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Article: Peplin Finalizes Enrollment in Its Final Phase 3 Clinical Trial for PEP005 Gel in AK
- Article from:
- Wireless News
- Article date:
- August 24, 2009
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Wireless News
08-24-2009
Peplin Finalizes Enrollment in Its Final Phase 3 Clinical Trial for PEP005 Gel in AK
Type: News
Peplin, Inc. has announced completion of enrollment in its second Phase 3 clinical trial for the use of PEP005 (ingenol mebutate) Gel to treat actinic (solar) keratoses (AK), a common pre-cancerous skin lesion, on non-head treatment areas, which include the trunk and extremities.
This completes enrollment in the final of four pivotal trials planned for the submission of the New Drug Application (NDA) for AK.
In a release, the Company noted:
This second pivotal Phase 3 trial for non-head locations, known as REGION-Ib, enrolled approximately 200 patients. It is designed ...
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Article: Clinic Roundup.
BIOWORLD Today;
July 24, 2009 ;
700+ words
... ... lesion. The trial, known as REGION-Ib, is designed to confirm ... from the recently completed REGION-I trial, which showed a ... across all anatomical non-head locations of 27.4 percent, a median ... completed two trials of PEP005 for head locations of AKs, anticipates filing ...
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