• 7TM Pharma A/S, of Horsholm, Denmark, began a Phase I/II trial of TM30339, an obesity agent derived from the company's discovery program on Y4 receptor selective agonists. The company said TM30339 mimics a natural satiety signal from the gastrointestinal tract involved in the regulation of food intake.

• Adherex Technologies Inc., of Research Triangle Park, N.C., said an investigator presented data from Adherex's European Phase Ib/II study of single-agent ADH-1 in solid tumors. Data from 30 patients showed tolerability, predictable pharmacokinetics and potential antitumor activity in five patients with advanced, chemotherapy-resistant cancer. A maximum tolerated dose was not defined. Data from a North American single-agent Phase II trial and Phase I combination studies are expected to be available later this year.

• Alba Therapeutics Corp., of Baltimore, completed enrollment and dosing of patients in its Phase IIa trial of AT-1001, an orally administered zonulin receptor antagonist for treating celiac disease. The randomized, double-blind, placebo-controlled trial is designed to evaluate the safety, tolerability and efficacy of AT-1001 in 86 CD subjects during gluten challenge. Patients were randomized into seven drug-treated and placebo groups and challenged with gluten three times a day for 14 days. Celiac disease is a T-cell-mediated autoimmune disease characterized by small intestinal inflammation, injury and intolerance to gluten.

• Antisoma plc, of London, said its second, confirmatory Phase II trial of AS1404 in non-small-cell lung cancer produced positive results. The 30-patient study tested AS1404 in combination with carboplatin and paclitaxel chemotherapy. Investigators reported a response rate of 50 percent. A further 43 percent of patients showed disease stabilization, while only 7 percent had progressive disease as their best response. The addition of AS1404 to chemotherapy was well tolerated despite the use of a dose 50 percent higher than that used in previous combination studies. An earlier Phase II study in lung cancer showed a five-month increase in median survival for the same regimen.

• Depomed Inc., of Menlo Park, Calif., completed patient enrollment in its pivotal Phase III trial designed to evaluate the safety and efficacy of Gabapentin for the treatment of postherpetic neuralgia. Results are expected mid-year. The randomized, double-blind, placebo-controlled trial enrolled 407 patients. Gabapentin GR is an extended-release formulation of gabapentin, an FDA-approved product for the treatment of PHN, formulated with Depomed's AcuForm delivery technology.

• Diamyd Medical AB, of Stockholm, Sweden, disclosed plans for Phase III development of its Diamyd product for treating diabetes, following communication with the FDA. It said a Phase III trial in the U.S. and a parallel Phase III trial in Europe should be suitable for product registration to treat Type I diabetes. Each double-blind, placebo-controlled study would enroll about 300 patients within three months of diagnosis. The primary endpoint would be levels of meal-stimulated C-peptide as a direct marker of endogenous insulin production. GAD65, an auto-antigen in autoimmune diabetes, is the active substance in Diamyd.

• La Jolla Pharmaceutical Co., of La Jolla, Calif., disclosed positive interim antibody results from its ongoing double-blind, placebo-controlled, randomized Phase III trial of Riquent (abetimus sodium) for treating systemic lupus erythematosus. Interim data indicated patients treated with 900 mg or 300 mg of Riquent per week had greater reductions in antibodies to double-stranded DNA than patients treated with 100 mg per week or placebo. La Jolla's stock (NASDAQ:LJPC) gained 97 cents Thursday, or 30.7 percent, to close at $4.13.

• Myriad Genetics Inc., of Salt Lake City, initiated the first Phase II trial of its therapeutic candidate Azixa (MPC-6827) in patients with brain cancer. The trial will evaluate safety and its ability to improve the survival of patients with glioblastoma multiforme, with and against oxaliplatin treatment. Azixa is believed to have a dual mode of action: as both a cytotoxin and a vascular disrupting agent. The first stage of the study will include about 16 patients.

• The Immune Response Corp., of Carlsbad, Calif., said the first patient was injected in a Phase II study of NeuroVax, a T-cell-receptor peptide vaccine for the treatment of relapsing-remitting multiple sclerosis. The multicenter, randomized, double-blind, placebo-controlled 48-week study is designed to assess the safety and efficacy of NeuroVax in 200 patients in Central and Eastern Europe. The primary clinical endpoint is the cumulative number of new gadolinium-enhancing lesions, a marker of MS disease activity. Secondary objectives include additional MRI measurements, analysis of clinical relapses, measures of neurologic disability, immunologic evaluations and safety. NeuroVax is believed to work by enhancing levels of FOXP3+ regulatory T cells. Immune Response's stock (OTC BB:IMRP) gained 14 cents Thursday, or 11.9 percent, to close at $1.32.

• Topigen Pharmaceuticals Inc., of Montreal, began a second, expanded, 14-day Phase II trial of inhaled TPI ASM8, an RNA-targeting drug being developed to treat asthma. The 60-patient, parallel-group Phase II study in Canada will evaluate the effects of two doses of TPI ASM8 vs. placebo. The trial will assess reductions in sputum eosinophils, as well as safety and tolerability.

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