• Adventrx Pharmaceuticals Inc., of San Diego, began dosing patients in a first-line Phase II trial of CoFactor for metastatic colorectal cancer. CoFactor, a biomodulator of 5-fluorouracil (5-FU), will be evaluated in patients not previously treated or in those who have relapsed from previous 5-FU/leucovorin therapy. CoFactor is designed for use with 5-FU, and it qualifies for the FDA's fast-track program for rapid drug review for metastatic colorectal cancer.

• The American Stock Exchange in New York began trading in options on Indevus Pharmaceuticals Inc., of Lexington, Mass.; Vicuron Pharmaceuticals Inc., of King of Prussia, Pa.; and Pharmion Corp., of Boulder, Colo.

• Atrix Laboratories Inc., of Fort Collins, Colo., said that Eligard 7.5 mg and 22.5 mg (one- and three-month sustained release) injections were launched Tuesday in Germany by Yamanouchi Pharmaceutical Co. Ltd., of Tokyo. Eligard is indicated for the palliative treatment of advanced prostate cancer. It was approved in these two doses in December and January, respectively. Atrix and MediGene AG, of Martinsried, Germany, which licensed marketing rights to the Eligard products from Atrix in April 2001, signed a pan-European marketing agreement with Yamanouchi earlier this year.

• AVI BioPharma Inc., of Portland, Ore., said data from a Phase I/II trial of AVI-4020 showed presence of the drug in cerebrospinal fluid of West Nile virus patients treated with the Neugene antisense drug. The company said such results represent the first report of an antisense drug crossing the blood-brain barrier in a clinical study, which involved 10 patients, nine of whom received AVI-4020 and one who received placebo. Pharmacokinetic data showed that the plasma elimination half-life of the third-generation antisense drug was four to five hours.

• BioCurex Inc., of Richmond, British Columbia, said results of an independent evaluation of its Histo-Recaf-based cancer-detection system showed that it detected 82.6 percent of cancers with a specificity of 95.5 percent. The Japanese study included 23 stomach cancer and 22 normal tissue samples.

• BioLineRx Ltd., of Jerusalem, said it has raised $15 million in initial capital from a group of founding investors, which includes Star Ventures, Yehuda Zisapel, Teva Pharmaceuticals Ltd., Pitango Venture Capital, Giza Venture Capital, Hadasit, a subsidiary of Hadassah Medical Center, and the Jerusalem Development Authority. Founded last year, BioLineRx is working to advance programs from early stage discovery and lead generation to advanced clinical trials, regulatory approval and marketing through partnerships with researchers, universities and biotech companies.

• Cel-Sci Corp., of Vienna, Va., raised gross proceeds of $5.25 million after completing an offering of about 6.4 million registered common shares at 82 cents apiece. The company, which offered the stock pursuant to an existing shelf registration statement, expects to use proceeds primarily to advance the clinical development of Multikine, its lead immunotherapy product for cancer. Wachovia Capital Markets LLC acted as the offering's placement agent.

• Curis Inc., of Cambridge, Mass., said studies published in a recent issue of the Journal of Molecular Medicine showed that administration of BMP-7 reversed the effects of a certain cause of kidney scarring or fibrosis, thereby promoting restoration of kidney function. Previous research has shown that BMP-7, a compound normally made in the kidney, can promote restoration of kidney function in certain preclinical models of chronic kidney disease by antagonizing the effects of epithelial to mesenchymal-mediated kidney fibrosis. In the current study, the authors note that such antagonism results in the repair of injured kidneys, suggesting that modulation of epithelial cell plasticity has therapeutic advantages.

• Cytokinetics Inc., of South San Francisco, closed its initial public offering of about 7.9 million common shares at $13 apiece, which includes the full exercise of the underwriters' option to purchase about 1 million more shares for total gross proceeds of about $103.2 million. The company said its net proceeds are about $95.9 million. Goldman, Sachs & Co. acted as bookrunner and lead manager, and Credit Suisse First Boston, Pacific Growth Equities LLC and Lazard Freres & Co. acted as co-managers. (See BioWorld Today, April 30, 2004.)

• DUSA Pharmaceuticals Inc., of Wilmington, Mass., said its registration statement in connection with a recent private placement was declared effective. The transaction relates to the nearly 2.6 million shares issued to investors and the 155,250 shares issued to the placement agent. DUSA, which is developing photodynamic therapy products, said the action allows the resale of its shares by certain selling shareholders from time to time, and it would not receive any proceeds from such resale.

• Epoch Biosciences Inc., of Bothell, Wash., entered a collaboration with a national reference laboratory called Associated Regional and University Pathologists Inc., of Salt Lake City, for the development and supply of Epoch's MGB Eclipse Detection Reagents.

• Eyetech Pharmaceuticals Inc., of New York, and Pfizer Inc., also of New York, said a Phase II study of Macugen showed positive visual and anatomical outcomes for diabetic macular edema (DME). In the Macugen 0.3-mg group, 73 percent of patients gained 0 or more lines compared to 51 percent in the sham-injected group, a 43 percent relative treatment effect (p=0.02). Also, 59 percent of Macugen patients gained 1 or more lines compared to 34 percent in the sham-injected group, a 73 percent relative treatment effect (p=0.01); 34 percent of Macugen patients gained 2 or more lines compared to 10 percent in the sham-injected group, a 240 percent relative treatment effect (p=0.003); and 18 percent of Macugen patients gained 3 or more lines compared to 7 percent in the sham-injected group, a 157 percent relative treatment trend. The FDA has given fast-track designation to Macugen for both wet age-related macular degeneration and DME.

• Genaera Corp., of Plymouth Meeting, Pa., opened enrollment in the first Phase II trial of its systemically administered anti-angiogenic drug, squalamine, for wet age-related macular degeneration (AMD). The trial is designed to evaluate 18 patients with wet AMD at three different doses of squalamine, which is designed to directly interrupt and reverse multiple facets of the angiogenic process.

• GTC Biotherapeutics Inc., of Framingham, Mass., entered agreements with the Mayo Clinic in Rochester, Minn., to begin preclinical development of an agonistic antibody to CD137 as a potential therapeutic for solid tumors. The antibody was identified and underwent earlier stage research at Mayo Clinic. GTC's initial development work will be substantially funded by a recently awarded Phase I grant from the National Cancer Institute of the National Institutes of Health in Bethesda, Md. GTC will produce and purify the CD137 antibody and Mayo Clinic will collaborate on preclinical testing.

• Harvard Bioscience Inc., of Holliston, Mass., said its MAIA Scientific wholly owned subsidiary, along with The Automation Partnership in Royston, UK, completed a collaboration to incorporate MAIA's microscopy reader technology into TAP's Cello automated-cell culture system to create a product that can culture multiple cell lines in parallel throughout all stages of their life cycle, from seeding through expansion and subcloning.

• HTG Inc., of Tucson, Ariz., said Merck & Co. Inc., of Whitehouse Station, N.J., signed a licensing and supply agreement for HTG's ArrayPlate qNPA (quantitative nuclease protection assay) technology, a product for drug discovery, lead optimization, metabolism, safety assessment and clinical development.

• IGI Inc., of Buena, N.J., signed a sublicense agreement with Tarpan Therapeutics Inc. for the clinical uses of PTH 1-34 relating to the regulation of cell differentiation and proliferation for treating skin disorders using IGI's Novasome delivery technology. A prior study showed that treatment with Novasome A cream containing PTH 1-34 produced a 67.3 percent improvement in treating psoriasis, compared to a 17.8 percent improvement for placebo. Tarpan will assume all costs for clinical trials and pay IGI an up-front payment and milestone and royalty payments.

• ImClone Systems Inc., of New York, priced $500 million of convertible senior notes due 2024. They will bear interest at 1.375 percent per year, payable semi-annually, and their initial purchasers have a 30-day option to purchase up to an additional $100 million worth of the notes on the same terms. The notes will be convertible into the company's common stock under certain circumstances at an initial conversion price of $94.69 per share, representing a premium of 42 percent to Monday's closing bid of $66.68. ImClone said it would use the proceeds for working capital and general corporate purposes, including the possible repayment of its outstanding debt. The offering is expected to close May 7.

• Integra LifeSciences Holdings Corp., of Plainsboro, N.J., said its Integra NeuroSciences unit launched a 5- by-7-inch version of the DuraGen Plus Dural Graft Matrix in the U.S. The collagen matrix graft product is designed for the repair of large defects in the dura mater.

• Lorus Therapeutics Inc., of Toronto, began a clinical trial of GTI-2040 combined with oxaliplatin and capecitabine in patients with advanced unresectable colon cancer. The company said a key objective of the study is to establish the combination's optimal dose and the pharmacodynamic effects on cellular markers of antitumor activity when the agents are combined. The trial is one of six studies in a Phase II program for GTI-2040 sponsored by the Cancer Therapy Evaluation Program, a National Cancer Institute program that helps accelerate the development of certain compounds. GTI-2040 targets the R2 component of ribonucleotide reductase, which is required for DNA synthesis and cell proliferation.

• The National Center for Genome Resources in Santa Fe, N.M., was awarded $1.2 million by the Agricultural Research Service of the U.S. Department of Agriculture to continue development of the Legume Information System (LIS). LIS is a component of the Model Plant initiative, established by Congress to translate information and discoveries from well-studied plant species to economically critical legumes, such as soybeans, peanuts and alfalfa.

• Neurocrine Biosciences Inc., of San Diego, said data from a study in healthy volunteers reported at the American Psychiatric Association meeting in New York showed that immediate-release indiplon, when taken in the middle of the night, is safe and well tolerated without evidence of next-day residual effects. The data showed that 10-mg or 20-mg doses administered in the middle of the night were well tolerated, and subjects did not experience next-morning residual effects as compared to placebo.

• Neurome Inc., of La Jolla, Calif., said findings published in the May 4, 2004, issue of Proceedings of the National Academy of Sciences detail its third phase of analysis of a mouse model of Alzheimer's disease from Elan Corp. plc, of Dublin, Ireland. The analysis revealed a specific form of cellular pathology of nerve cells in the region of the hippocampus that earlier Neurome work had shown to be affected before amyloid deposits could be seen. The company said its findings suggest that the reduced volume in the dentate gyrus region of the hippocampus is the consequence of an extensive loss of dendrites in the same region.

• Phylogeny Inc., of Columbus, Ohio, got a $1.1 million grant from the state of Ohio that it plans to use to launch manufacturing of its next generation of tissue arrays, which feature a maximum amount of retained RNA and protein content.

• Progen Industries Ltd., of Brisbane, Australia, said it received orphan drug designation from the FDA for its lead anti-angiogenesis product, PI-88, to treat malignant melanoma. The product is one of a new class of multitargeted cancer therapeutics inhibiting both angiogenesis or tumor-promoting factors, such as vascular endothelial growth factor, fibroblast growth factors 1 and 2, and heparanse, an enzyme implicated in tumor metastasis. PI-88 is in a Phase II program as a single-agent therapy in multiple myeloma and metastatic melanoma, in combination with chemotherapy for advanced non-small-cell lung cancer, and as an adjuvant treatment in post-operative primary liver cancer.

• Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., began Phase I trials of a new HIV therapy, PRO 140, a humanized monoclonal antibody designed to block infection by inhibiting the ability of the virus to enter healthy cells. PRO 140 blocks the CCR5 co-receptor, one of the principal portals HIV uses to enter cells. Progenics said scientists believe PRO 140 has the potential to combat the rise in drug-resistant strains of HIV, lessen treatment-related toxicities and simplify complex multidrug regimens. The double-blind, randomized, placebo-controlled program will use escalating doses of PRO 140 in healthy volunteers.

• Sangamo BioSciences Inc., of Richmond, Calif., was awarded a $2 million Advanced Technology Program grant to conduct research on an application of its zinc finger DNA-binding protein transcription factor technology. The grant was awarded by the National Institute of Standards and Technology in Gaithersburg, Md., and will be paid over a three-year period.

• Sanochemia Pharmazeutika AG, of Vienna, Austria, opened a U.S. subsidiary called Sanochemia Corp. in Westport, Conn. The company said its Fluorognost HIV-2 confirmation assay remains under FDA review. The product would supplement its Fluorognost HIV-1 confirmation product.

• Stanford University in Palo Alto, Calif., said researchers at its medical center published findings in this month's issue of Nature Biotechnology showing that certain types of cells from fat tissue can repair skull defects in mice. Assessing new bone formation after two and 12 weeks, they found that the fat-derived cells were just as effective as bone marrow cells at synthesizing new bone to bridge the defect. In contrast, cells derived from tissue that covers the brain showed no bone growth during the same time period.

• Syrrx Inc., of San Diego, received an Advanced Technology Program grant to facilitate the development of nanoscale arrays and processes that improve the crystallization of medically important proteins for further investigation as possible targets for new medicines. Syrrx said it is proposing to develop a suite of nanoscale technologies designed to improve the speed and success rate for crystallizing a broad class of proteins associated with cell membranes.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., said preclinical data reported at the International Conference for Antiviral Research in Tucson, Ariz., suggest the potential for oral combination approaches in treating hepatitis C virus infection. Findings demonstrated that merimepodib, Vertex's lead oral HCV therapy, and VX-950, an investigational HCV protease inhibitor, exhibited enhanced antiviral activity when dosed in combination in HCV replicon cells.

• Vicuron Pharmaceuticals Inc., of King of Prussia, Pa., said Phase II data reported at the European Congress of Clinical Microbiology and Infectious Diseases in Prague, Czech Republic, demonstrated superior efficacy of dalbavancin, the company's next-generation injectable glycopeptide antibiotic, compared to vancomycin, the current standard for catheter-related bloodstream infections. The primary endpoint showed there was an overall response rate of 87 percent in 23 patients who received once-weekly dalbavancin, compared to 50 percent in the 28 treated twice daily with vancomycin. Vicuron expects to file a new drug application with the FDA by the end of this year, following two Phase III trials of once-weekly dalbavancin for skin and soft-tissue infections. Other data reported at the meeting showed that the company's lead product, anidulafungin, was the most potent when compared to five other antifungal agents against Candida infections.

• ViroLogic Inc., of South San Francisco, said it signed an expanded referral testing agreement to be the preferred provider of HIV phenotypic-resistance testing for Quest Diagnostics Inc., of Van Nuys, Calif. The agreement will expand ViroLogic's distribution capabilities for its HIV drug-resistance assays, specifically its PhenoSense GT and PhenoSense HIV test. No other terms were disclosed.