• Aastrom Biosciences Inc., of Ann Arbor, Mich., said it completed the patient accrual and treatment portion of its U.S. Phase I/II multicenter long bone fracture trial using its cell-based Tissue Repair Cells (TRCs) for tissue regeneration on all 36 patients enrolled. The trial is evaluating the use of TRCs - a mixture of stem, stromal and progenitor cells derived from the patient's bone marrow - in the treatment of severe fractures that have failed prior treatment interventions.

• Acologix Inc., of Hayward, Calif., presented Phase II study data of AC-100, a synthetic peptide derived from an endogenous human protein produced by bone and dental cells, at the annual meeting of the International Association for Dental Research in Brisbane, Australia. The data demonstrated that AC-100 stimulated the formation of new dentin when applied to tooth defects.

• BioAlliance Pharma SA, of Paris, presented preliminary results from its Doxorubicin Transdrug Phase I/II trial for primary liver cancer, at the 12th International Symposium on Viral Hepatitis and Liver Disease in Paris. The trial involved 20 patients and the maximum tolerated dose was determined to be 30 mg/m2. The company plans to enter a Phase II/III trial in the third quarter.

• DeCode Genetics Inc., of Reykjavik, Iceland, submitted an investigational new drug application to the FDA for DG051, a compound to prevent heart attack. The company expects to begin Phase I testing later this summer. DG051 is a small-molecule inhibitor of leukotriene A4 hydrolase.

• Dendreon Corp., of Seattle, disclosed publication of results of a pivotal Phase III study (D9901) of Provenge, in the July issue of the Journal of Clinical Oncology. Provenge is an investigational active cellular immunotherapy for men with advanced androgen-independent prostate cancer. Data showed a significant survival advantage and a favorable safety profile. Dendreon is planning to submit a biologics license application to the FDA later this year.

• Karo Bio AB, of Huddinge, Sweden, completed a bioequivalence study of a new formulation of KB2115, a dyslipidemia drug, which consists of enteric coated tablets, suitable for once-a-day dosing. A Phase II program is planned for the fall.

• New River Pharmaceuticals, of Radford, Va., submitted an investigational new drug application to the FDA for NRP409, a Carrierwave triiodothyronine hormone, as a treatment for patients with primary hypothyroidism. Enrollment is expected to begin by the third quarter. New River also is evaluating whether to exercise its option to co-promote NRP104 with Shire plc, of Basingstoke, UK. NRP104 is under review with the FDA as a potential treatment for pediatric attention deficit/hyperactivity disorder. If the company exercises that option, it expects to field about 100 sales representatives in the first half of 2007.

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