Peplin Announces Positive Results of Phase IIa AK Trial
EMERYVILLE, California and BRISBANE, Australia 12 December 2007: Peplin, Inc. (ASX:PLI) today announced positive preliminary results of PEP005-007, its Australian and New Zealand based phase IIa actinic (solar) keratosis (AK) clinical trial. This trial is the first in which PEP005 Topical for AK, Peplin’s patient-applied topical gel, has been tested as a field-directed investigational therapy on the face or face and scalp treatment areas. AKs are common pre-cancerous skin lesions, caused by sun exposure, a portion of which develop into skin cancer.
PEP005-007 is an open-label, multi-center clinical trial designed to determine the optimal tolerated treatment regime and evaluate the safety and efficacy of PEP005 Topical for AK when applied to a 25 square centimeter area of skin on either the face or the face and scalp for the treatment of AK.
The clinical trial evaluated formulation strengths from 0.0025% to 0.025% (respectively, 1/10th of and equal to the lowest formulation strength studied in PEP005-006, Peplin’s clinical trial that evaluated the treatment of AK on non-facial sites) at two and three consecutive day dosing regimes.
The trial established the maximum tolerated dose (MTD) at 0.025% PEP005 Topical for AK applied daily for two consecutive days as a field directed therapy to the face or face and scalp sites.
The drug suggested a favorable safety profile and for all doses studied at and below the MTD was well tolerated. Side effects were consistent with Peplin’s earlier clinical trials and comprised primarily transient local skin responses at the treatment site. There were no drug related serious adverse events reported.
In addition, a two or three day course of PEP005 Topical for AK demonstrated complete and partial clearance of AK lesions in some patients tested at each formulation strength, with the exception of the lowest formulation strength which demonstrated partial clearance in some patients and no patients with complete clearance.
Based upon an evaluation of the local toleration profiles and complete and partial clearance rates demonstrated in this clinical trial, Peplin believes it has identified a range of doses, likely to be between 0.005% and 0.025% PEP005 Topical for AK applied daily for two consecutive days, for further development in treatment of AK on the face or face and scalp.
Finally, patient assessments in one of the
treatment groups (those patients who were scheduled to receive
three days of dosing) of convenience and ease of use, healing time,
cosmetic outcome, satisfaction compared to prior AK treatment and
overall patient satisfaction with PEP005 Topical for AK were, on
average, positive to very positive.
Peplin CEO Michael Aldridge said this trial delivered valuable information about the activity of Peplin’s drug on AK sites on the face and face and scalp.
“In particular we are pleased to have identified a range of doses which when applied to the face and face and scalp for two days are well tolerated and, which we believe may have the potential to provide clinically relevant complete AK clearance rates. We believe this information will be useful as we prepare to meet FDA to discuss plans for our clinical program through to NDA.”
Sydney dermatologist Dr Robert Rosen, who served as the trial’s lead investigator said the study supported the further development of the drug for treating AK on the face.
“AK is a skin condition associated with sun exposure and sun damage. Accordingly, the face is an important treatment site in the goal of reducing the potential for the development of skin cancer. These results, in conjunction with Peplin’s earlier clinical trial on non-facial sites, point to a product which may, with further development, provide an attractive, patient friendly and convenient treatment alternative for treating AKs on both the body or face.”
Peplin intends to discuss the results of this trial with the FDA, together with results of its previously completed PEP005-006 non-facial AK clinical trial, pre-clinical, manufacturing and other data. Peplin also intends to present plans for a clinical program and other studies required to support a new drug application (NDA) for PEP005 Topical for AK.
Peplin anticipates initiating the first clinical
study in this program in the first quarter of 2008.
Please see the attachment for the complete trial
Chief Executive Officer
Tel: +1-510 653 9700
Posted: December 2007