• Pipex Pharmaceuticals Inc., of Ann Arbor, Mich., presented the results of an open-label phase I/II clinical trial of Coprexa (oral tetrathiomolybdate) for the treatment of refractory idiopathic pulmonary fibrosis at the American Thoracic Society Annual Meeting in San Francisco. Overall, the preliminary data were positive enough to lead to a 12-month, multicenter, randomized, double-blind, placebo-controlled trial. Details of the study are expected to be published in a journal at a later date.

• Theravance Inc., of South San Francisco, Calif., presented Phase I data showing that its investigational gastrointestinal motility compound, TD-5108, has a pharmacokinetic profile consistent with once-daily dosing and prokinetic activity in healthy subjects as measured by the time to first bowel movement, frequency of bowel movements and stool consistency. Studies demonstrating the in vivo preclinical profile of TD-5108 showed that the compound has potent 5-HT4 receptor agonist activity by several routes of administration, including oral, providing robust prokinetic activity in the digestive tract of three different animal species, consistent with its 5-HT4 receptor agonist in vitro profile. The data were presented at the 2007 Digestive Disease Week in Washington. TD-5108 is in a Phase II clinical study for chronic constipation.

• Viventia Biotech Inc., of Toronto, reported final data from its recently completed dose escalation Phase I/II clinical trial of Vicinium in patients with high-risk, non-invasive bladder cancer. The trial enrolled 64 patients who were refractory or intolerant to standard treatment (BCG therapy). Patients were dosed weekly for six weeks at escalating dose levels using intravesical instillation. Although designed as a Phase I study, an efficacy analysis demonstrated that only 7 percent of those high-risk patients progressed during the study period. Vicinium was well tolerated at all dose levels with no maximum tolerated dose reached, and no patient had a dose reduction or withdrawal due to toxicity. Sustainability is being assessed in an ongoing open-label Phase II trial, which is enrolling patients with locally persistent non-invasive Cis bladder cancer in Canada and the U.S. The results were presented at the 102nd Annual Meeting of the American Urological Association in Anaheim, Calif.

• Vanda Pharmaceuticals Inc., of Rockville, Md., presented additional analyses at the American Psychiatric Association annual meeting from the Phase III trial of schizophrenia drug iloperidone. The trial previously met its primary endpoint of improvement on the positive and negative symptom scale vs. placebo, and the new data indicated fewer iloperidone-treated patients had a worsening of akathisia, a type of restlessness that is a frequent side effect of antipsychotic medications, compared to placebo, while the risperidone-treated group was equal to placebo in that measure. (See BioWorld Today, Dec. 8, 2006.)

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