phase i results are successful

Peptech successfully completes Phase I trial for PN0621 – Anti-inflammatory compound PN0621 to advance to Phase II - 29 October 2007 Sydney, Australia: Biopharmaceutical company, Peptech Limited (ASX: PTD, AIM: PTDx) today announced the completion of the Phase I trial of its lead compound for rheumatoid arthritis PN0621. Data from the trial completed in 30 healthy volunteers indicates that ascending single doses of PN0621 administered intravenously and subcutaneously were well tolerated in humans. The results of the trial, which involved the first administration to humans of a domain antibody derived product, will be key to the successful development of PN0621 and will be used in the design of Phase II trials. The Phase II program will examine the safety and efficacy of PN0621 in the treatment of rheumatoid arthritis and other inflammatory diseases. These trials are expected to commence in the first half of 2008. The Company has already manufactured sufficient quantities of PN0621 to proceed to Phase II trials. Peptech CEO Dr John Chiplin said: “We are delighted that PN0621 has passed its first clinical milestone and this is a great result both for the company and for those suffering from inflammatory disease. We look forward to moving from healthy volunteers to treating patients as we progress the clinical testing of this new generation treatment.” PN0621 is based on a domain antibody and has been tailored to be smaller than a conventional antibody while retaining similar properties in terms of capacity to bind to other molecules. This is anticipated to provide advantages over existing antibody therapies in the treatment of inflammatory diseases. There is a need for new treatments for severe rheumatoid arthritis such as PN0621 because some patients develop resistance to prolonged treatment yet respond when switched to an alternate antibody therapy. The Phase I trial participants each received a single dose of PN0621 by one of two routes: injection into a vein or under the skin. Starting at a low dose, levels were increased until the predicted therapeutic dose level was exceeded. Clinical data indicates dosing at all levels was well tolerated.

“The clinical safety data, taken together with PN0621’s excellent pre-clinical safety profile and advantages in cost of manufacture, place PN0621 in an excellent position. We can now focus on demonstrating PN0621’s efficacy in treating diseases and look to capitalise on the product’s advantages due to its smaller size compared to fullsized, conventional antibodies," Dr Chiplin concluded.