Phase I Safety Study in Atopic Dermatitis
Genesis Research Announces Results of Phase I Safety Study in Atopic Dermatitis
Genesis Research and Development Corporation (NZSE / ASX: GEN) and SR Pharma plc (LSE: SPA) today announced the successful completion of a Phase I safety study of AVAC™ for the treatment of atopic dermatitis (also known as eczema) in children, which showed that AVAC was safe and well tolerated.
This trial of AVAC for atopic dermatitis in children follows a Phase I trial in adults completed in 2002. The present study, conducted in Wellington, involved 12 children aged 5 to 16 years.
All children received three intradermal injections of AVAC, at intervals of two weeks and were monitored closely for safety. Subjects were divided into four groups and were treated sequentially, with each dose group completing its assigned course of three injections before the next higher dose group commenced.
Injection site reactions were the major side effect of treatment, but there were no serious adverse events reported.
Although this small study was not designed to measure efficacy, clinical improvement in atopic dermatitis was noted in the majority of the children as measured by a standard scoring system for eczema.
Genesis Chief Executive Dr. Jim Watson says, “We are cautiously optimistic about this result. With the Phase I safety data in hand, we can now move ahead to our planned placebo-controlled Phase II trial, scheduled to start in the second quarter of 2003.
The Phase II trial will allow us
to accurately determine any benefits resulting from AVAC