• Cyclacel Pharmaceuticals Inc., of Berkeley Heights, N.J., completed enrollment in the Phase II trial of sapacitabine in elderly patients with acute myeloid leukemia. The enrollment target was achieved about three months ahead of forecast. Interim results from this trial are expected to be available by the end of the year and final results during the second half of 2009.
• Diamyd Medical AB, of Stockholm, Sweden, said that results from the company's study of the Diamyd vaccine for Type I diabetes have been published in the New England Journal of Medicine. The article, currently available on the journal's website, will be in print Oct. 30. It presented the results of the concluded Phase II study, showing that the Diamyd diabetes vaccine helped children and adolescents with Type I diabetes retain the ability to produce their own insulin without causing any serious side effects.
• Evotec AG, of Hamburg, Germany, has begun Phase I studies for its small-molecule P2X7 receptor antagonist being developed for inflammatory processes. The first study is a double-blind and placebo-controlled single ascending dose study in healthy male volunteers to evaluate the compound's safety, tolerability, pharmacokinetic profile and pharmacodynamic effects after oral administration.
• Icagen Inc., of Research Triangle Park, N.C., has started a Phase II proof-of-concept trial to evaluate the safety and efficacy of senicapoc, its orally available small-molecule inhibitor of the KCa3.1 potassium ion channel, in patients with allergic asthma. The double-blind, placebo-controlled, parallel group study will assess the safety and efficacy of senicapoc, administered once a day for two weeks, on pulmonary function in patients with allergic asthma following exposure to a known antigen. The study will enroll approximately 30 patients.
• Inspire Pharmaceuticals Inc., of Durham, N.C., has initiated a Phase I trial with INS117548 ophthalmic solution for glaucoma. The dose-escalating trial is designed to evaluate the product's safety, tolerability and intraocular pressure-lowering effects in about 60 subjects with early stage glaucoma or ocular hypertension. Inspire also has a latrunculin B compound, INS115644, related to that platform in Phase I testing.
• QLT Inc., of Vancouver, British Columbia, has initiated a Phase I safety study in healthy adults with QLT091001, an orally administered synthetic retinoid replacement therapy for 11-cis-retinal, which is a key biochemical component of the visual retinoid cycle. The open-label, single-center, ascending dose trial will determine the safety and tolerance of multiple administrations of the drug in approximately 18 healthy adult volunteers. Participants will be enrolled in up to six cohorts of increasing doses.
• Scolr Pharma Inc., of Bothell, Wash., completed patient enrollment and dosing for the third of its three pivotal trials to evaluate the safety and efficacy of its formulation of 12-hour extended-release ibuprofen for the over-the-counter market. The company expects to report top-line results in November.