This safety trial of AVAC!

[peterb]

International  


Wednesday March 5, 6:07 PM
SR Pharma/AVAC: Follows Phase I Trials In Adults
Edited Press Release

LONDON (Dow Jones)--SR Pharma plc and Genesis Research and Development Corporation Wednesday announced the successful completion of a phase I safety study of AVAC(TM), 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, the companies said.

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 company said. The present study, also conducted in Wellington, New Zealand, involved 12 children aged five to 16 years. All children received three intradermal injections of AVAC at intervals of two 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", Kennard said.