• Aastrom Biosciences Inc., of Ann Arbor, Mich., received a $110,062 Phase I Small Business Innovation Research grant from the National Institutes of Health in Bethesda, Md. The grant will be used to support investigations to expand the company's development of stem cell-based approaches for regeneration of bone in patients requiring a bone graft treatment. The study will seek to further optimize Aastrom's technology for producing its line of Tissue Repair Cells, which are mixtures of stem and other cells produced from a sample of the patient's own bone marrow.

• Affymetrix Inc., of Santa Clara, Calif., released the GeneChip-brand Barley Genome Array, the first commercially available barley microarray. Created through a worldwide collaboration of barley researchers, the microarray contains more than 22,700 sequences, including more than 1,000 genes from the National Center for Biotechnology Information database, as well as more than 20,000 barley genes identified from partial cDNA sequences.

• Akers Biosciences Inc., of Thorofare, N.J., formed an alliance with The Medicines Co., of Parsippany, N.J., to increase awareness of and to market Akers' Rapid Heparin-Platelet Factor-4 (HPF-4) antibody test once it receives regulatory approval. The test, currently in clinical development, is designed to identify patients at risk for developing heparin-induced thrombocytopenia and thrombosis syndrome, an allergic-like side effect associated with the use of the anticoagulant heparin.

• Applied DNA Sciences Inc., of Los Angeles, and Harriet & Henderson Yarns Inc., of Henderson, N.C., a producer of cotton open-end spun yarns, formed an alliance to conduct trials of Applied DNA's DNA-embedded textile marker system for use by both U.S. textile manufacturers and the U.S. Customs Service. Applied DNA said it believes that the potential U.S. market for its marker system in the cotton segment of the textile industry could exceed $80 million annually.

• Australian Cancer Technology, of West Perth, Australia, said as its anticancer vaccine, Pentrix, moves into the next stage of clinical trials, that the Centre for Developmental Cancer Therapeutics (CDCT) in Melbourne will conduct a Phase II trial of the vaccine in 40 patients with hormone-refractory prostate cancer. The CDCT is a formal collaboration between six Melbourne institutions and Clinical Trials Victoria, a government effort to attract more clinical trials to Victoria. The trial is scheduled to begin in October.

• The Biotechnology Industry Organization in Washington said it supports traceability and labeling laws concerning biotech-improved foods it said the European Parliament approved, but added that such standards would be impractical. BIO said the rules actually might preclude European consumers from such foods, as manufacturers could re-formulate their offerings to shun biotech-derived ingredients in order to avoid the new regulations. BIO acknowledged that the Parliament's intent is to provide European Union consumers the opportunity to choose biotechnology-improved foods and to enable its politicians to end the moratorium on approvals of biotech-derived products that has been in place for more than four years. The National Corn Growers Association decried the Parliament's decision, calling the vote "disappointing and a step in the wrong direction."

• Bruker Daltonics Inc., of Billerica, Mass., and Bruker AXS Inc., of Madison, Wis., completed the merger of the two companies in a deal valued at $103.6 million, which was approved by stockholders on June 27. The combined company was named Bruker BioSciences Corp. and began trading under the Nasdaq ticker symbol "BRKR" at market's open Wednesday. Bruker BioSciences has formed two operating subsidiaries, Bruker AXS Inc. and Bruker Daltonics Inc., into which it transferred substantially all of the assets and liabilities, except cash, which formerly belonged to the respective companies. Bruker Daltonics is a developer and provider of life sciences tools based on mass spectrometry. Bruker AXS develops and provides materials research tools based on X-ray technology.

• Celgene Corp., of Warren, N.J., began a pivotal trial of Focalin LA (dexmethylphenidate hydrochloride extended-release capsules) in adults with attention deficit disorder/attention deficit hyperactivity disorder. Novartis Pharmaceuticals Corp., a division of Novartis AG, of Basel, Switzerland, has marketing rights in the U.S. and will conduct the multicenter, controlled trial to evaluate Focalin LA given once daily. Focalin is approved for the treatment of ADD/ADHD in children and adolescents. Focalin LA, an extended-release version, is intended to be dosed once daily. (See BioWorld Today, Nov. 16, 2001.)

• CeNeS Pharmaceuticals plc, of Cambridge, UK, finalized plans for the Phase III trials of M6G (morphine-6-glucuronide) for the treatment of postoperative pain and the early Phase II trials of CNS 5161, its compound for neuropathic pain. The M6G Phase III trial is expected to be complete in mid-2004. The trial will seek to recruit 168 patients with postoperative pain following knee surgery in three European countries. The main objective will be to compare the analgesic efficacy and duration of action of a range of doses of M6G given intravenously, compared with placebo. A second Phase III trial also is planned. Separately, the company said its board resolved to apply for the company's shares to be admitted to the Alternative Investment market of the London Stock Exchange. CeNeS will cancel its listing on the official London Stock Exchange.

• Connetics Corp., of Palo Alto, Calif., submitted a new drug application to the FDA for Extina, a formulation of 2 percent ketoconazole formulated with the company's platform foam delivery vehicles, for seborrheic dermatitis. Ketoconazole also is used to treat a variety of other fungal infections.

• Cubist Pharmaceuticals Inc., of Lexington, Mass., purchased from Eli Lilly & Co., of Indianapolis, a reduction in the royalties payable to Lilly on net sales of Cubist's antibiotic, Cidecin (daptomycin for injection), should it gain regulatory approval. Cubist acquired worldwide development and commercialization rights to daptomycin from Lilly in 1997. Cubist will issue to Lilly $8 million in stock, with registration rights. The price of the shares will be determined based on the average closing price of the stock over 20 consecutive trading days ending July 18. In exchange for the shares, Cubist's global royalty obligation to Lilly on Cidecin sales will be reduced by 1 percent. The new drug application for Cidecin is under review. (See BioWorld Today, Dec. 23, 2002.)

• Forbes Medi-Tech Inc., of Vancouver, British Columbia, will receive a $3 million advance payment from Phyto-Source LP, of Pasadena, Texas, its manufacturing joint venture with Chusei (USA) Inc., of Houston. The payment goes toward a $4 million loan made by Forbes Medi-Tech during the formation of the joint venture. On completion of the repayment to the Southwest Bank of Texas, the remaining $1 million will be paid to Forbes through future sales of Phyto-Source's sterol-based ingredients.

• Genaera Corp., of Plymouth Meeting, Pa., said that by mutual agreement on June 30, Genentech Inc., of South San Francisco, elected to convert its entire holdings of Genaera's Series A preferred stock, plus accrued but unpaid preferred dividends thereon, into Genaera common stock. Genentech, the sole holder of such shares issued in connection with a May 2000 research and development collaboration, converted 888 shares of Series A convertible preferred stock and accrued dividends of about $263,000 into 540,375 shares of newly issued Genaera common stock at a 5-day trailing average market price of $2.13. Upon the closing of the transaction, Genentech no longer will hold any shares of preferred stock in Genaera.

• GPN Network Inc., of Los Angeles, said it closed its acquisition of ImmuneRegen BioSciences Inc., of Scottsdale, Ariz., in a stock exchange. GPN plans to issue about 10.5 million common shares, following a 1-for-20 reverse split of GPN's common stock. The acquisition of ImmuneRegen, which is developing applications that use modified substance P, a naturally occurring immunomodulator, was structured as a merger.

• H3 Pharma Inc., of Montreal, and Debiopharm SA, of Lausanne, Switzerland, formed an agreement giving H3 Pharma the worldwide research, development and commercialization rights to Sanvar (vapreotide). Sanvar immediate-release formulation demonstrated in a clinical study the benefits of the early use of the product in the treatment of acute esophageal variceal bleeding, both in stopping acute hemorrhage prior to endoscopic intervention and in the prevention of recurring bleeding during the five days following treatment, H3 said. The product has completed a Phase III trial in Europe and has orphan drug status in the U.S.

• ICN Pharmaceuticals Inc., of Irvine, Calif., said it sold its research products and diagnostic businesses of its ICN Biomedicals division to MP Global Enterprises. The businesses sold were discontinued operations and the entire transaction was valued at $15 million, paid for in ICN shares. Separately, MP Biomedicals Inc., a privately held company owned by ICN founder and former CEO, Milan Panic, said it acquired all assets of ICN Biomedicals. Panic left ICN in 2002 but has remained a member of its board.

• ILEX Oncology Inc., of San Antonio, said it filed with the SEC a shelf registration statement for the proposed offering, from time to time, of up to $150 million of ILEX common stock. ILEX is an oncology drug development company and has Campath approved in the U.S. and Mabcampath in Europe.

• Magistral Biotech Inc., of Montreal, announced in March it planned to conduct a private placement worth $400,000 with iForum Securities Inc. Magistral has since pursued its discussions with iForum and agreed to proceed to a public offering of shares instead. Magistral said that June 20 it filed a preliminary prospectus with the Quebec Securities Commission in connection with the issuance of 3.5 million to 6 million units, each unit being composed of a common share and one-tenth of one warrant, each whole warrant enabling its holder to purchase a common share at a price of C45 cents (US34 cents) for a two-year period. Each unit will be offered at a price of C20 cents. iForum will act as agent for the offering. A first closing is due for the middle of July. Proceeds will be used to accelerate the costs incurred by Magistral's marketing efforts during 2003 regarding its products, it said. The company is focused on chitodextrin, an ingredient from natural sources that might reduce cholesterol levels.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., initiated a multicenter Phase II trial of Velcade in patients with relapsed or refractory mantle-cell lymphoma. The three-stage study will assess time to progression, response rate, duration of response and overall survival. The trial is being conducted at multiple sites in North America and the UK and is expected to enroll about 152 patients who have received one or two prior lines of therapy. Velcade was approved for multiple myeloma in May. (See BioWorld Today, May 15, 2003.)

• Neurochem Inc., of Montreal, said its clinical advisory board unanimously recommended that the company advance Alzhemed, its investigational candidate for Alzheimer's disease, into Phase III studies pending regulatory approval in the U.S., Canada and Europe. The board offered its endorsement after reviewing preliminary findings from a Phase II trial. Neurochem, which is listed on the Toronto Stock Exchange, said it is planning a U.S. listing at the same time as a major equity issue through an American and Canadian offering this fall to raise funds for Alzhemed's clinical trials.

• OxiGene Inc., of Watertown, Mass., said the Johns Hopkins University School of Medicine will begin a Phase I/II trial of the company's lead vascular targeting agent, Combretastatin A4 Prodrug. The study will be conducted in patients with a retinal degenerative disease known as wet age-related macular degeneration. About 20 patients are scheduled to participate.

• Precise Biometrics AB, of Lund, Sweden, implemented a new share issue with preferential rights for its shareholders. The issue was oversubscribed, which will lead to the company receiving SEK40.4 million (US$5 million) before expenses. The new share issue means that the number of Class A shares will increase by about 23.7 million and that after the issue the total number of shares will be about 35.6 million

• Pro-Pharmaceuticals Inc., of Newton, Mass., reported the publication of a preclinical study demonstrating the importance of the role its Universal Carbohydrate Linker technology might play in increasing the efficacy and decreasing the toxicity of chemotherapeutic drugs, possibly through the use of carbohydrate-specific receptors found on cancer cells. The article was published in the June 23, 2003, issue of Carbohydrate Research. Pro-Pharmaceutical focuses on commercializing anticancer treatments using carbohydrate molecules.

• Seattle Genetics Inc., of Bothell, Wash., said its stockholders approved a previously reported $41 million private placement of Series A convertible preferred stock and warrants, a transaction the company expects to close within five business days. The company will issue 1.64 million preferred shares, convertible into 16.4 million common shares, as well as warrants to purchase 2.05 million common shares. Seattle Genetics, which said the financing would increase its cash and investment balance to more than $70 million, said it would use portions of the funding to advance its antibody-based drug candidates. It plans to move SGN-30 into a Phase II trial, begin Phase I studies of SGN-40, advance Phase II studies of SGN-15 and accelerate the development of SGN-35, an antibody drug conjugate that employs its technology. JP Morgan Partners LLC and Baker Brothers Investments led the placement, with additional participation from Delphi Ventures and BA Venture Partners.

• Sequenom Inc., of San Diego, sold a MassArray system to the Genome Research Center at the University of Hong Kong for their contribution to the International HapMap Project, a $100 million public-private effort launched to construct a detailed map of genetic variation in the human genome.

• The Spondylitis Association of America in Sherman Oaks, Calif., along with collaborating researchers, forwarded a draft copy of the proposed "Ankylosing Spondylitis Guidance Document" to the FDA for review. The association and the Ankylosing Spondylitis Assessment Working Group spearheaded the project. The purpose of the document, when finalized by the FDA, is to guide physicians, researchers and companies developing therapies for ankylosing spondylitis and how to measure improvement or remission.

• University of Pittsburgh researchers completed the first survey of the entire human genome for genes that affect the susceptibility of individuals to developing clinical depression. Researchers located a number of chromosomal regions they say hold the genetic keys to a variety of mental illnesses, including major depression and certain addictions. The survey was done in 81 families identified by individuals with recurrent, early onset, major depressive disorder. The team's findings were published Wednesday in the American Journal of Medical Genetics.

• Valentis Inc., of Burlingame, Calif., said a paper on its angiogenesis gene, Del-1, was published in the July issue of Journal of Clinical Investigations. The company said most of the known pro-angiogenesis proteins are growth factors, which are soluble. It said Del-1 is stable, doesn't diffuse and has the potential ability to stimulate angiogenesis.