• BioMimetic Therapeutics Inc., of Franklin, Tenn., completed enrollment in its Canadian pilot study with its lead candidate, GEM OS1 Bone Graft. As a result of the preliminary data obtained, the company received authorization from the Canadian government to expand the study from 20 patients to up to 60. BioMimetic hopes to file for Canadian registration for orthopedic indications in 2007. The company also has completed enrollment in its U.S. pilot study for foot and ankle fusions and its Swedish pilot study to evaluate the treatment of distal radius fractures.

• Biopure Corp., of Cambridge, Mass., submitted a marketing authorization application to the UK's Medicines and Healthcare Products Regulatory Agency for Hemopure, its oxygen therapeutic. The company is seeking MHRA authorization to market the medicine in the UK to treat acutely anemic adult orthopedic surgery patients younger than 80 years old. The submission includes data from a 688-patient Phase III orthopedic surgery trial conducted in the U.S., South Africa, Europe and Canada, and from a 160-patient Phase III general non-cardiac surgery trial conducted in South Africa and Europe.

• Neose Technologies Inc., of Horsham, Pa., concluded the dosing and safety follow-up for its Phase I trial in Western Europe, showing NE-180 generally was well tolerated at the doses tested, and the expected increases in reticulocytes and hemoglobin were observed in both the intravenous and subcutaneous dose groups. The company continues to work with the FDA on its NE-180 clinical hold in the U.S. While initial concerns were addressed, the FDA raised questions with regard to the reliability of the existing potency assay as a measurement of product stability. Neose plans to address the questions during the next three quarters, and to begin a Phase II trial in Western Europe in the fourth quarter. NE-180 is being developed to treat chemotherapy-induced anemia and anemia associated with chronic renal failure.

• Oncolytics Biotech Inc., of Calgary, Alberta, began patient enrollment in its clinical trial of Reolysin to treat patients with recurrent malignant gliomas. The trial is an open-label, dose-escalation Phase I/II study in which a single dose of Reolysin is administered by infusion to patients with recurrent malignant gliomas that are refractory to standard therapy.

• Oramed Pharmaceuticals Inc., of Jerusalem, received approval to start Phase I studies in healthy volunteers of oral insulin in Israel. The company is developing an orally ingestible soft gel insulin capsule to treat diabetes, and it is pursuing the development of oral delivery solutions for other drugs and vaccines.

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