• Genzyme Corp., of Cambridge, Mass., said that the two-year follow-up results from a Phase II trial of its investigational therapy known as eliglustat tartrate have been accepted for publication in the journal Blood. The results have been pre-published on the journal's website. Eliglustat tartrate, a capsule taken orally, could provide an alternative for adult patients with Gaucher's disease Type I. Current treatments, including Genzyme's Cerezyme (imiglucerase for injection), the standard of care for patients with Gaucher's Type I, are administered through intravenous infusions. Genzyme currently is enrolling patients in three global, multicenter, Phase III trials of eliglustat tartrate.
• Immuron Ltd., of Melbourne, Australia, reported that results of an open-label Phase I/II trial of two oral formulations of hyperimmune bovine colostrum powder (BCP), Imm122-I and Imm124-E, had a beneficial effect in patients with liver disease nonalcoholic steatohepatitis (NASH) – a chronic inflammatory disorder of the liver – insulin resistance and hyperlipidemia. In the trial, two groups of 10 patients with NASH were treated for 30 days followed by a 30-day safety monitoring period. One group was treated with two oral capsules, each equivalent to 100 mg Imm122-I hyperimmune BCP, three times per day, while the other group was treated with two oral tablets per day, each equivalent to 200 mg of hyperimmune Imm124-E BCP. The study demonstrated an improvement in liver function.
• InSite Vision Inc., of Alameda., Calif., has initiated a Phase I/II trial of ISV-303, a topical anti-inflammatory product intended to reduce the pain and inflammation associated with ocular surgery. While the trial is not designed to achieve statistical significance, results from the study are expected to provide guidance on the design of a Phase III clinical program. The company expects to report initial data from the study in early 2011 , and those results will guide the design of Phase III studies, which could begin as early as the second half of next year.