• Adventrx Pharmaceuticals Inc., of San Diego, completed enrollment of a targeted 32 patients in its single-arm, Phase II trial of ANX-510 (CoFactor) plus 5-fluorouracil (5-FU) for breast cancer. CoFactor is the active metabolite of leucovorin and is intended to boost the efficacy and decrease the toxicity of 5-FU. Data are expected in the second quarter of 2008. A Phase IIb trial in colorectal cancer missed its primary endpoint earlier this year, and a Phase III colorectal cancer trial with 5-FU and Avastin (bevacizumab, Genentech Inc.) was discontinued. Adventrx expects to have overall survival data from the failed Phase IIb trial and data from the discontinued Phase III trial by mid-2008. (See BioWorld Today, Oct. 2, 2007.)

• Genzyme Corp., of Cambridge, Mass., completed enrollment of a targeted 109 patients in a Phase II trial of Clolar (clofarabine) in previously untreated, older patients with acute myelogenous leukemia (AML). Data will be presented at the American Society of Clinical Oncology annual meeting in the spring of 2008. The company also is conducting a Phase III trial in relapsed or refractory adult AML patients. Clolar is approved for pediatric relapsed or refractory acute lymphocytic leukemia, and Genzyme plans to submit a supplemental new drug application in the second half of 2008 to expand the label into AML.

• Lexicon Pharmaceuticals Inc., of The Woodlands, Texas, initiated a Phase IIa European trial with LX6171 for cognitive impairment associated with disorders such as Alzheimer's disease, schizophrenia and vascular dementia. The trial will evaluate bioavailability, safety, tolerability and cognitive effects. Data are expected by the end of 2008. LX6171 inhibits a central nervous system membrane protein and is being developed through a collaboration with Symphony Capital Partners LP. (See BioWorld Today, June 19, 2007.)

• Metastatix Inc., of Atlanta, initiated a Phase I trial of the CXCR4 inhibitor MSX-122 in patients with advanced solid tumors. In preclinical studies, MSX-122 displayed a favorable pharmacodynamic and safety profile, while inhibiting the function of the CXCR4 chemokine receptor, and might have potential in several indications including various cancers and inflammatory diseases.

• Oculus Innovative Sciences Inc., of Petaluma, Calif., completed enrollment of a targeted 67 patients in its randomized, open-label, Phase II trial of Microcyn Technology for mildly infected diabetic foot ulcers. The trial is comparing the oxychlorine solution Microcyn to levofloxacin alone and to a combination of the two drugs. Preliminary data are expected in the first quarter of 2008.

• The Medicines Co. Inc., of Parsippany, N.J., said one-year results of its ACUITY (Acute Catheterization and Urgent Intervention Triage StrategY) trial showed that acute coronary syndrome patients treated with Angiomax (bivalirudin) alone had similar rates of ischemic clinical outcomes compared with a more complicated treatment regimen of heparin plus a glycoprotein IIb/IIIa inhibitor. Those findings, published in the Journal of the American Medical Association, confirmed previously published 30-day results, which showed similar ischemia at 30 days and nearly 50 percent fewer episodes of major bleeding. Angiomax is a direct thrombin inhibitor currently under regulatory review to expand its use to include emergency use in ACS patients.

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