• Arrow Therapeutics Ltd., of London, selected a hepatitis C clinical candidate and moved it into full preclinical development. Called A-831, the company said the compound has shown activity in the replicon assay, has a good therapeutic index and pharmacokinetic properties, and displays a new mechanism of action targeting the NS5a protein. Phase I trials are planned for the second half of the year, by which time another compound from Arrow's second hepatitis C program (also targeting the NS5a protein) is expected to enter preclinical development.

• Celtic Pharmaceutical Holdings LP, of Hamilton, Bermuda, and Neurobiological Technologies Inc., of Emeryville, Calif., began patient enrollment in the second of two Phase III trials of Xerecept (corticotropin-releasing factor) for peritumoral brain edema. The second pivotal study will compare the combination of dexamethasone and Xerecept in patients already on low-dose steroids whose dose must be escalated to treat symptoms. Once they complete the study, they can enter an open-label trial to continue receiving Xerecept. In November, Neurobiological Technologies sold the product's exclusive worldwide rights for $48 million to Celtic Pharma, and it provides contractual services surrounding the development. (See BioWorld Today, Sept. 21, 2005.)

• Chemokine Therapeutics Corp., of Vancouver, British Columbia, gained approval from Health Canada to initiate a Phase Ib/II trial using CTCE-9908, a chemokine CXCR4 antagonist. The company plans to test the drug in up to 30 patients with late-stage cancers to evaluate safety, as well as early efficacy. The trial is designed to study a mixed group of tumors that will include the most common cancers, such as ovarian, lung and breast.

• DOV Pharmaceutical Inc., of Hackensack, N.J., started dosing in a Phase II trial of bicifadine, its novel analgesic, in patients with painful diabetic peripheral neuropathy. The 50-patient trial is a randomized, multiple-dose, open-label, two-phase overlap trial designed to assess the efficacy and safety of bicifadine and potential interactions of bicifadine and oxycodone used concurrently. DOV expects to complete dosing in the third quarter.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., started a Phase II program with ISIS 301012 in patients with familial hypercholesterolemia, a genetic disorder that causes extremely high cholesterol levels and results in the early onset of heart disease. A second-generation antisense drug, ISIS 301012 reduces levels of apoB-100, a protein critical to the synthesis and transport of low-density lipoprotein cholesterol and very-low-density lipoprotein.

• MediciNova Inc., of San Diego, completed enrollment of 297 patients with relapsing multiple sclerosis in its Phase II trial of MN-166. The company started the double-blind, placebo-controlled study with oral MN-166 in July in Eastern Europe, and efficacy data are expected in the first quarter of 2007, after one year of treatment in the two-year trial.

• Targeted Genetics Corp., of Seattle, along with the Uganda Virus Research Institute in Entebbe, Uganda, and the International AIDS Vaccine Initiative, started a Phase II trial in Uganda to evaluate the safety and immunogenicity of tgAAC09, a preventive HIV/AIDS vaccine developed by Targeted Genetics. The vaccine, based on the HIV subtype C most prevalent in southern and eastern Africa, is designed to protect uninfected people from HIV by eliciting both an antibody and a cell-mediated immune response. Parallel studies are ongoing in South Africa, and there are plans to test the vaccine in Zambia.

• TheraQuest Biosciences LLC, of Blue Bell, Pa., said the FDA accepted its investigational new drug application for TQ-1017, an extended-release Tramadol product designed to deter abuse. Under the IND, TheraQuest will begin a pilot Phase I study to evaluate the pharmacokinetics of once-daily Tramadol ER compared to short-acting tramadol (Ultram), a pain drug dosed every four to six hours. The FDA has given Tramadol ER seven years of market exclusivity for the management of post-herpetic neuralgia and for the treatment of painful HIV-associated neuropathy.