• 4SC AG, of Martinsried, Germany, and Mutabilis SA, of Paris, signed a partnership to identify new molecules as a basis for drug discovery against an undisclosed target provided by Mutabilis. 4SC will use its virtual high-throughput screening technology, 4Scan, to screen a database of 4.6 million small organic molecules to identify active compounds that bind to the target. Mutabilis will get a selection of the best-ranked molecules for biological testing and evaluation. 4SC receives undisclosed research funding and is eligible for milestone payments.

• Affymetrix Inc., of Santa Clara, Calif., said its high-density GeneChip microarrays were used by Perlegen Sciences Inc., of Mountain View, Calif., for studies of the genetic causes of Alzheimer's disease, autism and Parkinson's disease. Perlegen, formed in late 2000 as a spin-off from Affymetrix, is using the microarrays to produce genotypes.

• Amgen Inc., of Thousand Oaks, Calif., said the European Commission approved expanded marketing authorization for Aranesp (darbepoetin alfa) in the European Union following the positive opinion from the European Committee for Medicinal Products for Human Use in July. The decision allows extended Aranesp dosing intervals of once every three weeks for anemia in adult cancer patients with non-myeloid malignancies who are receiving chemotherapy and up to once per month administration for anemia in chronic kidney disease patients not on dialysis. Aranesp was first granted European Union marketing authorization and FDA approval in 2001 for the treatment of anemia associated with chronic renal failure. Separately, Amgen partially funded a study that showed that about half of non-Hodgkin's lymphoma patients did not receive their full recommended dose and schedule of chemotherapy. Similar results were observed in a previous breast cancer study, pointing to a potential trend across different cancer types in reductions or delays in chemotherapy regimens largely driven by neutropenia. The findings were reported in the Journal of Clinical Oncology.

• Anadys Pharmaceuticals Inc., of San Diego, was awarded a Phase II Small Business Innovation Research grant from the National Institutes of Health in Bethesda, Md. It is expected to total $1.2 million over two years and is titled "Rational Design of Antibiotics Targeted at the Ribosome." It will fund Anadys' efforts to develop antibacterials that inhibit ribosomal function in drug-resistant bacteria.

• aRigen Inc., of Tokyo, began a Phase I study of WAP 8294A2, an antibiotic with antimicrobial efficacy against methicillin-resistant Staphylococcus aureus and other drug-resistant strains. The study is designed to provide information on the safety, tolerability and pharmacokinetic profile of the compound as an intravenous infusion. All rights for the product's future development have been assigned to privately held aRigen, which was formed to acquire and develop assets from Japanese pharmaceutical firms, public research institutes and universities.

• Astralis Ltd., of Fairfield, N.J., completed enrollment of all 120 patients required for its Phase II trial of Psoraxine. The study is evaluating the safety and efficacy of repeated administrations of Psoraxine for patients with moderate to severe plaque psoriasis. Patients participating in the study have been enrolled at 11 clinical sites throughout the U.S. The primary objective is to evaluate the safety and efficacy of multiple administrations of Psoraxine at three dose levels, compared to a placebo.

• BioDiscovery Inc., of El Segundo, Calif., released Version 2.7 of its GeneDirector software for enterprise microarray data management of spotted arrays and Affymetrix Inc. arrays. Separately, BioDiscovery reported at the Chips to Hits conference in Boston that it released ImaGene 6.0, which includes new image analysis and data analysis capabilities.

• Cambridge Research & Instrumentation Inc., of Woburn, Mass., released its CRI Maestro system, an in vivo system for fluorescence-based small-animal imaging. The company said its multi-spectral acquisition and analysis provides sensitivity, multilabel flexibility and quantitative accuracy for visible and near-infrared labels.

• Cell Signaling Technology Inc., of Beverly, Mass., entered an agreement with Sanofi-Aventis Group, of Paris, to perform a pilot study employing CST's PhosphoScan technology to identify phosphorylation sites and prospective biomarkers of protein tyrosine kinase targets. The phospho-proteomics technology combines immuno-affinity purification and mass spectroscopy to determine cellular PTK phosphorylation profiles called TKSignatures. Terms were not disclosed.

• Ceregene Inc., of San Diego, confirmed that the first patient was treated in a Phase I study of CERE-110, a gene-therapy product that involves in vivo delivery of nerve growth factor (NGF) genes through an adeno-associated viral vector delivery system. The naturally occurring NGF gene encodes the NGF protein that maintains survival of nerve cells in the brain that are required for memory and cognitive function, the company said.

• ConjuChem Inc., of Montreal, started dosing healthy volunteers in a Phase I multidose trial with its DAC:GRF compound for the treatment of growth hormone-deficiency in children and adults. The study will enroll a maximum of 30 subjects in up to five cohorts of six subjects each. Each subject will receive two or three subcutaneous doses of DAC:GRF or placebo. The primary endpoint is to assess the compound's safety and tolerability. Data are expected in the early part of 2005. DAC:GRF is a chemically modified form of growth hormone-releasing factor that covalently and permanently bonds to albumin, the dominant protein in blood.

• Curis Inc., of Cambridge, Mass., said the current online issue of Cancer Cell contains a report demonstrating that treatment with a small-molecule inhibitor of the Hedgehog signaling pathway, HhAntag, halted tumor growth and eliminated the tumor in a model of medulloblastoma at high doses. Curis discovered the compound in its research on the Hedgehog signaling pathway. The report is authored by researchers from the St. Jude Children's Research Hospital in Memphis, Tenn., and Curis. St. Jude researchers said the eradication of brain tumors in mice following the treatment suggest that certain cancers might one day be cured without the use of toxic chemotherapy and radiation.

• DNA 2.0 Inc., of Menlo Park, Calif., was awarded a Small Business Innovative Research grant by the National Human Genome Research Institute, a division of the National Institutes of Health in Bethesda, Md. The project goals are to increase the fidelity and reduce the cost of synthetic DNA manufacture.

• Draximage Inc., of Mississauga, Ontario, a subsidiary of Draxis Health Inc., received FDA approval to start a Phase II study of Infecton, a radiopharmaceutical molecular-imaging agent, for detecting and determining the location of a difficult-to-diagnose infection in the body. The study will examine patients with bacterial osteomyelitis, a chronic or acute infection of the bone. Two other Infecton trials are being conducted in Canada, one in diabetic patients with bacterial foot infections and the other in patients with known soft-tissue infections or chronic inflammatory conditions.

• Geospiza Inc., of Seattle, released FinchTV 1.2, a free, cross-platform trace-viewing software utility for use in DNA-sequencing analysis that incorporates sequence editing, insert and delete capabilities, selection and copying of bases for use in another application, as well as the ability to search for a given sequence.

• Gilead Sciences Inc., of Foster City, Calif., and the Biotechnology Institute in Arlington, Va., started an initiative called the Biotechnology Workforce Development and Community College Program. The goal is to promote employers' awareness that community colleges are producing graduates skilled for jobs in manufacturing and research and development, and to alert community colleges to the needs of biotech companies. The program will be piloted in California before being implemented across the U.S.

• Halozyme Therapeutics Inc., of San Diego, reiterated plans to file a new drug application in the first quarter of next year for Enhanze SC, despite the FDA's grant of marketing exclusivity to Vitrase (hyaluronidase, ISTA Pharmaceuticals Inc.). Enhanze SC is a formulation of recombinant human hyaluronidase manufactured as a purified enzyme preparation, Halozyme said, while Vitrase is a formulation of hyaluronidase extracted from ram testicles. Halozyme said its recombinant human hyaluronidase is a new molecular entity and is differentiated from bovine and ovine hyaluronidase products.

• Hydra Biosciences Inc., of Cambridge, Mass., signed a deal with Evotec OAI AG, of Hamburg, Germany, to advance the discovery of ion channel modulators. Evotec will provide Hydra biology and screening services to identify active compounds against an ion channel target being developed by Hydra. Evotec will produce reagents, develop assays, screen compounds and characterize hits generated by the program.

• ID Biomedical Corp., of Vancouver, British Columbia, was awarded up to $8 million from the National Institutes of Health in Bethesda, Md., to develop a nasally delivered plague vaccine based on the company's intranasal proteosome adjuvant/delivery technology. The primary aim of the work is to develop a subunit plague vaccine using a recombinant plague antigen, the FIV protein, formulated with the proteosome technology.

• Immuno-Designed Molecules SA, of Paris, received FDA approval to begin a clinical trial of Uvidem, its therapeutic vaccine for melanoma. The Phase II study will enroll 37 patients with Stage III or IV melanoma, whose disease is progressing with measurable or evaluable lesions. The product, developed in partnership with Sanofi-Aventis Group, also of Paris, consists of mature dendritic cells loaded with lysates of tumor cell lines.

• Inhibitex Inc., of Atlanta, said the FDA designated Aurexis a fast-track product. The humanized monoclonal antibody is being evaluated in a Phase II trial for the first-line treatment of serious hospital-associated Staphylococcus aureus bloodstream infections. The company expects to report data in the first half of next year, and in the future plans to explore the use of Aurexis in other indications such as S. aureus infections in end-stage renal disease and cystic fibrosis patients. Inhibitex's stock (NASDAQ:INHX) gained $1.27 Tuesday, or 24.6 percent, to close at $6.42.

• Introgen Therapeutics Inc., of Austin, Texas, said the National Cancer Institute in Bethesda, Md., awarded it a $700,000 grant to evaluate the anti-angiogenic properties of mda-7/IL-24. The mda-7 gene is the active component of the company's INGN 241 cancer therapy. The research is to be performed over a three-year period by one of Introgen's academic collaborators.

• Inyx Inc., of New York, completed the acquisition of a platform technology designed to enable the company to develop inhalation therapy drugs, including combination drugs, delivered in aerosol formats. Financial terms were not disclosed. Inyx acquired the technology from Phares Technology BV, the parent company of Phares Drug Delivery AG, of Muttenz, Switzerland. Phares will provide related product development and technology support.

• Ista Pharmaceuticals Inc., of Irvine, Calif., said the FDA granted the company three years of market exclusivity for Vitrase (hyaluronidase for injection) for use as a spreading agent to facilitate the dispersion and absorption of other drugs. Vitrase is a formulation of highly purified ovine hyaluronidase that was approved by the FDA in May. Ista filed a supplemental new drug application in August for a smaller, single-use vial of Vitrase. If approved, the new vial size could be launched in early 2005. (See BioWorld Today, May 7, 2004.)

• Kereos Inc., of St. Louis, and The Dow Chemical Co., of Midland, Mich., entered a licensing agreement to allow both companies access to patent portfolios for the development and commercialization of targeted imaging agents. The agreement is intended to facilitate development and marketing of targeted imaging agents for more accurate diagnosis of cancer and cardiovascular disease. The companies formed a collaboration in April 2003 under a National Cancer Institute contract. Financial terms were not disclosed.

• Medinox Inc., of San Diego, said researchers at the Children's Hospital of Philadelphia published findings in the June issue of the British Journal of Haematology showing that the company's MX-1520 prodrug, a form of vanillin, might be a viable candidate to treat sickle cell disease. After specially bred mice received MX-1520, they survived five times longer than mice that did not receive the chemical. Once MX-1520 enters the bloodstream, the company said, it turns into vanillin and binds with sickle hemoglobin and prevents the formation of sickled cells.

• Migenix Inc., of Vancouver, British Columbia, (formerly Micrologix Biotech Inc.) began trading on the Toronto Stock Exchange under the symbol "MGI" on Tuesday. The change in trading symbol reflects the name change that was effective Sept. 9. Trading on the U.S. Over-the-Counter Bulletin Board will be under the symbol "MGIFF," formerly "MGIXF." Migenix is a developer of drugs for infectious and degenerative diseases.

• Nymox Pharmaceutical Corp., of Maywood, N.J., reported Phase II results showing that the use of NX-1207 produced a statistically significant symptomatic improvement in individuals with benign prostatic hyperplasia, both at 30 days and after one year of follow-up. Those followed-up after a year showed an 8.8-point improvement compared to controls, exceeding the 6.9-point improvement found after 30 days. There also was shrinkage in prostate size in the 20-patient study.

• Pharmion Corp., of Boulder, Colo., said the Agency for the Evaluation of Medicinal Products accepted for review the company's marketing authorization application for Vidaza for the treatment of myelodysplastic syndromes. Vidaza was granted orphan product designation by the EMEA. Vidaza is the first drug approved in the U.S. for MDS, and it was approved for all five subtypes of MDS on May 19. (See BioWorld Today, May 21, 2004.)

• Telik Inc., of Palo Alto, Calif., said its Target-Related Affinity Profiling drug discovery technology was used to identify small-molecule lead compounds using the "affinity fingerprints" of approved drugs with known activity against a selected biological target. The study resulted in the identification of biologically active molecules that were structurally distinct from known compounds, providing an advantage over methods that rely on chemical structure alone for modeling bioactivity, Telik said. The study was published in the Journal of Medicinal Chemistry.

• Wilex AG, of Munich, Germany, started a Phase I trial of WX-671, an oral non-cytotoxic cancer compound. The study will evaluate the oral bioavailability, pharmacokinetics and safety of the drug in 12 male volunteers. WX-671 is a second-generation serine protease inhibitor that targets the urokinase plasminogen-activator system, which has been shown to play a role in metastasis and solid-tumor growth.

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