• Barrier Therapeutics Inc., of Princeton, N.J., completed patient enrollment for its pivotal Phase III study of Hyphanox, an oral formulation of the antifungal agent itraconazole, in toenail onychomycosis. The trial is designed to compare the efficacy of once-daily dosing of one 200-mg tablet of Hyphanox to two 100-mg capsules of generic itraconazole for three months, with efficacy defined as both complete clinical and mycological cure of the toenail fungal infection at nine months following end of treatment. The trial involves more than 1,370 patients. Barrier anticipates reporting top-line results in the fourth quarter of 2008.

• Diffusion Pharmaceuticals LLC, of Charlottesville, Va., reported positive results from a Phase I trial of its lead drug candidate, trans sodium crocetinate (TSC) in healthy volunteers, who showed that the drug was well tolerated and raised no significant clinical issues in humans at doses significantly higher than the doses to be used in upcoming trials. In other news, Diffusion said it completed a $4.5 million private placement, with proceeds expected to fund its overall growth and to advance TSC into Phase II studies early next year in peripheral vascular disease and brain cancer.

• Oncolytics Biotech Inc., of Calgary, Alberta, said interim results from a UK Phase Ia/Ib combination Reolysin and radiation trial in patients with advanced or metastatic cancers show that, of 11 patients in the Phase Ia portion who received two intratumoral treatments of Reolysin, given at four different dosages, with a constant localized radiation dose of 20 Gy given in five fractions, three experienced significant partial responses. One month following treatment, a patient with esophageal cancer experienced a 28.5 percent reduction in the target tumor, with stable disease noted in four, nontreated tumors. A patient with squamous skin cancer experienced a 50 percent reduction in the target tumor at one, two and three months post-treatment, and a squamous-cell scalp patients showed stable disease in the target tumor for two months and then showed partial response at three months.

• Trophos SA, of Marseille, France, began enrolling patients in a Phase Ib trial of TRO19622 in spinal muscular atrophy. The study is expected to involve 20 Type Ib through Type III SMA patients between the ages of six and 25 to assess the pharmacokinetics and safety following administration of single and multiple doses given orally once per day. TRO19622 was discovered using Trophos' neuronal cell screening platform and preclinical studies demonstrated that promotes the survival of a wide range of neurons under disease-relevant stress conditions. The product has been granted orphan drug designation by European regulators.

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