Clinical trials for actinic keratosis and basal cell carcinoma

Peplin Limited expects to announce results of the first of its phase IIa clinical trials in the week of 28 November 2005. This clinical trial is one of four phase IIa clinical trials of Peplin’s proprietary product PEP005 Topical conducted during 2005 at sites in Australia and the US for actinic keratosis (AK) and two forms of basal cell carcinoma (BCC).

Data from this first trial is currently being collated and analysed ahead of a meeting by Peplin with the investigating dermatologists who participated in the study. This meeting will review the data and evaluate the results and Peplin expects to make an announcement to the market immediately following that review.

Also, Peplin expects to be in a position to report preliminary results of its open label US-based phase IIa clinical trial in AK before the end of December 2005. This trial is a dose escalation study applying progressively higher concentrations of PEP005 Topical onto an area of skin containing an AK to establish the maximum tolerated dose of the drug.

Peplin continues to enroll patients into its two phase IIa BCC clinical trials. Based on current recruitment rates Peplin expects to complete enrolment in coming weeks and report results in April 2006.

Each of Peplin’s three Australian-based phase IIa skin cancer clinical trials is a multi-centre, randomised, double-blind, parallel-group, vehicle-controlled study to determine the safety of PEP005 Topical containing 0.0025%, 0.01% or 0.05% of the active ingredient in two alternative treatment regimens comprising either day 1 and day 2 or day 1 and day 8 applications to approximately 60 patients.

The primary objective in each of these clinical trials is to determine the safety of PEP005 Topical when administered on two days. The secondary objectives of each study are to evaluate the efficacy of the drug, to determine a recommended treatment regimen for further evaluation in Phase IIb studies and to evaluate patients for cosmetic outcome.

Source: RefillPill.com Editors' Choice