Inc., of Athens, Ga., formed an agreement under which AviGenics has acquired exclusive rights to Chromos' ACE System to generate transgenic avians to develop protein therapeutics and other applications in the avian transgenic field. AviGenics will combine the ACE System with its transgenic platform to develop new protein therapeutics. Chromos will receive up-front and annual license fees, milestone payments, as well as potential royalties.

• DiaDexus Inc., of South San Francisco, said a prospective, case cohort study of the Atherosclerosis Risk in Communities population was published in the online edition of Circulation by researchers at Baylor College of Medicine and Methodist DeBakey Heart Center, both in Houston. The company said their findings support the measurement of lipoprotein-associated phospholipase A2 (Lp-PLA2) to help identify individuals at risk for coronary heart disease. The research team examined the relationship between Lp-PLA2, C-reactive protein, traditional risk factors and the risk for a coronary heart disease event over the course of six to eight years stratified by low-density lipoprotein cholesterol. Results show mean levels of Lp-PLA2 and CRP were higher in the 608 men and women who developed such events than a matched group of 740 individuals who remained free of disease, after adjustment for age, sex and race.

• Forbes Medi-Tech Inc., of Vancouver, British Columbia, said it completed a Phase II trial of its cholesterol-lowering agent, FM-VP4. The trial is measuring the drug's efficacy and safety at the Academic Medical Center in Amsterdam, the Netherlands, a center for the research of dyslipidaemia. The company expects data to be available toward the end of this quarter. The trial consisted of four groups of 25 hypercholesterolemic volunteers treated daily for 28 days with either placebo or FM-VP4.

• Genome Therapeutics Corp., of Waltham, Mass., said its registration statement relating to the sale of up to 16.8 million common shares at $5.25 apiece was declared effective by the SEC. The company might ultimately sell less than all of those shares. J.P. Morgan Securities Inc. is the offering's lead placement agent, with Legg Mason Wood Walker Inc. as co-placement agent. The transaction is expected to close Friday. Genome Therapeutics' stock (NASDAQ:GENE) gained 67 cents Tuesday, or 11.7 percent, to close at $6.38.

• GPC Biotech AG, of Martinsried, Germany, expanded its multinational Phase III registration trial of satraplatin to include Europe after receiving guidance from European regulatory authorities. The company is proceeding with the SPARC (Satraplatin and Prednisone Against Refractory Cancer) trial, which is evaluating satraplatin plus prednisone vs. placebo plus prednisone as a second-line chemotherapy regimen for treating patients with hormone-refractory prostate cancer. In September, SPARC began in the U.S., where the drug has been granted fast-track designation. GPC's co-development partner is Spectrum Pharmaceuticals Inc., of Irvine, Calif. (See BioWorld Today, Sept. 30, 2003.)

• Hyalozyme Therapeutics Inc., of San Diego, completed a $9.2 million financing led by Grove Capital. The financing also included an option to purchase an additional $15.9 million in warrants callable by Hyalozyme, which is developing recombinant human enzymes for infertility, ophthalmology and oncology.

• Insightful Corp., of Seattle, paid $2 million to acquire the copyrights to the software code underlying the "S" language from Lucent Technologies Inc., of Murray Hill, N.J. The S language is the foundation of S-PLUS, the company's flagship product for statistical data analysis. Insightful provides software solutions for analysis of numeric and text data.

• Integrated BioPharma Inc., of Hillside, N.J., said scientists at its NuCycle Therapy subsidiary teamed with Purdue University researchers in a two-year study to transfer genes involved in the metabolism of selenium into edible plants. The study, funded by the National Institutes of Health in Bethesda, Md., has shown that the transgenic plants created became more selenium tolerant and converted the selenium into methylselenocysteine, which reduces the incidence of breast and colon cancer in animal studies.

• Isolagen Inc., of Houston, said results of a six-month, double-blind study showed that its treatment successfully reversed gingival recession and improved deep periodontal pocketing. Clinical examinations were conducted in 176 intra-oral sites in 21 subjects. A paired T test demonstrated that Isolagen response exceeded placebo response by an average of 1.1 mm (p=0.0005). Also, 81 percent showed an improvement in pocket depth in Isolagen-treated areas, while only 33 percent showed improvement in placebo-treated areas.

• Labopharm Inc., of Laval, Quebec, disclosed plans to formulate a once-daily version of the anti-depressant trazodone hydrochloride for global commercialization after signing an agreement with Gruppo Angelini in Italy. Originally developed by Angelini, trazodone is marketed globally only in immediate-release formulations. In the U.S., it is marketed as Desyrel by Bristol-Myers Squibb Co., of New York. Labopharm granted Angelini the exclusive right to market and sell the once-daily formulation of the analgesic tramadol in Italy.

• Micrologix Biotech Inc., of Vancouver, British Columbia, acquired the global rights to a Phase I/II compound for chronic hepatitis C virus called celgosivir from Virogen Ltd., of London. Celgosivir, to be designated MBI-3253, has been evaluated in more than 600 subjects to date. Micrologix, which said it intends to begin Phase II development of the oral antiviral agent this year, will pay an up-front fee in equity to Virogen and will pay milestone payments in cash and/or equity upon the achievement of agreed-upon development objectives, as well as royalties on product sales and sublicensing revenues. More specific financial terms were not disclosed.

• MycoLogics Inc., of Aurora, Colo., was awarded a Phase I Small Business Innovation Research grant from the Department of Health and Human Services to derive a vaccine against San Joaquin Valley Fever (Coccidioidomycosis). The company labeled the emerging fungal disease, which is caused by Coccidioides immitis, as endemic in portions of California, Arizona, New Mexico and Texas. MycoLogics is using a vaccine delivery system designed to accommodate potential cocktails, with collaboration from the California Institute for Medical Research.

• Nektar Therapeutics, of San Carlos, Calif., disclosed the existence of a collaboration under which it has licensed a PEG (PEGylation) reagent used in the manufacture of CERA (Continuous Erythropoiesis Receptor Activator), a product from F. Hoffmann-La Roche Ltd., of Basel, Switzerland. Under the three-year old collaboration, Nektar receives milestone and manufacturing revenues during development and will receive royalty and manufacturing revenues upon successful commercialization of the product.

• Neurobiological Technologies Inc., of Richmond, Calif., received a $2.25 million payment from Merz Pharmaceuticals GmbH, of Frankfurt, Germany, following FDA approval of Namenda (memantine) to treat moderate to severe Alzheimer's disease. Forest Laboratories Inc., of New York, markets Namenda, which was approved in October 2003, in the U.S. (See BioWorld Today, Oct. 20, 2003.)

• OpGen Inc., of Madison, Wis., completed a whole genome map of the fungal pathogen Aspergillus fumigatus (strain Af293) for an international project aimed at determining the complete genome sequence of the organism. The global sequencing consortium generated more than 28 million bases of sequence data in 19 individual contiguous sequences. OpGen said its data allowed all 19 to be ordered and orientated on the eight chromosomes identified by the whole genome optical map, establishing the number, location and size of the gaps remaining to be finished.

• Pharmacopeia Inc., of Princeton, N.J., entered a research collaboration with Altana Pharma AG, of Konstanz, Germany, under which both parties will work together to identify and optimize small-molecule lead compounds in an undisclosed indication. Pharmacopeia will provide its small-molecule discovery assets, including its multimillion-compound collection of drug-like small molecules and modeling and design capabilities, to identify and optimize leads in a key therapeutic area for Altana. In return, Pharmacopeia will receive funding for its research services and will be entitled to receive additional payments upon the successful achievement of milestones, as well as royalties upon the commercialization of any resulting drugs.

• PPD Inc., of Wilmington, N.C., made a $5 million equity investment in Accentia Inc., of Tampa, Fla., through a purchase of Series E convertible preferred stock. In addition to the customary terms associated with such investments, Accentia's Series E shares will pay a dividend based on a percentage of net sales of certain Accentia products. Accentia is developing targeted therapeutics through drug delivery technologies for the respiratory, oncology and critical care areas.

• Raven Biotechnologies inc., of South San Francisco, entered a research collaboration with Abbott Laboratories, of Abbott Park, Ill., to evaluate a panel of privately held Raven's monoclonal antibodies and their corresponding targets for therapeutic and diagnostic applications. Financial terms and other details were not disclosed.

• Ribonomics Inc., of Durham, N.C., was awarded $150,000 by the North Carolina Biotechnology Center in recognition of the high commercial potential and scientific merit of the company's functional clustering technology. The funds will be used to complete commercial development of the Ribonomics Analysis System (RAS), a technology that allows the physical isolation and characterization of functionally related genes in vitro and in vivo.

• Senesco Technologies Inc., of New Brunswick, N.J., raised net proceeds of about $2.5 million after completing a private placement of about 1 million units at $2.37 apiece with institutional and other accredited investors. Each unit was composed of one share of newly issued common stock and a warrant to purchase 0.35 of a share at an exercise price of $3.79 each. Senesco has developed technology that regulates the onset of cell death.

• Xcel Pharmaceuticals Inc., of San Diego, acquired exclusive worldwide rights to retigabine, a late-stage candidate for epilepsy, from Viatris GmbH and Co., of Frankfurt, Germany. Xcel will have complete responsibility for the product, including worldwide clinical development, regulatory approval and commercialization. Xcel intends to hold an end-of-Phase II meeting with the FDA later this year, and plans to begin a pivotal Phase III program next year. With its focus in the U.S., Xcel plans to seek partners to co-develop and commercialize retigabine for the rest of the world. Financial terms were not disclosed.

• Xechem International Inc., of New Brunswick, N.J., applied for orphan drug status for Myodur, which demonstrated safety and efficacy in preclinical trials for muscular dystrophy. The lead product acquired through the company's purchase of Ceptor Inc., of Stony Brook, N.Y., Myodur includes carnitine, a membrane-transport carrier molecule that targets skeletal muscle, and its passenger molecule, leupeptin, a known calpain inhibitor. Because calpain is up-regulated in muscular dystrophy, Xechem said leupeptin's inhibiting effect along with carnitine's targeting effect makes Myodur a candidate for the disease.