• Aastrom Biosciences Inc., of Ann Arbor, Mich., said that its clinical trial in Barcelona, Spain, will be expanded based on initial results from the first phase of patient treatment. The trial involved five patient treatments using Aastrom's Tissue Repair Cells (TRCs) for the bone graft repair of severe long bone non-union fractures. Results to date show that the TRCs were safe with no adverse events reported, and that patients are exhibiting various early stages of healing.

• Acusphere Inc., of Watertown, Mass., received a $2 million loan from MassDevelopment, which the company plans to use to develop a site to manufacture AI-700, a drug designed to enhance ultrasound's ability to detect coronary heart disease that the company produces outside Massachusetts. Separately, the company said its stockholders approved the proposed issuance and sale of 574,478 common shares and warrants to purchase up to 114,895 additional shares. The shares and warrants are proposed to be sold at the second and final closing of Acusphere's previously announced $21.5 million private placement of securities with certain institutional and accredited investors. (See BioWorld Today, Aug. 3, 2004.)

• Alteon Inc., of Parsippany, N.J., said preclinical findings reported at the World Congress of the International Society for Sexual and Impotence Research in Buenos Aires, Argentina, showed that its lead A.G.E. Crosslink Breaker compound alagebrium demonstrated ability to reverse erectile dysfunction in a model of diabetes. Researchers said that the drug, formerly known as ALT-711, appears to operate by a unique mechanism of action to offer potential for diabetic erectile dysfunction. They added that the data are unlike results for existing erectile dysfunction drugs in similar experiments, particularly due to a beneficial effect on the function of the corpus cavernosum.

• Applied Biosystems Group, of Foster City, Calif., reported the introduction of the Applied Biosystems 9800 Fast PCR System. The system delivers PCR results in a standard 96-well plate in about 25 minutes, compared with about two hours for conventional systems, the company said. The system will be on exhibit at the American Society of Human Genetics annual meeting in Toronto held Oct. 26-30.

• Benitec Ltd., of Queensland, Australia, gained an exclusive license from Stanford University in Palo Alto, Calif., to use the Minicircle DNA technology developed at the school for all RNAi therapeutic uses, with sublicensing rights. Using the technology, researchers have demonstrated therapeutic levels of transgene product in animal models for up to 10 months, with no toxicity from the non-integrating vector. Financial terms were not disclosed.

• Biophage Pharma Inc., of Montreal, received an undisclosed contribution from the Canadian government through the Canadian International Development Agency to open the Brazilian market to Biophage's therapeutic and diagnostic products.

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., presented an update on its calcium phosphate nanotechnology in vaccine development, including a vaccine for anthrax, at the annual World Vaccine Congress in Lyon, France on Oct. 11.

• Cambrex Corp., of East Rutherford, N.J., and Ortec International Inc., of New York, entered a multiyear agreement for Cambrex to market and distribute Orcel, a bioactive wound-care product, to treat chronic and acute wounds such as venous leg ulcers, diabetic foot ulcers and donor-site wounds in burn patients. The companies have an existing agreement in which Cambrex is the exclusive manufacturer of Orcel. Under the new agreement, Cambrex will provide a dedicated sales force, a multimillion-dollar product launch and will manage the entire sales and distribution process in the U.S. Cambrex also will provide an ongoing annual marketing commitment.

• Chiron Corp., of Emeryville, Calif., said it regrets that it is unable to meet the public health needs for the current influenza season and added that it is committed to resolving concerns raised by regulatory authorities in the UK and U.S. The company also said it intends to take action at its Liverpool facility in the UK so that it might fulfill its commitment to providing a reliable supply of Fluvirin influenza virus vaccine. Its pledge came simultaneous with news of the resignation of one of its board members, Richard Wills. Two weeks ago, Chiron said regulatory officials in the UK suspended its license to manufacture the flu vaccine, causing the U.S. to lose almost half its estimated supply for this flu season. (See BioWorld Today, Oct. 6, 2004.)

• Crucell NV, of Leiden, the Netherlands, agreed to license its PER.C6 technology to Merial Ltd., of Duluth, Ga., for the development and commercialization of veterinary vaccines for foot-and-mouth disease. In return, Crucell will receive an up-front payment, milestone payments, annual maintenance fees and royalties on sales of vaccines. Further financial details were not disclosed.

• Dynavax Technologies Corp., of Berkeley, Calif., established a collaboration with the Riken Institute in Tokyo for the development of cedar tree allergy therapeutics using the company's immunostimulatory sequence (ISS)-based therapeutics platform. Terms of the two-year collaboration call for Dynavax to apply its know-how in the discovery and development of ISS-based allergy therapeutics and develop a cedar antigen-ISS conjugate product. The institute will further test such therapeutic candidates in animal models of cedar pollinosis. Financial terms were not disclosed.

• Eisai Co. Ltd., of Tokyo, signed a three-year use and propagation license for MultiCell hepatocytes with Nosan Corp., an exclusive sub-licensee in Japan of XenoTech LLC, the licensee for hepatocyte cell lines from MultiCell Technologies Inc., of Warwick, R.I. The contract allows Eisai to use Fa2N-4 hepatocytes for internal testing purposes at one site. Financial terms were not disclosed.

• Elan Corp. plc, of Dublin, Ireland, said it is not in merger or business combination negotiations or discussions with Biogen Idec Inc., of Cambridge, Mass. The company, which is focused on neurodegenerative diseases, autoimmune diseases and severe pain, made its statement in response to a specific Irish Stock Exchange query.

• ES Cell International Pte. Ltd., of Singapore, said the National Institutes of Health in Bethesda, Md., granted the company a resource infrastructure enhancement award for human embryonic stem cell (hESC) research. It provides funding support over the next three years and will be used to continue research activities into the growth, expansion and characterization of hESCs, as well as for testing, quality assurance and distribution of ESI's hESCs that are listed on the NIH Human Embryonic Stem Cell Registry.

• GNI Ltd., of Tokyo, entered two license agreements with the University of Cambridge in the UK. The agreements grant exclusive rights to intellectual property related to targets for Cambridge's angiogenesis and inflammation research, which includes new drug targets for a number of diseases.

• GTC Biotherapeutics Inc., of Framingham, Mass., signed a two-year Cooperative Research and Development Agreement with the U.S. Army Medical Research Institute of Infectious Diseases to evaluate the potential therapeutic application of ATryn to hemorrhagic diseases resulting from infections of the Ebola and Marburg viruses. GTC will supply the product, its recombinant form of human antithrombin, for in vitro and preclinical studies developed by the institute, which will perform all work associated with the live viruses.

• Hemispherx Biopharma Inc., of Philadelphia, reported updated data from its recently completed pivotal Phase III trial of Ampligen vs. placebo in chronic fatigue syndrome (CFS). The randomized, double-blinded trial demonstrated medically and statistically significant increases in the primary endpoint, exercise treadmill duration, compared to placebo after a 40-week period. The company reported those findings earlier this year. More specific data showed that patients receiving Ampligen improved exercise treadmill performance 19.3 percent vs. 4.1 percent in the placebo group (p=0.037, analysis of covariance with baseline as covariate). The difference in improvement in exercise treadmill duration in the Ampligen cohort compared to placebo was 15.2 percent and more than twice the minimum considered medically significant (6.5 percent). (See BioWorld Today, May 4, 2004.)

• Hypnion Inc., of Lexington, Mass., relocated its corporate headquarters into more than 33,600 square feet in Lexington after moving out of Worcester, Mass. The neuroscience drug discovery company is focused on sleep-wake neurobiology and drug development.

• ILEX Oncology Inc., of San Antonio, and Berlex Inc., of Montville, N.J., said the FDA approved the use of Campath (alemtuzumab for injection) in a single-dose vial. The new formulation will be three times more concentrated than the marketed ampoule, and the companies called the new vial more convenient because no filtering is required during preparation. Following the single-dose vial launch, expected in December, the ampoule will remain available for a short time, after which only the vial will be available.

• NeoPharm Inc., of Lake Forest, Ill., continues to have its management questioned by its former chairman, John Kapoor. He said a recently released proxy analysis by Institutional Shareholder Services recommended that clients holding NeoPharm shares support his efforts and consent to removing four incumbent directors and replace them with his three nominees. Institutional Shareholder Services also recommended in favor of the other proposals set forth in Kapoor's consent solicitation. He entered a bid to change the drug development company's direction last month. (See BioWorld Today, Sept. 7, 2004.)

• Osmotics Corp., of Denver, entered a worldwide exclusive licensing agreement with Brigham Young University to acquire rights to a family of compounds and methods for treating antibiotic-resistant bacterial infections. Called cationic steroid antibiotics, the company said they act as antibiotics against Gram-negative and Gram-positive bacteria, and can be used alone or with conventional antibiotics. Also, in vitro testing has shown them to be effective at low concentrations against multidrug-resistant strains of Pseudomonas aeruginosa, salmonella and other bacteria. Financial terms of the license were not disclosed.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., said that Aeres Biomedical Ltd., of London, completed the humanization of its 3G4 antibody that recognizes the phospholipid phosphatidylserine. The 3G4 antibody is part of Peregrine's AntiPhospholipid Therapy platform technology.

• Prana Biotechnology Ltd., of Melbourne, Australia, said it plans to begin a Phase II/III study to examine the effect of PBT-1 (clioquinol) in moderate to severe Alzheimer's disease patients in the late first quarter or the second quarter of next year. The study, to be called PLACQUE (Progression Limiting in Alzheimer's: Clioquinol's Efficacy), will include 435 patients in the UK, Australia and South Africa. Patients will be treated for 52 weeks after being randomized into placebo and two treatment arms (125 mg and 250 mg BID). The company expects results to be available no sooner than late 2006, but expects to provide updates as the trial progresses. In related news, Prana said findings published in the Sept. 30, 2004, edition of the Journal of Biological Chemistry support its theory that PBT-1 slows the progression of Alzheimer's disease.

• Sunesis Pharmaceuticals Inc., of South San Francisco, began the second of two Phase I studies of SNS-595, its small-molecule drug. SNS-595 is a first-in-class cell-cycle modulator designed to kill proliferating cancer cells by inducing apoptosis. The Phase I trial is designed to examine weekly dosing regimens of SNS-595 for safety, tolerability and pharmacokinetics. In June, Sunesis began the first Phase I single-dose, dose-escalation study of SNS-595. That trial continues to enroll patients.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., said preliminary Phase IIa results reported at the European Society of Cardiology's Acute Cardiac Care Symposium in Rome indicate that VX-702 met pre-established safety and pharmacokinetic objectives in treating acute coronary syndrome patients undergoing percutaneous coronary intervention such as stent placement. In addition, the oral p38 MAP kinase inhibitor significantly reduced serum levels of the inflammatory biomarker C-reactive protein (CRP) in patients undergoing percutaneous coronary intervention, and CRP remained significantly lowered out to four weeks beyond the five-day dosing period.

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