SR Pharma plc and Genesis Research and Development Corporation announced the successful completion of a phase I safety study of AVAC, a derivative of M. vaccae, for the treatment of atopic dermatitis (also known as eczema) in children. In this study, AVAC offered a good safety profile and was well tolerated. Mild injection site reactions were the most common side effect of treatment. No serious adverse events were reported.

This safety trial of AVAC for atopic dermatitis in children follows a phase I trial in adults completed in 2002. The present study, also conducted in Wellington, New Zealand, involved 12 children aged 5 to 16 years. All children received three intradermal injections of AVAC at intervals of 2 weeks.

Chief Operating Officer of SR Pharma Dr. David Kennard said: "The completion of phase I safety studies in both children and adults warrants further evaluation of AVAC in clinical trials. A placebo-controlled phase II trial in children suffering from eczema is scheduled to start in the second quarter of 2003. The phase II trial will allow us to accurately determine any benefits resulting from AVAC treatment."