• BioCryst Pharmaceuticals Inc., of Research Triangle Park, N.C., started a Phase IIb study of BCX4208 as add-on therapy in gout patients who have not responded to allopurinol therapy alone. The 250-patient study will test the next-generation purine nucleoside phosphorylase inhibitor in combination with allopurinol in subjects who have failed to reach the serum uric acid objective of < 6 mg/dL following treatment with allopurinol 300 mg alone. The primary endpoint is the proportion of subjects with sUA < 6 mg/dL at day 85. Top-line data are expected toward the end of 2011.

• Intercell AG, of Vienna, Austria, started a Phase I trial of vaccine candidate IC84 to prevent disease caused by Clostridium difficile. The trial will enroll 60 healthy adults and up to 100 elderly subjects to test three different alum-adjuvanted vaccine concentrations. Two of the three vaccine concentrations also will be tested without adjuvant. Intercell's product is a recombinant protein vaccine consisting of two truncated toxins A and B from C. difficile.

• Medicago Inc., of Quebec City, completed the first part of its Phase II trial testing its H5N1 avian influenza vaccine. Interim results are expected in January. The study is designed to enroll about 255 healthy volunteers to test the safety and immunogenicity of different doses of the vaccine. The first part of the study called for 135 subjects to be administered twice with either a placebo or the H5N1 vaccine at varying doses to determine optimal dose. The second part will test the optimal dose against placebo.

• Three-month data from a Phase I/II trial in nine patients of ProSavin for Parkinson's disease, by Oxford BioMedica plc, of Oxford, UK, showed ProSavin was safe and well tolerated at a 2x dose using an enhanced administration technique. Motor function improvement was consistent with older dose administration methods and other endpoints were comparable or improved. The company will next use 5x dosing with the same technique in a six-patient cohort in the first quarter of 2011.

• RegeneRx Biopharmaceuticals Inc., of Rockville, Md., enrolled the first patient in a Phase II study of RGN-259, a topical eye-drop formulation of Thymosin beta 4, in patients with dry eye associated with graft-vs.-host disease. The study is expected to involve a total of 20 patients, with data reported later in 2011.

• ReNeuron Group plc, of Guildford, UK, said the Phase I study testing its ReN001 stem cell therapy for stroke will progress following a positive independent safety review of the first patient treated. The company will proceed with the remainder of the first three-patient cohort. The study, dubbed PISCES (Pilot Investigation of Stem Cells in Stroke), launched last month and is designed primarily to test the safety profile of ReN001 at a range of cell doses, though a number of efficacy measures also will be evaluated. (See BioWorld Today, Nov. 17, 2010.)

• Tekmira Pharmaceuticals Corp., of Vancouver, British Columbia, started patient dosing in a Phase I trial of TKM-PLK1 , a polo-kinase 1 inhibitor, in advanced solid tumors. The study will enroll up to 52 patients and will test safety, tolerability and pharmacokinetics as the primary objective. Secondary objectives include measuring tumor response, as well as the pharmacodynamic effects of TKM-PLK1 in patients providing biopsies. Interim data are expected in the second half of 2011.

• Theravance Inc., of South San Francisco, and partner GlaxoSmithKline plc, of London, said the first patient started treatment in a Phase IIb study of inhaled bifunctional compound GSK961080 in patients with moderate to severe chronic obstructive pulmonary disease. The 425-patient trial is designed to test once- and twice-daily administrations of GSK960180 over a 28-day period to allow for the selection of a dose and dosing interval to take forward into Phase III. The drug is designed to work both as a muscarinic antagonist and a beta2 receptor agonist.

• Threshold Pharmaceuticals Inc., of Redwood City, Calif., reported Phase I results of TH-302, a hypoxia-activated prodrug, in patients with advanced leukemias, with preliminary efficacy assessments showing activity in multiple subjects with relapsed/refractory acute myelogenous leukemia and acute lymphoblastic leukemia as evidenced by stabilization or reduction of bone marrow blast counts. The drug also has been well tolerated in the three initial dosing cohorts. Threshold also said it entered a preclinical collaboration with the M.D. Anderson Cancer Center to focus on characterizing the therapeutic efficacy of TH-302 as a monotherapy and in combination with conventional chemotherapeutics in both in vitro and in vivo models of leukemia.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., halted one arm of a Phase II trial of telaprevir in combination with its investigational HCV polymerase inhibitor, VX-222 due to viral breakthrough. VX-222 400 mg and telaprevir 1,125 mg were dosed twice daily without pegylated interferon and ribavirin. Another treatment arm was discontinued in October. The study will continue as planned with the other three treatment arms evaluating combinations of telaprevir, VX-222, pegylated interferon, and ribavirin.