• Adolor Corp., of Exton, Pa., said Phase III data published in next month's Annals of Surgery show that Entereg (alvimopan) capsules accelerated gastrointestinal recovery in patients undergoing laparotomy for bowel resection or radical hysterectomy. Also, the data indicated that hospital-discharge orders were written for patients taking 12 mg of Entereg about one day earlier than those taking placebo. Those data and findings from two other Phase III studies are part of a new drug application that has been accepted by the FDA. The product is partnered with GlaxoSmithKline plc, of London, and the companies began submitting the NDA earlier this year. (See BioWorld Today, May 10, 2004.)

• Advanced Cell Technology Inc., of Worcester, Mass., said research to be published in the fall issue of Cloning and Stem Cells details the first generation of human retinal cells in the laboratory from human embryonic stem cells. The company said some of the retinal tissues, such as retinal pigment epithelium, might provide a new therapeutic strategy for diseases such as macular degeneration, retinitis pigmentosa and other retinal degenerative diseases. The research was carried out by the company and collaborators at the University of Chicago and Wake Forest University.

• Antares Pharma Inc., of Exton, Pa., said the American Stock Exchange began listing its common stock as "AIS." The specialty pharmaceutical company uses drug delivery systems to improve product performance.

• Aphton Corp., of Miami, and XOMA Ltd., of Berkeley, Calif., signed a worldwide collaboration agreement for the treatment of gastrointestinal and other gastrin-sensitive cancers using anti-gastrin monoclonal antibodies. Aphton and XOMA will share all development expenses and commercialization profits and losses for product candidates on a 70-30 basis, respectively. XOMA will have worldwide manufacturing rights for the products and the ability to share up to 30 percent in the commercialization efforts in the U.S. Aphton will have exclusive rights to commercialize products outside the U.S. The antibodies to be developed will bind and neutralize the hormones gastrin 17 and gly-gastrin 17 that are known to be involved in tumor progression in gastrointestinal cancers.

• BioAdvance, of Philadelphia, and Quaker BioVentures, of Wayne, Pa., closed a new $26 million fund called BioAdvance Ventures LP. The fund is sponsored by BioAdvance and managed by Quaker to provide early stage funding to life sciences companies in southeastern Pennsylvania and other areas of the state. BioAdvance was established in 2002 with $33.8 million from the state's share of tobacco-settlement monies.

• Bioenvision Inc., of New York, began enrollment in a Phase II study of Modrenal (trilostane) for prostate cancer. The trial targets patients who are androgen-independent and have rising prostate-specific antigen levels. The company expects to enroll up to 43 patients in the multicenter study, which is expected to be completed by the middle of next year.

• Biotech Holdings, of Vancouver, British Columbia, said it is opening an office in Mexico City to coordinate sales and marketing for the Latin American region. Luis Manuel will be based at the new office as vice president of Latin American operations. He will coordinate the launch of Sucanon in Mexico and Peru, and make regulatory applications in a number of other Spanish-speaking markets. Sucanon is a new drug for treating symptoms of Type II diabetes and impaired glucose tolerance.

• Cangen Biotechnologies Inc., of Bethesda, Md., initiated enrollment of patients in a Phase III study to evaluate a diagnostic test for the early detection of bladder cancer. Cangen's noninvasive test detects cancer by identifying genetic alterations in microsatellite DNA in urine. The study has been designed to test the assay's effectiveness in detecting recurrent cancer in 300 bladder cancer patients with the goal of presenting the assay for evaluation by the FDA.

• Corautus Genetics Inc., of Atlanta, received net proceeds of $4.7 million after closing the second of two tranches of a $9.85 million private placement of common stock and warrants first reported in July. Also, the company closed on $2.5 million of the convertible debt facility made available by Boston Scientific Corp., of Natick, Mass., under a July 2003 loan agreement. Corautus has received $20 million of the $25 million commitment from Boston Scientific.

• Cytos Biotechnology AG, of Schlieren, Switzerland, reached its targeted enrollment of 300 smokers in a Phase II trial of its lead Immunodrug candidate, CYT002-NicQb. The primary endpoint of the study, which began in January, is continuous abstinence from smoking, which is determined by self-reporting and confirmed by measuring a long-lasting metabolite of nicotine called cotinine. The company expects initial results in the second quarter of next year.

• DakoCytomation A/S, of Copenhagen, Denmark, began shipping its CyAn ADP instrument platform for flow-cytometry analysis. It provides access to more than 300 research antibodies optimized for the platform.

• Depomed Inc., of Menlo Park, Calif., said preliminary results from its 30-person Phase II trial of Furosemide GR, a controlled-release formulation of the leading diuretic furosemide, indicated that the primary endpoint, comparing Furosemide GR to immediate-release furosemide, was met, with patients experiencing comparable excretion of urine and electrolytes in both treatment groups. Furosemide is used to treat edema in congestive heart failure patients.

• Ecopia BioSciences Inc., of Montreal, obtained results demonstrating that its lead compound, ECO-4601, for brain cancer, crosses the blood-brain barrier. Ecopia scientists will present those and other data at the 16th EORTC-NIC-AACR Symposium in Geneva on Oct. 1. ECO-4601 was discovered using Ecopia's Decipher technology.

• Glenmark Pharmaceuticals SA, a wholly owned subsidiary of Glenmark Pharmaceuticals India, of Mumbai, India, could gain up to $190 million after entering a collaborative agreement centered on its PDE4 inhibitor, GRC 3886, with Forest Laboratories Inc., of New York. Forest will develop, register and commercialize GRC 3886 for the North American market, while Glenmark will retain commercialization rights for the rest of the world. GRC 3886, in development for chronic obstructive pulmonary disorder and asthma, is entering Phase I trials in the UK. Forest will pay Glenmark an up-front payment, followed by milestones if the development and commercialization of the product is successfully completed in the North American market. Should the product be commercially launched, Glenmark would earn a royalty in the mid-teens, and would supply all active pharmaceutical ingredients to Forest.

• GTC Biotherapeutics Inc., of Framingham, Mass., agreed to exclusively license its transgenic technology to Nexia Biotechnologies Inc., of Montreal, as part of the latter's plans to continue the development, manufacture and sale of Protexia. The agreement, for which financial terms were not disclosed, includes access to GTC's beta casein promoter and an option to license its filtration technology, which has been demonstrated to have utility for initial purification of Protexia, a recombinant form of butyrylcholinesterase produced in the milk of Nexia's transgenic goats. Protexia is being developed by Nexia with the U.S. Army Medical Research Materiel Command and with Defence R&D Canada Suffield for therapeutic and prophylactic applications.

• Helix BioPharma Corp., of Aurora, Ontario, raised gross proceeds of C$618,750 (US$483,536) through the issuance of 225,000 units. Each consists of one common share and one common share purchase warrant, and each warrant entitles the holder to purchase one common share at C$4.50 until Sept. 22, 2006. It has raised C$5.3 million this month. The company said it plans to use the financing to fund the preclinical and clinical development of its cancer products, and for working capital and general corporate purposes.

• Lipid Sciences Inc., of Pleasanton, Calif., started a non-human primate study that is being conducted at the Wake Forest University Baptist Medical Center in Winston-Salem, N.C. The study is designed to demonstrate the safety and efficacy of Lipid Sciences' HDL Therapy in treating cardiovascular disease. The therapy is intended to remove cholesterol from HDL to enhance the body's natural process of reverse cholesterol transport. The endpoint of the 24-week study will be the measurement of arterial plaque regression as determined by comparing plaque volume at baseline, the study mid-point and the study conclusion.

• Lorus Therapeutics Inc., of Toronto, said its scientists published results of experimental studies with its lead cancer drug, Virulizin. The data appear in an online Cancer Immunology article. The study, performed in collaboration with McGill University, examined whether a subset of immune cells called natural killer cells are involved in Virulizin antitumor activity. Researchers found that human tumors implanted into mice and treated with Virulizin had an increased number of macrophages and NK cells infiltrated directly into the tumor. In NK-deficient mice, the antitumor activity of Virulizin was compromised.

• Medical Discoveries Inc., of Twin Falls, Idaho, reached agreement with Henry Thompson, director of the CF Program Therapeutics Center at Boise's Cystic Fibrosis Clinic at St. Luke's Health Center to serve as project manager and principal investigator for the Phase I trials of MDI-P in late-term adult cystic fibrosis patients. MDI-P will be used as an adjunct therapy to tobramycin.

• MGI Pharma Inc., of Minneapolis, began marketing Kadian in the U.S. to oncology health care professionals for moderate to severe pain associated with cancer. Kadian will continue to be marketed by Alpharma Inc., of Fort Lee, N.J., to pain specialists in the U.S. Kadian capsules contain identical polymer-coated sustained-release pellets of morphine sulfate.

• MorphoSys AG, of Martinsreid, Germany, formed a marketing cooperation with GeneFrontier Corp., of Tokyo, to establish MorphoSys' HuCAL technology in the Japanese life science market. Under the multiyear collaboration, the parties will invest in customer development and marketing in Japan as part of a wider MorphoSys effort to expand geographically into new markets. Financial terms were not disclosed.

• Neurome Inc., of La Jolla, Calif., entered a research agreement with ImClone Systems Inc., of New York, in which Neurome will apply its technologies and expertise in quantitative neuropathology to assist ImClone in the discovery of preclinical candidate molecules. The partnership will leverage Neurome's experience in central nervous system diseases and technologies to provide ImClone with information on the effects of selected preclinical molecules on potential targets in the central nervous system.

• Novacea Inc., of South San Francisco, enrolled the first patient in its multidose Phase I study of AQ4N, a cancer drug activated by tumor cells with low oxygen levels that are present in solid tumors. Preclinical studies also suggest that AQ4N may have antitumor activity in lymphoid malignancies. AQ4N is Novacea's second product to enter clinical trials.

• NovaDel Pharma Inc., of Flemmington, N.H., began a pilot pharmacokinetic feasibility study in humans of a lingual spray version of alprazolam, an anti-anxiety medication marketed as Xanax by Pfizer Inc., of New York, and as a generic by several producers. The drug's new formulation uses NovaDel's lingual spray drug delivery technology, designed to achieve more rapid onset of therapeutic activity.

• OriGene Technologies Inc., of Rockville, Md., received a Phase I Small Business Innovation Research grant from the National Institutes of Health in Bethesda, Md., through the National Human Genome Research Institute, also in Bethesda. OriGene is a molecular tool provider for system biology studies, using high-throughput gene cloning and gene-expression profiling to develop products for pharmaceutical, biotechnology, and academic research and discovery applications.

• OSI Pharmaceuticals Inc., of Melville, N.Y., said it intends to file a registration statement with the SEC for an offering of up to 5.5 million shares of its common stock, not including the underwriter's overallotment option. OSI exclusively markets Novantrone for oncology and Gelclair for pain associated with oral mucositis. It also is developing a liposomal product designed to mimic a long-term infusion of 5-FU and a co-inhibitor of c-Kit and vascular endothelial growth factor. With partner South San Francisco-based Genentech Inc., OSI recently started a Phase IIIb trial of Tarceva providing access for non-small-cell lung cancer patients, while the companies await an FDA decision on the new drug application filed in July. (See BioWorld Today, Sept. 13, 2004.)

• Pfizer Inc., of New York, will pay $125 million and a contingent payment to purchase the remaining 90 percent of a drug delivery technology company called Meridica Ltd., of Cambridge, UK, from PA Consulting Group, of London. Almost a year ago, Pfizer purchased a 10 percent interest in the company and licensed the rights to Meridica's dry-powder inhaler. The transaction is subject to normal conditions and is expected to close next quarter.

• PharmaStem Therapeutics Inc., of Wayne, Pa., said the Federal District Court in the District of Delaware confirmed a jury's previous findings regarding the validity and enforceability of U.S. Patent Nos. 5,004,681 and 5,192,553. On Oct. 29, 2003, a jury in Delaware found that PharmaStem's patents were valid, enforceable and willfully infringed by the defendants ViaCord, CBR (Cord Blood Registry), Cryo-Cell International and Corcell, PharmaStem said. PharmaStem's patents are licensed to 16 of the 20 private cord blood banks operating in the U.S.

• Savient Pharmaceuticals Inc., of East Brunswick, N.J., said its management, together with adviser UBS Investment Bank, is proceeding exploring a potential divestiture of its Israeli business operations, including its subsidiary, Bio-Technology General (Israel) Ltd. Early in the fourth quarter, a confidential information memorandum is expected to be made available to prospective acquirers. If a satisfactory offer is received and approved by the board, management expects that the transaction could complete in the first half of 2005.

• Seattle Genetics Inc., of Bothell, Wash., initiated a Phase II trial of SGN-30 for the treatment of primary cutaneous anaplastic large-cell lymphoma (ALCL). Primary cutaneous ALCL is the company's third clinical indication for SGN-30. The study is designed to evaluate the antitumor activity and tolerability of SGN-30 in up to 40 patients who have relapsed or are resistant to prior therapies. SGN-30 is a genetically engineered monoclonal antibody that targets CD30+ hematologic malignancies.

• Serono SA, of Geneva, said Raptiva (efalizumab) received European approval for people with moderate to severe chronic plaque psoriasis for whom other systemic treatments or phototherapy have been inadequate or inappropriate. The company said the therapeutic antibody is the first new biological treatment for psoriasis to be authorized in the 25 countries of the European Union, and it plans to launch the treatment in several countries, including Germany and the UK, before the end of the year and throughout the rest of the European Union next year. Outside the U.S. and Japan, Serono has the product's rights. In the U.S., they remain with Genentech Inc., of South San Francisco, and XOMA Ltd., of Berkeley, Calif.

• SuperArray Bioscience Corp., of Frederick, Md., made available its new GEArray Expression Analysis Suite application software, a web-based application designed to help researchers analyze raw microarray images and report gene-expression results.

The U.S. Department of Energy's Joint Genome Institute Production Genomics Facility in Walnut Creek, Calif., along with collaborators at Genome Canada and the Ume Plant Science Centre in Sweden, released the first complete DNA sequence of a tree, Populus trichocarpa. It also is called the black cottonwood or poplar. With a genome consisting of more than 480 million letters of genetic code, Populus trichocarpa was sequenced eight times over.

• VaxGen Inc., of Brisbane, Calif., exchanged the warrants issued through its Series A 6 percent cumulative convertible preferred stock financing in May 2001 for two new series of warrants. The company exchanged all 655,078 Series A warrants for 12-month warrants to purchase about 1.1 million shares of VaxGen's common stock at 1 cent per share, and three-year warrants to purchase 655,078 shares of VaxGen's common stock at $16 per share. The agreements governing the prior warrants were terminated and as a result, VaxGen will no longer be subject to monthly cash penalty payments related to the Series A warrants, and the warrant holders will no longer have the right to redeem the warrants for cash at a premium to the market price.

• ViRexx Medical Corp., of Edmonton, Alberta, received Canadian regulatory authorization to begin a Phase I study of its lead product candidate, Occlusin injection, in liver cancer patients. About 12 patients will be enrolled in the trial, which is designed to examine the product's safety when used as an embolizing agent as part of transcatheter arterial chemoembolization procedures in treating cancer of the liver. It is expected to enroll its first patient within the next several weeks, with results expected in the third quarter of next year.

• Znomics Inc., of Portland, Ore., was awarded a two-year $1.5 million Phase II Small Business Innovation Research grant from the National Institutes of Health in Bethesda, Md. The funding is designed to fund the completion of the ZeneMark Library, a tool for drug and drug target discovery. The research funded by the grant should result in the creation of a library of mutations in all of the genes in the zebrafish.

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