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news.Designed to replicate the positive results demonstrated in earlier trials
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Peplin has completed the enrolment of its two phase-III clinical trials, for the use of PEP005 (ingenol mebutate) Gel to treat actinic (solar) keratoses (AK).
These phase-III clinical trials are referred to as REGION-IIa and REGION-IIb, and enrolled approximately 250 patients each. These trials are designed to replicate the positive results demonstrated in earlier trials, specifically the results of the phase 2b trial (PEP005-015) announced earlier this year.
In addition to the REGION-II trials on head locations, Peplin recently completed its REGION-Ia trial for non-head locations, which included the trunk and extremities. It plans to initiate the REGION-Ib trial during the third quarter of 2009, to corroborate the results of the previously completed trial. Peplin plans to file a New Drug Application in mid-2010.
The REGION-II trials are both randomised, double-blind, vehicle-controlled studies, that are being conducted at multiple sites in the US and Australia.
Tom Wiggans, CEO of Peplin, said: “The REGION-II trials are especially important as they are treating AKs on the face and scalp, which comprise an estimated 70% of the AK market and have the potential to provide the most patient benefit.”
“Based on the data we have generated up to this point, we believe PEP005 Gel and its short course of therapy represent an advance in the treatment of a common skin condition, which, if left untreated, can progress to squamous cell carcinoma,” he added.