¿ Biocompatibles International plc, of Surrey, UK, and British Biotech plc, of Oxford, UK, began trials of the Batimastat BiodivYsio stent, a drug-coated device designed to reduce restenosis in patients who have undergone coronary angioplasty. The multicenter trial is evaluating 150 patients for safety and efficacy, which will be measured by angiographic restenosis at six months following deployment of the device.
¿ Cellegy Pharmaceuticals Inc., of South San Francisco, and PanGeo Pharma Inc., of Montreal, signed a long-term agreement under which PanGeo will manufacture Cellegy¿s Tostrex testosterone gel at its Montreal plant. Under the agreement, Cellegy will supply PanGeo with Tostrex over a five-year period following final approval from the FDA. Tostrex, a treatment for male hypogonadism, is undergoing Phase III trials.
¿ Chrysalis Biotechnology Inc., of Galveston, Texas, completed its analysis of a pilot Phase I/II trial of its drug Chrysalin for the treatment of diabetic ulcers. Chrysalis conducted a four-center, randomized, double-blind study to evaluate the safety and preliminary efficacy of Chrysalin in 59 patients with chronic diabetic ulcers. The primary objective of the study was to evaluate the safety of topically applied Chrysalin, and the results showed the drug appeared to be well tolerated, with no drug-related adverse effects.
¿ CV Therapeutics Inc., of Palo Alto, Calif., began Phase II trials of CVT-3146, a selective, short-acting A2A adenosine receptor agonist that is being developed to selectively increase coronary artery flow for the potential use as an adjunctive pharmacological agent in cardiac perfusion imaging studies. The purpose of the trials is to determine the tolerability of CVT-3146 and its effect on coronary blood flow in patients undergoing a clinically indicated cardiac catheterization.
¿ Evotec OAI, of Hamburg, Germany, signed a four-year contract with Pharmacia Corp., of Peapack, N.J., under which Evotec will provide high-quality libraries for pharmaceutical screening and receive program and milestone fees on any product that comes out of the collaboration. The contract is an extension of an original agreement signed by Evotec, a supplier of integrated high-value added drug discovery services, and the pharmaceutical company in 1998.
¿ InterMune Inc., of Brisbane, Calif., completed enrollment in its Phase III trials evaluating the safety and efficacy of Actimmune for the treatment of idiopathic pulmonary fibrosis (IPF), a life-threatening disease characterized by progressive scarring or fibrosis of the lungs. The company said Actimmune showed promise in treating IPF in Phase II trials.
¿ MBT Munich Biotechnology GmbH, of Munich, Germany, completed a EUR$30.3 million (US$$27.8 million) self-managed private placement led by Heidelberg Innovation. Co-investors were Deutsche Bank, Sal. Oppenheim, Deutsche Effecten, Hypo-Vereinsbank and Global Vision. Existing investors who also supported the financing round include 3i, tbg and Global Life Science. The total private funds raised by the company increased to EUR38 million since its inception in September 2000. The company¿s technology focuses on specific delivery of compounds to angiogenic endothelial cells to treat tumors.
¿ MGI Pharma Inc., of Minneapolis, and MethylGene Inc., of Montreal, began Phase II trials of MG98 in patients with advanced and/or metastatic renal cell carcinoma. The trials will judge the efficacy of MG98 when given as a two-hour intravenous infusion twice a week in three out of every four weeks. The primary endpoint of the trial is tumor response. MG98 is a second-generation antisense inhibitor of DNA methyltransferase.
¿ MorphoSys AG, of Martinsried, Germany, said it won a preliminary ruling in its patent dispute with Cambridge Antibody Technology plc (CAT), of Melbourn, UK, regarding the Griffiths U.S. patent (No. 5,885,793). A U.S. District Court in Washington, D.C., issued a preliminary ruling stating MorphoSys should prevail on the issue of infringement, pending further developments. The focus was on whether MorphoSys¿ HuCAL antibody libraries are derived from humans. CAT pointed out that the judge found for it on four of MorphoSys¿ invalidity assertions and did not rule on the fifth. Separately, MorphoSys said a court in San Diego granted its motion to dismiss a second attempt by CAT and others to bring a suit alleging infringement of the Winter II U.S. patent (No. 6,248,516).
¿ Seattle Genetics Inc., of Bothell, Wash., began Phase II trials of SGN-15, its monoclonal antibody drug conjugate designed for patients with non-small-cell lung cancer. The trials will evaluate SGN-15¿s efficacy in combination with the chemotherapeutic drug Taxotere against Taxotere alone. The randomized trial is expected to enroll up to 60 patients. This is the fourth potential indication for SGN-15, which is already undergoing trials in breast, colon and prostate cancers.
¿ Third Wave Technologies, of Madison, Wis., along with scientists from Northwestern University and the University of Wisconsin/Madison, successfully applied Third Wave¿s Invader technology to a microarray platform, according to findings published in the current issue of Nucleic Acids Research Methods Online. A microarray contains thousands of unique genetic variation analysis targets at discrete sites on a solid surface or support, like microscopic latex beads or a small glass or plastic chip. The findings hold promise for genotyping and gene expression analysis applications.
¿ Virax Holdings Ltd., of Melbourne, Australia, entered into a collaboration with Michael Brown of Royal Adelaide Hospital¿s Cancer Center to develop leads for an immune-based therapy to treat prostate cancer. The therapeutic vaccine to be developed under the agreement will use Virax¿s platform technology, Co-X-Gene in FPV (fowlpox virus) vector. Virax is currently conducting a Phase I/IIa trial testing Co-X-Gene in FPV for the treatment of HIV.