• Aastrom Biosciences Inc., of Ann Arbor, Mich., initiated its U.S. clinical trial of its bone generation Tissue Repair Cell stem cell product at a site in Chicago. Aastrom will study the TRCs at up to three centers for the treatment of tibial non-union fractures. The company expects to enroll as many as 20 patients.

• Applied Biosystems Group, of Foster City, Calif., said its SNPlex Genotyping System is now commercially available. The system is a reagent and software product designed to allow researchers to conduct ultra-high-throughput genotyping studies to characterize complex diseases using the company's 3730xl and 3730 DNA Analyzers.

• Auxeris Therapeutics Inc., of St. Louis, acquired all technology assets from Ceros Pharmaceuticals Inc., of Houston. Ceros' oral bone-forming therapy and other bone-related technology were developed by Gerard Karsenty of Baylor College of Medicine. Based on his work, Auxeris is developing the first oral bone anabolic agent for the prevention and treatment of osteoporosis. Terms of the agreement were not disclosed.

• Bioenvision Inc., of New York, reported that enrollment began and the first five patients were dosed in a Phase II trial of clofarabine for the treatment of acute myelogenous leukemia (AML) in older adults who are not considered suitable for intensive chemotherapy. Clofarabine was granted an orphan medicinal product designation by the European Agency for the Evaluation of Medicinal Products as a treatment for acute lymphocytic leukemia and AML in Europe.

• BioSyntech Inc., of Laval, Quebec, filed a preliminary prospectus with regulatory authorities in Quebec, Ontario, Manitoba, Alberta and British Columbia for the sale of an as-yet undetermined number of common shares and warrants. The offering is being marketed through Canaccord Capital Corp. BioSyntech, which is developing and manufacturing regenerative medicine products and therapeutic delivery systems, has applied to list its shares on a recognized Canadian exchange. It already trades on the Over-the-Counter Bulletin Board.

• Chemicon International Inc., of Temecula, Calif., a division of Serologicals Corp., entered an exclusive licensing agreement with Myriad Genetics Inc., of Salt Lake City, for the research use of Myriad's tumor suppressor and breast cancer susceptibility proteins and antibodies. Chemicon obtains rights to BRCA1, BRCA2, p16, p15 and p14. The agreement excludes commercial therapeutic and diagnostic rights and rights to fields of use that Chemicon does not serve.

• Chiron Corp., of Emeryville, Calif., formed a collaboration with Australia-based CSL Ltd. to develop a therapeutic hepatitis C vaccine. Chiron will provide its hepatitis C virus antigens, and CSL will contribute its Iscomatrix adjuvant technology. Financial terms were not disclosed.

• Corixa Corp., of Seattle, and GlaxoSmithKline Biologicals, of Rixensart, Belgium, received FDA approval of an investigational new drug application and plan to initiate a Phase I study to evaluate the safety and immunogenicity of a prophylactic vaccine for tuberculosis. The trial will be conducted in the U.S.

• Cytokinetics Inc., of South San Francisco, reported that GlaxoSmithKline plc, of London, initiated a Phase II program to expand the development of SB-715992, a small-molecule oncology drug directed against kinesin spindle protein, a cytoskeletal protein essential for DNA division. The program, which is scheduled to continue through 2004, is expected to encompass multiple, parallel Phase II monotherapy and Phase Ib/II combination therapy studies across a range of tumor types.

• Direvo Biotech AG, of Cologne, Germany, will receive a €3.9 million grant from the state government of North Rhine-Westphalia to fund a pharmaceutical development project over four years. The aim of the project, in which Direvo is generating therapeutic proteins in a specific disease area, is to promote innovation with high technological and economic potential. The company also entered an enzyme optimization collaboration with an undisclosed partner. Direvo will receive research and development funding, milestone payments and potential royalties in exchange for using its technologies to improve an enzyme in the area of food and feed.

• Diversa Corp., of San Diego, received milestone payments of $1.7 million under its agreements with Syngenta AG, of Basel, Switzerland, for achievements attained in 2003. In the past year, Diversa delivered product candidates for feed- and food-processing applications to Zymetrics, its joint venture with Syngenta, triggering development milestone payments. Additionally, Zymetrics' Quantum Phytase animal-feed enzyme received regulatory approval in Mexico.

• Enzo Biochem Inc., of Farmingdale, N.Y., said a Phase I/II study of its Stealth Vector HGTV43 gene construct for HIV infection began at New York Presbyterian Hospital-Weill Medical College of Cornell University. The trial's objective is to increase the number of engineered cells containing the anti-HIV-1 antisense RNA genes in circulation.

• Evotec OAI AG, of Hamburg, Germany, formed a medicinal chemistry partnership with Rib-X Pharmaceuticals Inc., of New Haven, Conn. Evotec will use its integrated medicinal chemistry and parallel synthesis platform to facilitate privately held Rib-X's efforts to identify antibiotics for clinical development. Financial terms were not disclosed.

• Exagen Diagnostics Inc., of Albuquerque, N.M., reported the closing of its Series A financing, which raised more than $5.4 million. Exagen is in the process of validating a breast cancer prognostic that will help physicians determine which newly diagnosed patients should consider aggressive treatment and is developing a hepatitis C prognostic that will identify patients who are most likely to respond to treatment with interferon and ribavarin. Exagen was founded in 2002 as a spin-off of Quasar International Inc., also of Albuquerque.

• Genedata AG, of Basel, Switzerland, and Schering AG, of Berlin, expanded their four-year collaboration. Schering extended the license for Expressionist, the Genedata computational system for large-scale gene-expression analysis in the pharmaceutical industry. Genedata will provide consulting services to Schering. Financial details were not disclosed.

• Genzyme Corp., of Cambridge, Mass., reported that the Federal Trade Commission closed its review of the company's acquisition of Novazyme Pharmaceuticals Inc. The FTC review sought to determine whether there were anticompetitive aspects of the transaction. Genzyme acquired Novazyme in September 2001. The acquisition did not require premerger notification under the Hart-Scott-Rodino Antitrust Improvements Act. Separately, Genzyme said it would open a research facility in Cambridge, UK, to bring Genzyme into proximity with a cluster of nearly 200 biotechnology companies and a pool of scientific talent, it said. (See BioWorld Today, Aug. 8, 2001.)

• GPC Biotech AG, of Martinsried, Germany, said it has received about $1.5 million in milestone payments triggered by progress in its five-year alliance with the Altana Research Institute, a division of Altana Pharma AG, of Bad Homburg, Germany. The achievements included two implementation milestones, the validation of transferred technologies and related automation, as well as research milestones under the drug discovery collaborations that are part of the agreement with the institute. The research milestones included the successful performance of LeadCode screens on several compounds of interest, the completion of a pathway-mapping screen and the generation of a specialized clone library for use in the collaborations.

• Hard to Treat Diseases Inc., of Delray Beach, Fla., said results of a Tubercin pathology report are promising in that Tubercin appears to be nontoxic. The testing of Tubercin on live melanoma, lung and breast cancer cells was initiated and the company is awaiting the results. Tubercin is an immunostimulant developed for combating cancer.

• Hybridon Inc., of Cambridge, Mass., filed a registration statement to sell up to 20 million common shares from time to time. The company said it plans to use any resulting proceeds for research and development activities, including costs of conducting preclinical studies and clinical trials, as well as for working capital and other general corporate purposes.

• Illumina Inc., of San Diego, said it entered the whole-genome gene-expression market with the launch of two new Sentrix BeadChips. The product offerings are intended to advance the field of genetic analysis by enabling high-performance, cost-effective, whole-genome expression profiling of multiple samples on a single chip. Illumina's new six-sample whole-genome BeadChip will compete with recently reported microarray products analyzing one genome on a chip. The first BeadChip is designed to analyze six discrete whole-human genome samples on one chip.

• Incara Pharmaceuticals Corp., of Research Triangle Park, N.C., completed a toxicology study for AEOL 10150, issued a $5 million convertible debenture to Goodnow Capital LLC and made an initial draw of $1 million on the debenture. In the fall, Incara said the $5 million financing agreement was subject to a reorganizational merger, which was completed in November, and Goodnow's acceptance of the toxicology study, among other conditions. Goodnow is an investment entity controlled by the Xmark Funds in New York. The satisfactory toxicology results are expected to allow Incara to proceed with filing AEOL 10150's investigational new drug application for amyotrophic lateral sclerosis.

• InKine Pharmaceutical Co. Inc., of Blue Bell, Pa., said it expects to begin a Phase II study in the first half of this year to evaluate a new generation of colon-cleansing tablets. Several dosing regimens of the new purgative tablets, which are smaller and contain no microcrystalline cellulose, will be compared to Visicol, InKine's marketed purgative product, in patients undergoing colonoscopy. The regimens will include one similar to the approved regimen for Visicol, as well as several at a lower dose, including those completed by patients the evening before the procedure. The company added that the FDA indicated that if results are supportive, only one pivotal study would be required for approval of the new tablets.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., achieved two milestones in its antisense drug discovery agreement with the Industrial Technology Research Institute, of Hsinchu, Taiwan, for the coronavirus associated with severe acute respiratory syndrome. Isis received $1 million for the identification of potent, second-generation antisense drugs that inhibit SARS virus replication and the successful completion of preclinical studies evaluating aerosol and parenteral delivery of antisense drugs.

• Manhattan Pharmaceuticals Inc., of New York, completed a private placement of about 3.4 million shares of its common stock resulting in gross proceeds of $3.7 million before payment of company expenses and commissions of about $266,000. The proceeds will be used to fund clinical and nonclinical research and development, working capital and general corporate purposes. Manhattan Pharmaceuticals develops prescription drugs for underserved patient populations.

• MediGene AG, of Martinsried, Germany, named Tokyo-based Yamanouchi Pharmaceutical Co. Ltd. as its pan-European marketing partner for the Eligard prostate cancer products licensed from Atrix Laboratories Inc., of Fort Collins, Colo. Eligard received marketing authorization in Germany earlier this month for advanced prostate cancer.

• Neurochem Inc., of Montreal, said its independent data safety monitoring board made a third recommendation to continue the company's pivotal Phase II/III trial of Fibrillex, its orphan drug candidate for amyloid A amyloidosis, a disorder associated with chronic inflammatory and infectious diseases. The recommendation was based on a review of safety data from 183 patients, of whom 77 have completed at least 12 months of the study. At the same time, Neurochem said all of its programs remain on schedule and that there are no company events, nor any pending news, to justify its current stock volatility. Its stock (NASDAQ:NRMX) dropped $2.59 Wednesday, or 11 percent, to close at $21.05.

• Orchid BioSciences Inc., of Princeton, N.J., filed a shelf registration statement permitting the company to offer and sell up to $30 million of its common stock from time to time. The company said the shelf registration would give it additional flexibility in accessing capital markets to pursue new growth opportunities. Orchid provides genomic and DNA testing services.

• Sequenom Inc., of San Diego, entered a collaboration with LGC Ltd., of Teddington, UK, a provider of analytical and diagnostic services, to develop and validate a genetic marker panel for paternity and forensic identification. Successful results will enable LGC to use the validated panel of single nucleotide polymorphism assays on Sequenom's MassArray platform to provide paternity and forensic testing services.

• Sienabiotech SpA, of Siena, Italy, entered an agreement to implement the ActivityBase suite of technology from IDBS, of Guildford, UK. Sienabiotech, a research-based drug discovery company focused on central nervous system disorders, will use the product in lead discovery to capture, manage and integrate biological, chemical and inventory data.

• Stanford University in Palo Alto, Calif., said its researchers would publish findings in next month's issue of Nature Genetics describing a protocol for making a short interfering RNA (siRNA) library to obstruct expression of all genes in a given cell, including genes that were previously uncharacterized. The researchers said the technique of creating siRNA molecule libraries could be used to find genes that, when disabled, cause cells to become cancerous or alter how the cells respond to different drugs. The genes could then become potential targets for drugs to treat disease.

• V.I. Technologies Inc., of Watertown, Mass., raised $6.6 million after agreeing to sell about 7.3 million common shares to institutional investors at 90 cents apiece. The investors also will receive a five-month option to purchase about 1.8 million additional shares at 90 cents per share and four-year warrants to purchase about 2.9 million shares, exercisable for cash only, at $1.32 apiece. Vitex expects to use the proceeds to fund the ongoing clinical development of its Inactine Pathogen Reduction System for red blood cells and for general working capital purposes. SG Cowen Securities Corp. acted as the transaction's exclusive placement agent.

• WaferGen Inc., of Fremont, Calif., a company focused on developing tools to increase data collection and analysis opportunities, launched its operations. The company was formed to apply the experience of management in the design and manufacture of complex systems for high-tech applications to the life sciences industry. The company is attracting experts in semiconductors, nanotechnology, MEMS, optics and biochemistry.

• Wilex AG, of Munich, Germany, began a Phase Ib trial of WX-UK1 in head and neck cancer patients. The study is designed to assess the safety, tolerability and biological activity of the drug candidate, a non-cytotoxic, small-molecule inhibitor of the urokinase-type plasminogen activator system. Patients will be treated at escalating doses in order to determine the maximum tolerated dose, which when determined will be administered to 18 patients for four weeks. In addition, concentrations of WX-UK1 in tumor tissue will be assessed.

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