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www.fdanews.com/articles/98059-peplin-completes-enrollment-in-actinic-keratosis-trial

Peplin Completes Enrollment in Actinic Keratosis Trial

September 5, 2007

Australian drugmaker Peplin announced the completion of enrollment in its Phase II trial of PEP005 topical, a potential treatment of actinic keratosis.

Actinic keratosis is a common skin condition that can develop into cancer.

The PEP005-007 study is an 88-patient, open-label, multicenter, dose-escalation trial in Australia and New Zealand designed to evaluate the safety and tolerability of PEP005 when applied to sun-damaged skin on the face and scalp, Peplin said.

The primary study objective is to evaluate the optimal tolerated dosage of PEP005. Secondary objectives of lesion clearance will be evaluated, the company added.

The company said it intends to complete an interim evaluation of safety and tolerability data and expects to announce the results in October with final results available later in the fourth quarter.