Immuron Initiates Phase II Clinical Trial For Immunotherapy Product

The clinical trial is taking place at the Hadassah Hebrew University Medical Centre in Jerusalem under an agreement between Immuron and Hadasit, the Medical Centre’s commercialisation arm.

Immuron said that the single arm, open label trial is recruiting patients who suffer from Metabolic Syndrome, particularly those with NASH and type 2 diabetes. The primary endpoints of the trial will determine the safety and efficacy of Immuron’s product for improving liver enzyme levels in patients with NASH.

The secondary endpoints will determine the efficacy of the treatment in improving Metabolic Syndrome with particular reference to insulin resistance. The endpoints will be measured using liver enzyme, glucose metabolism and T regulatory cell population measurements.

The clinical trial program follows successful animal model work, including data which was presented at the American Liver Association Meeting in 2009. The trials are designed to guide the commercialization of Immuron’s oral antibody based therapies in this area. The first group of the trial (10 patients) is expected to be fully recruited in early April with results due by the end of June 2010.

Grant Rawlin, chief executive officer of Immuron, said: “This trial will be a pivotal milestone for the Company. NASH is the most common liver disease in the western world and the incidence of Type II Diabetes is on the rise. Both of these indications represent attractive opportunities for our product.”