• Abraxis BioScience Inc., of Los Angeles, will begin enrollment in two Phase I/II clinical trials to investigate the use of its nab-docetaxel (ABI-008), an albumin-bound chemotherapeutic for the treatment of hormone refractory prostate and metastatic breast cancer. Enrollment in the first study for hormone refractory prostate cancer is expected to begin in April, with the second Phase I/II trial in metastatic breast cancer starting in the second quarter of 2007. Both trials will be conducted at the University of Texas M. D. Anderson Cancer Center in Houston. Abraxis received FDA clearance for the nab-docetaxel investigational new drug application in January. Nab-docetaxel is the second drug based on the company's proprietary nanoparticle albumin-bound technology to enter clinical development. Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) was approved by the FDA for treating metastatic breast cancer in January 2005.

• Acambis plc, of Cambridge, UK, has begun clinical testing of its investigational West Nile virus vaccine, ChimeriVax, in older adults. The trial, being conducted in the U.S., is to evaluate the safety, tolerability and immunogenicity of the compound. The randomized, double-blind, placebo-controlled study is the second part of a Phase II trial evaluating the vaccine. The first part of the trial involved adults ages 18-40. It showed that more than 97 percent of subjects who received a single dose of ChimeriVax-West Nile developed neutralizing antibodies above the predefined cut-off level 28 days after vaccination. The majority of adverse events were mild in nature, the company said.

• Amicus Therapeutics, of Cranbury, N.J., announced that Phase I results of Plicera (isofagomine tartrate, AT2101) for Gaucher disease showed it was well tolerated and that oral administration resulted in a significant elevation of target enzyme levels in healthy volunteers. Based on those results, the company is planning two Phase II clinical trials. Plicera is designed to selectively bind to and stabilize GCase, the enzyme deficient in Gaucher disease. That deficiency leads to lysosomal accumulation of glucocerebroside inside certain cells, which is believed to cause the various symptoms of the disease. Plicera facilitates proper trafficking of the enzyme to the lysosomes, the compartments in the cell where it is needed to break down glucocerebroside. Details of the Phase I findings are scheduled for presentation at the American College of Medical Genetics annual meeting now under way in Nashville, Tenn.

• Encysive Pharmaceuticals Inc., of Houston, said the first patient has been enrolled in its Phase II dose-ranging study of oral TBC3711, a next-generation, highly selective endothelin receptor antagonist, in resistant hypertension. The 12-week, multicenter, randomized, double-blind study will evaluate four once-daily oral doses of TBC3711 vs. placebo in about 150 patients with diagnosed resistant hypertension. Primary outcome data will consist of blood pressure measurements taken pre-dose and two hours post-dose.

• Neose Technologies Inc., of Horsham, Pa., and BioGeneriX AG, of Mannheim, Germany, a member of the Ratiopharm Group of companies, initiated the second Phase I trial of GlycoPEG-GCSF, a long-acting granulocyte-colony stimulating factor. The trial in healthy volunteers will compare a subcutaneously administered fixed dose of GlycoPEG-GCSF vs. the approved fixed dose of Thousand Oaks, Calif.-based Amgen Inc.'s Neulasta. GlycoPEG-GCSF is being developed for the treatment of neutropenia associated with cancer chemotherapy. Interim results from the ongoing Phase I trial showed a dose-dependent response for GlycoPEG-GCSF vs. Neulasta, with no reported serious adverse events, Neose said.