• Corcept Therapeutics Inc., of Menlo Park, Calif., started a Phase III trial of Corlux, its cortisol receptor antagonist, in endogenous Cushing's syndrome. The FDA indicated earlier this year that the 50-patient open-label study might provide a reasonable basis for a new drug application submission. Corlux previously received orphan drug designation for Cushing's, a disease caused by prolonged exposure of the body's tissues to high levels of cortisol.

• CuraGen Corp., of Branford, Conn., and TopoTarget AS, of Copenhagen, Denmark, started dosing in a Phase II trial of intravenous belinostat, a small-molecule histone deacetylase inhibitor, in patients with previously treated thymoma and thymic carcinoma. About 33 patients will be enrolled, and the study's primary objective is to determine the objective response rate using RECIST criteria. Secondary endpoints include time to response, duration of response, progression-free survival and overall survival. The trial is sponsored by the National Cancer Institute.

• GlobeImmune Inc., of Louisville, Colo., started a Phase II trial of its GI-5005 Tarmogen in chronic hepatitis C infection. The study is designed to evaluate the drug in combination with full duration standard of care (pegylated interferon plus ribavirin) vs. standard of care alone in about 120 patients with chronic genotype-1 HCV who are either treatment-naïve or nonresponders to previous therapy. Endpoints will include improvement in alanine aminotransferase (ALT), HCV RNA, early virologic response, end-of-treatment response, sustained virologic response, serum markers of liver fibrosis/necrosis and liver biopsy in a subset of patients. GI-5005, GlobeImmune's lead candidate from its Tarmogen active immunotherapy platform, is a whole, heat-killed recombinant yeast genetically modified to express HCV-specific protein targets.

• Javelin Pharmaceuticals Inc., of Cambridge, Mass., reported results from a Phase II study of intranasal ketamine in acute postoperative pain associated with molar extraction, showing that the drug, as in prior studies, demonstrated a rapid (less than 10 minutes) onset of pain relief, generally mild and transient adverse effects and had no changes in vital signs, oxygen saturation or the nasal mucosa and no significant dissociative psychological effects. Data showed that pain relief with the highest ketamine dose (50 mg) separated from placebo more than one hour, as well as more than three hours, over which time the lowest dose also was superior to placebo. Those results were published in the International Journal of Acute Pain Management.

• Kiadis Pharma BV, of Amsterdam, the Netherlands, said it successfully completed an end-of-Phase II meeting with the FDA for Reviroc, a product in development for eliminating cancer cells from autologous graft in bone marrow transplantations for end-stage blood cancer patients. The agency agreed that the data from the completed Phase II study is sufficient to support the start of a Phase III trial and offered Kiadis its special protocol assessment procedure to optimize the design of that trial. Kiadis anticipates filing the SPA request and orphan drug designation application for Reviroc within the next few weeks.

• Lipid Sciences Inc., of Pleasanton, Calif., concluded patient enrollment in its first HDL therapy trial, which is designed to randomize patients with acute coronary syndrome to receive either treatment, in the form of Lipid's Selective Delipidation System (PDS-2) or placebo. The FDA-approved protocol for the study called for a maximum of 30 patients, based on an expected drop-out rate of 33 percent, but the trial's 92 percent retention rate allowed the company to gather sufficient data with the current enrollment of 28 patients. Lipid said patients will have completed their scheduled plasma collection and re-infusion treatments by the end of January.

• Plethora Solutions Holdings plc, of London, received regulatory approval to start a Phase III study of PSD502 for premature ejaculation in Europe. The company previously started a Phase III program in the U.S. for PSD502, a formulation of two marketed drugs, lidocaine and prilocaine, dispensed by a metered-dose aerosol. Plethora licensed U.S. rights to the drug to Boston-based Sciele Pharma Inc., for that indication, while retaining co-promotion rights in the urologist market.

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