• Aastrom Biosciences Inc., of Ann Arbor, Mich., and its wholly owned subsidiary, Zellera AG, of Berlin, said it began a clinical bone graft study in collaboration with BG-Kliniken "Bergmannsheil" Ruhr-University in Bochum, Germany. The study will use Aastrom's bone-forming TRCs in combination with a commercial synthetic bone graft matrix provided through collaboration with Mathys Medical, a division of Synthes in Bettlach, Switzerland, to treat patients with serious leg fractures that require a bone graft for recovery.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., entered a licensing agreement with Cold Spring Harbor Laboratory for intellectual property related to the induction of gene silencing in mammalian cells through RNAi. Alnylam received a nonexclusive license to therapeutic uses of patent applications and related technology stemming from RNAi research conducted at the laboratory. The intellectual property encompasses certain aspects of gene silencing in mammalian cells by small intefering RNA molecules, the natural mechanism expected to be harnessed by RNAi therapeutics.

• AmpliMed Corp., of Tucson, Ariz., appointed Robert Ashley chairman, CEO and president effective Jan. 1. Previously the senior vice president of commercial development at CollaGenex Pharmaceuticals Inc., Ashley began his career with Amersham International plc. AmpliMed is focused on the clinical development of chemotherapeutic agents for cancer.

• Astralis Ltd., of Fairfield, N.J., completed patient enrollment in its blinded Phase I trial of its lead product, Psoraxine, a new biological treatment for psoriasis. Twenty patients at two clinical sites were enrolled, and no clinically significant adverse effects related to Psoraxine have been reported so far. Full analysis is expected following its completion. The study was designed to evaluate the safety of a single dose of Psoraxine in patients with stable, moderate psoriasis that covers between 3 percent and 15 percent of the body surface.

• Biogen Idec Inc., of Cambridge, Mass., said Zevalin (ibritumomab tiuxetan) radioimmunotherapy received European approval for adult patients with CD20+ follicular B-cell non-Hodgkin's lymphoma who are refractory to or have relapsed following therapy with Rituxan (rituximab, Genentech Inc.). The FDA approved the product almost two years ago, and it is marketed and distributed by Biogen Idec in the U.S. Biogen Idec's overseas partner, Schering AG, of Berlin, expects to launch the product in Europe within the next few months. (See BioWorld Today, Feb. 21, 2002.)

• Cepheid Inc., of Sunnyvale, Calif., filed a registration statement with the SEC for a public offering of 5 million shares of common stock. The statement also covers an underwriters' overallotment option for another 750,000 shares. UBS Securities LLC will act as the sole book-running manager. Co-managers will be William Blair & Co. LLC; C.E. Unterberg, Towbin; and Rodman & Renshaw LLC. The company plans to use any proceeds for general corporate purposes, including working capital, research and development, and obtaining licenses.

• Eksigent Technologies LLC, of Livermore, Calif., released its NanoLC-2D Proteomics System, a high-performance liquid chromatography (HPLC) system that incorporates fully automated 2-dimensional HPLC separations with a direct-pumping nanoscale HPLC system.

• Elan Corp. plc, of Dublin, Ireland, will receive $70 million in proceeds from the sale of four properties and businesses, which include Elan's San Diego office property, a manufacturing and research and development business based in Mezzovico, Switzerland, and its Segix Italia manufacturing business in Pomezia, Italy. Proceeds also came from a multiyear rental agreement with the new owner of the San Diego facility, and from the receipt of a $25 million milestone payment as part of a deal between Elan and King Pharmaceuticals Inc., of Bristol, Tenn., that was contingent upon ongoing patent exclusivity for Skelaxin. Separately, Elan said its NanoSystems drug delivery business unit licensed its NanoCrystal technology to Aventis Pharma SA, a subsidiary of Aventis SA, of Strasbourg, France. In exchange for access and the right to develop and commercialize pharmaceuticals using the technology, Aventis will pay for formulation services, technology transfer, development milestones and royalties on sales of products incorporating or made using the technology.

• Endovasc Inc., of Montgomery, Texas, said Liprostin was shipped to Moscow to be used in the company's multicenter Phase II trial for patients suffering from peripheral vascular disease. Four clinical sites have begun screening patients suffering from the disease, including critical limb ischemia and intermittent claudication, who do not require angioplasty.

• EntreMed Inc., of Rockville, Md., said it identified a peptide fragment of tissue factor pathway inhibitor (TFPI), a naturally occurring anti-coagulant protein that blocks tumor growth and angiogenesis in in vivo models. While the peptide inhibits metastatic tumor and blood vessel growth, it does not appear to affect normal blood clotting. Company scientists also identified the TFPI peptide's mechanism of action. EntreMed said it is using the peptide as a template to design small molecules with similar, but improved, properties.

• GeneSeek Inc., of Lincoln, Neb., received an exclusive contract from A2 Corp. Ltd., of New Zealand, to provide the DNA genotyping necessary for production of A2 milk in the North American market. The product is essentially free of the protein beta-casein A1, which is found at varying levels in all cow milk sold in the U.S. and has been linked to certain health risks. GeneSeek will provide high-throughput DNA analysis to genotype dairy cattle for the beta-casein gene. Financial terms were not disclosed.

• Labopharm Inc., of Laval, Quebec, said its wholly owned Labopharm Europe Ltd. subsidiary opened its new head office in Dublin, Ireland. The company is nearing commercialization of its first product, a once-daily formulation of the analgesic tramadol, while in Europe, the product is available in generic immediate-release formulations that require dosing up to six times daily and branded sustained-release formulations that require twice-daily dosing.

• Lorus Therapeutics Inc., of Toronto, plans to present an abstract on Virulizin at this weekend's American Society of Clinical Oncology Gastrointestinal Cancers Symposium in San Francisco. The findings extend previous data, identifying natural killer cells as participants in Virulizin's mechanism of action. The studies were conducted in a collaboration between Lorus scientists and McGill University researchers.

• Maxim Pharmaceuticals Inc., of San Diego, said its scientists discovered a series of small molecules as inhibitors of the severe acute respiratory syndrome coronavirus. Those compounds, designated the MX128533 series, have been tested for antimicrobial activity by the National Institute of Allergy and Infectious Diseases in Bethesda, Md., at the Institute for Antiviral Research. The lead compound within the series demonstrated inhibition of the SARS-CoV in cell culture at very low concentrations (0.02 [mu]g/mL).

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., said a European regulatory committee issued a positive opinion to recommend approval under exceptional circumstances for Velcade (bortezomib) for multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on their last therapy. Velcade's European application was submitted in January 2003 and it was accepted for review a month later. The company added that it expects the final authority to ratify the opinion and issue an approval next quarter. Ortho Biotech and Janssen-Cilag, both units of Johnson & Johnson, of New Brunswick, N.J., will commercialize the product outside the U.S., and Millennium will receive royalties on such sales.

• NeoStrata Co. Inc., of Princeton, N.J., signed an agreement with Berlex Inc., the U.S. affiliate of Schering AG, of Berlin, for the formulation development of pharmaceuticals using NeoStrata technologies. Such technologies include advanced alpha-hydroxyacid and polyhydroxy acid formulations, which have been used to alleviate scaling associated with the disfiguring skin condition ichthyosis. Financial terms were not disclosed.

• Neurochem Inc., of Montreal, reported positive interim data on Alzhemed in the cognitive function of 30 patients with mild to moderate Alzheimer's disease. The results relate to patients who have completed both the three-month Phase II trial and an additional nine months of treatment in the open-label Phase II extension study.

• Novartis AG, of Basel, Switzerland, said its seven-year-old Novartis Venture Fund committed $35 million in 2003 through additional funding to 25 companies already in its portfolio and eight new businesses. The fund, with a 74-company portfolio, has invested $215 million since its inception.

• Oracle Corp., of Redwood Shores, Calif., said it acquired the assets of SiteWorks Solutions, a privately held supplier of clinical trial management software products that hospitals, pharmaceutical companies and research institutions use to manage clinical trials. Financial terms were not disclosed.

• RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., provided an exclusive license to certain European rights to its lead chronic wound therapy, Thymosin beta 4 (TB4), to Defiante Farmaceutica Lda, a wholly owned subsidiary of Sigma-Tau Group, of Rome. Defiante will pay RegeneRx a royalty on commercial sales and will purchase all required TB4 from the company. Should RegeneRx complete positive Phase II trials in the U.S., Defiante must either pay $5 million or begin Phase III trials in Europe to maintain the license. Defiante also will be obligated to attain future clinical and regulatory milestones in the licensed territory. As those milestones are obtained, certain performance criteria regarding commercial registration and minimum annual royalties will be required in each licensed country. The agreement does not prevent RegeneRx from sublicensing the technology in countries outside the licensed territory and has no impact on any U.S. rights.

• Royalty Pharma, of New York, acquired a portion of New York-based Memorial Sloan-Kettering Cancer Center's U.S. royalty interest in Neupogen and Neulasta, made by Amgen Inc., of Thousand Oaks, Calif. Memorial Sloan received $263 million in cash up front, plus certain additional payments if Neupogen and Neulasta's annual sales exceed certain levels. In addition, Memorial Sloan made a $7 million investment in Royalty Pharma. Neupogen is indicated in cancer patients receiving myelosuppressive chemotherapy; those with acute myeloid leukemia receiving induction or consolidation chemotherapy; those receiving bone marrow transplant; those undergoing peripheral blood progenitor-cell collection and therapy; and patients with severe chronic neutropenia. Neulasta is a long-lasting version of Neupogen.

• Seattle Genetics Inc., of Bothell, Wash., began a Phase II trial of SGN-30 to evaluate the antitumor activity and safety of the monoclonal antibody in patients with Hodgkin's disease or anaplastic large-cell lymphoma. The single-agent, open-label study will accrue up to 80 patients - 40 per disease indication. The trial is designed to assess the tolerability and antitumor activity of SGN-30 in patients who have relapsed or are refractory to prior therapies.

• Sequenom Inc., of San Diego, entered a pathogen-analysis research collaboration with the Health Protection Agency in London to apply Sequenom's MassArray technology in the genetic identification and differentiation of microbes, including major human pathogens such as Neisseria meningitides. The goal of the collaboration is to discover and develop genetic markers that differentiate pathogenic from nonpathogenic strains of those microbes.

• Syrrx Inc., of San Diego, said it selected three dipeptidyl peptidase IV (DP4) preclinical candidates, and simultaneously reported the publication of the atomic structure of DP4 in next month's issue of ProteinScience. DP4 inhibitors are being investigated in advanced clinical trials for the potential treatment of Type II diabetes, and studies to date indicate that it plays a role in regulating insulin levels in the body. The three selected preclinical candidates formed part of the basis for a collaboration between Syrrx and PPD Inc., of Wilmington, N.C., that was announced two months ago. As part of the agreement, PPD made a $25 million equity investment in Syrrx convertible preferred stock and agreed to fund the majority of preclinical and clinical studies through Phase IIb. (See BioWorld Today, Nov. 21, 2003.)

• XOMA Ltd., of Berkeley, Calif., began a Phase II trial with its XMP.629 peptide, which is being developed as a topical treatment for acne. In several preclinical studies, XMP.629 was found to be active against Propionibacterium acnes and other related skin microorganisms associated with acne, demonstrating favorable topical properties, safety and rapid bactericidal activity. Phase I studies also have shown favorable properties in terms of skin irritation and penetration. The Phase II trial is a randomized, double-blinded, placebo-controlled, dose-ranging efficacy and safety study of 240 patients with mild to moderate acne.