• Aastrom Biosciences Inc., of Ann Arbor, Mich., received a Small Business Innovation Research grant from the National Institutes of Health in Bethesda, Md., to demonstrate the feasibility of using the AastromReplicell System for the production of completed dendritic cell-based vaccines for the immunotherapy of ovarian cancer. The study will evaluate and demonstrate the feasibility of using the system, a GMP-compliant, integrated, fully-automated system, to produce sufficient clinical quantities of antigen-loaded dendritic cells to perform a complete immunotherapy treatment in patients with ovarian cancer.

• AGY Therapeutics Inc., of South San Francisco, said its senior vice president of drug discovery and development, Roman Urfer, is presenting at the Treatment of Stroke and Neuroprotection conference in London this week. Urfer will discuss the discovery of two stroke targets, one in the area of acute neuroprotection and the other in post-stroke functional recovery enhancement - the two areas of stroke therapeutic intervention to which AGY applies its functional genomics research technologies.

• AMDL Inc., of Tustin, Calif., said it issued about 1.2 million shares of stock and received gross proceeds of $770,000. It also announced that through Sept. 12, about 1.5 million shares had been issued upon the exercise of warrants included in its private offering completed in July, and it received gross proceeds of an additional $599,247. The company said it would use the funds "in part, to continue the clinical trials required for the [FDA] clearance for our DR-70 test kit and the balance will be available for our general working capital needs."

• AnaSpec Inc., of San Jose, Calif., acquired HiLyte Biosciences Inc., also of San Jose. AnaSpec said the acquisition combines HiLyte's fluorescent probes with AnaSpec's antibodies to generate reagents and kits. HiLyte's co-founder, Zhenjun Diwu, will become the chief scientific officer at AnaSpec, a supplier of peptides and antibodies. Financial terms were not disclosed.

• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, said its corporate partner, Boston Scientific Corp., of Natick, Mass., reported nine-month results from its TAXUS IV clinical trial, at the Transcatheter Cardiovascular Therapeutics meeting in Washington. The pivotal trial of the Taxus Express coronary stent system, which uses Angiotech's paclitaxel-coated stent technology, resulted in a target lesion revascularization rate of 3 percent in the Taxus group compared to 11.3 percent in the control group (p<0.0001). Angiotech's stock (NASDAQ:ANPI) gained $5.85 Monday, or 13.3 percent, to close at $49.70.

• Antares Pharma Inc., of Exton, Pa., converted all its existing debt to equity. The 8 percent convertible debentures held by Xmark Fund LP, Xmark Fund Ltd. and SDS Merchant Fund LP have been exchanged for shares of Series D convertible preferred stock. The stock is nonvoting and is convertible into about 2.4 million common shares, the same number into which the debentures were convertible. The funds also agreed to terminate the security interest they held in Antares' assets. At the same time, its largest shareholder, Jacques Gonella, converted short-term debt owed to him into about 2.4 million common shares at $1 apiece. The company also issued him a five-year warrant to purchase about 1.8 million additional common shares at an exercise price of $1.25 apiece.

• Arizeke Pharmaceuticals Inc., of San Diego, gained exclusive rights from Copernicus Therapeutics Inc., of Cleveland, to patents related to the development of targeted smart drugs that are absorbed systemically following oral or aerosol delivery. Those therapeutics gain entry to the blood as a consequence of binding to the polymeric immunoglobulin receptor (pIgR), a cell-surface protein expressed by gut and lung epithelial cells. The patents sublicensed to Arizeke are based upon technologies that were discovered in the laboratory of Pamela Davis of Case Western Reserve University and Rainbow Babies & Children's Hospital of University Hospitals of Cleveland, and exclusively licensed to Copernicus. Financial terms were not disclosed.

• Chiron Corp., of Emeryville, Calif., said Chairman Sean Lance intends to retire from active service with Chiron and its board of directors as of the annual meeting in May 2004. The board has determined that it will elect Chiron President and CEO Howard Pien as chairman at the meeting.

• DOR BioPharma Inc., of Miami, said the University of Texas Southwestern Medical Center in Dallas, its partner in the development of its recombinant ricin vaccine program, has received a $2.6 million grant from the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health in Bethesda, Md. The grant will be used to further preclinical studies on the safety and efficacy of the vaccine using a ricin aerosol challenge model. It also will compare formulations of the vaccine designed to induce systemic vs. mucosal immunity. DOR also reported it was awarded a Phase I Small Business Innovation Research grant for $150,000 over a six-month period.

• Endo Pharmaceuticals Inc., of Chadds Ford, Pa., said it exercised its option to convert its community-based contract sales force to Endo employees from the contract sales organization Ventiv Health US Sales Inc., which becomes effective Dec. 15. That will bring Endo's internal sales force to a total of 231 sales representatives, it said. The company focuses on pain management products.

• EPIX Medical Inc., of Cambridge, Mass., said it would report data related to its contrast agents during this week's Transcatheter Cardiovascular Therapeutics meeting in Washington. One presentation will detail Phase III results from a study of MS-325, an MRI contrast agent being co-developed with Schering AG, of Berlin. The product is the subject of a new drug application for a vascular disease diagnostic indication. Also, EPIX's preclinical MRI contrast agent designed to image blood clots, EP-2104R, will be the subject of a poster presentation.

• Exelixis Inc., of South San Francisco, said it and the FDA reached agreement on the Phase III trial of XL119, its small-molecule cancer compound, through a special protocol assessment process. The company is looking to initiate a Phase III trial of XL119 in bile duct tumors in the first half of 2004. A Phase II trial in 33 patients with bile duct tumors treated with XL119 showed encouraging results relative to overall survival and progression-free survival, it said. Also, data from a Phase II trial in 36 patients with non-small-cell lung cancer also showed encouraging results relative to survival.

• Generex Biotechnology Corp., of Toronto, said the National Cancer Institute awarded it a Small Business Innovation Research grant of $444,000 to support development of a vaccine for T-helper cell-stimulating peptide vaccines to treat malignant melanoma. The grant supports the design, synthesis and testing of potent Ii-Key/melanoma peptides for possible subsequent clinical studies. The laboratory experiments will be performed in test tubes with lymphocytes from melanoma patients.

• Genzyme Corp., of Cambridge, Mass., said it completed its acquisition of SangStat Medical Corp., of Fremont, Calif., for $22.50 per share. The $600 million cash transaction then included a merger of Genzyme's wholly owned subsidiary into SangStat. SangStat's shares have been delisted from the Nasdaq exchange. The deal was reported last month. (See BioWorld Today, Aug. 5, 2003.)

• Genzyme Corp., of Cambridge, Mass., said the European Commission authorized an expanded indication for Cerezyme (imiglucerase) to include Type 3 Gaucher's disease, the chronic neuropathic form of the disease. The decision follows the positive opinion issued in June by the European Committee for Proprietary Medicinal Products on expanding the label.

• Gilead Sciences Inc., of Foster City, Calif., completed the purchase of its Foster City campus from a subsidiary of Equity Office Properties Trust for about $123 million. The company entered an agreement to purchase the facility in August. Gilead acquired 16 buildings, totaling 496,000 square feet of office and laboratory space. The company occupies eight of the 16 buildings.

• Gryphon Therapeutics Inc., of South San Francisco, received a $2 million grant from the National Institute of Standards and Technology's Advanced Technology Program. The three-year grant will fund the company's program to validate a drug development platform designed to generate peptides composed of D-amino acids as pharmaceuticals. Gryphon said it will use the grant to synthesize the mirror image of native tumor necrosis factor alpha using D-amino acids and its chemical protein synthesis technology.

• Labopharm Inc., of Laval, Quebec, completed the treatment stage for two pivotal Phase III trials in the U.S. for its lead in-house product, a once-daily version of the analgesic tramadol. The company expects to report the results from the trials during the fourth quarter. Tramadol is a centrally acting analgesic for moderate to moderately severe pain that might be associated with conditions such as osteoarthritis, lower back spasm, cancer and other acute and chronic conditions, it said.

• Lorus Therapeutics Inc., of Toronto, said approval was obtained from Health Canada for initiation of a clinical trial of GTI-2040 in combination with docetaxel for the treatment of advanced non-small-cell lung cancer, as part of a Phase II program of GTI-2040 in collaboration with the National Cancer Institute in Bethesda, Md. The study will be conducted at Princess Margaret Hospital in Toronto. GTI-2040 is an antisense drug that specifically targets the R2 component of ribonucleotide reductase, it said.

• MGI Pharma Inc., of Minneapolis, began sales and marketing of Aloxi (palonosetron hydrochloride) injection in the U.S. Aloxi was approved by the FDA in July at a fixed dose of 0.25 mg for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy and for the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. Aloxi is a 5-HT3 receptor antagonist.

• Molecular Insight Pharmaceuticals Inc., of Cambridge, Mass., said it will proceed with Phase III trials of its molecular imaging pharmaceutical, (123I)-BMIPP, for the visualization of cardiac metabolism. It based the decision on positive results of its Phase II studies presented at the annual scientific meeting of the American Society of Nuclear Cardiology in Indianapolis. It said it looks "forward to initiating our Phase III trials in the months ahead."

• Mologen Holding AG, of Berlin, is now in operation, resulting from the merger of Mologen GmbH and Soft Gene GmbH. The move was made to "increase transparency for investors and lead to a further reduction in administrative costs," it said. The company uses DNA technologies to develop treatments for illnesses.

• Odyssey Thera Inc., of San Ramon, Calif., and Dharmacon Inc., of Lafayette, Colo., formed a research collaboration to study the effects of siRNA-induced gene silencing on cellular signaling pathways. The collaboration will combine Dharmacon's SMART technologies for gene silencing and Odyssey Thera's Protein-fragment Complementation Assay process in the quantification and analysis of signaling events within the context of living human cells. Dharmacon will design and synthesize SMARTpool siRNA reagents for targets selected by Odyssey that have been associated with disease-related events such as angiogenesis, apoptosis and inflammation. Odyssey Thera researchers will use the siRNA reagents with its PCA technology to analyze in living human cells how protein signaling events are affected when certain genes are targeted for silencing. Financial terms were not disclosed.

• Panacea Pharmaceuticals Inc., of Gaithersburg, Md., signed an agreement with Massachusetts General Hospital/Harvard University granting the company exclusive, worldwide rights to develop and commercialize diagnostic and therapeutic products based on a patented cancer target. The target is a protein expressed on the surface of cancer cells including those of the colon, liver and pancreas. A monoclonal antibody, SF-25, has been developed against the protein. Financial terms were not disclosed.

• Peplin Biotech Ltd., of Brisbane, Australia, said its collaboration with the CRC for Bioproducts to explore biosynthetic methods of producing anticancer compounds yielded promising results. Contract research conducted by CRC in Sydney and Melbourne demonstrated in vitro anticancer activity from compounds produced by a cell line from a plant species that had not previously been taken into cell culture.

• PhyNexus Inc., of San Jose, Calif., developed a technology for extracting and studying proteins. PhyNexus' lab tools are designed to extract, purify and enrich proteins from micro-volume biological samples. The company's protein extraction and isolation technology is designed to deliver greater accuracy and improved purity.

• Rigel Pharmaceuticals Inc., of South San Francisco, said its researchers, in an attempt to find new regulators of the immune system, created a method for discovering targets that are involved in signaling pathways. As published this week in the Journal of Biology, the team conducted a functional genome-wide screen and discovered modulators of T-cell receptor signaling that could aid in the development of drugs that target immune response, the company said. The experiments confirmed that the genes EDG1, PAK2 and the previously unidentified TRAC-1 were normally expressed in the lymphoid system and that truncated versions of their proteins could repress T-cell receptor signaling in T cells.

• SkyePharma plc, of London, said it welcomes the recent report by partner Astralis Ltd., of Fairfield, N.J., that it initiated a Phase I trial in the U.S. for Psoraxine, an injectable treatment for moderate psoriasis. A first-generation version of Psoraxine already was studied in Venezuela. SkyePharma is providing development, manufacturing, preclinical and clinical development services to Astralis for a second-generation version of Psoraxine, up to the completion of Phase II studies.

• The Medicines Co., of Parsippany, N.J., reported at the 2003 Transcatheter Cardiovascular Therapeutics conference in Washington six-month results of the REPLACE-2 trial that included numerically lower death rates in Angiomax randomized patients as compared to patients randomized to heparin with glycoprotein IIb/IIIa inhibitors. Angiomax is a synthetic product approved for use in unstable angina patients undergoing coronary angioplasty. The trial involved 6,002 patients.

• Therion Biologics Corp., of Cambridge, Mass., developed a vaccine that was used in a study published in Clinical Cancer Research. Details from the Phase II study conducted by the National Cancer Institute in Bethesda, Md., showed that administration of a prototype vaccine, developed by Therion, administered in combination with interleukin-2, generated objective tumor response in six of 12 treated patients with metastatic melanoma, three of whom remained free of disease at 16, 18 and 26 months, respectively.

• U3 Pharma AG, of Martinsried, Germany, closed a €13.25 million second-round financing co-led by Atlas Venture, of London, and LCF Rothschild Venture Partners, of Paris. It also included the BioMedical Sciences Investment Fund, of Singapore; Alta Partners, of San Francisco; BioM, of Munich, Germany; and Medicis Venture Management, of Munich. Proceeds will be used to advance cancer candidate drugs through investigational new drug applications and into clinical development. The company is developing products based on targeting specific components of cellular transduction systems.

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