Athenex Announces That Two Phase 3 Pivotal Efficacy Studies of KX2-391 in Actinic Keratosis Achieved Their Primary Endpoints
Athenex, Inc. (ATNX)
Last athenex, inc. earnings: 2/27 07:00 am
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Source: GlobeNewswire
BUFFALO, N.Y., July 26, 2018 (GLOBE NEWSWIRE) -- Athenex, Inc. (NASDAQ:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that both Phase 3 studies, KX-AK-003 and KX-AK-004, had achieved their primary endpoint of 100% clearance of actinic keratosis (AK) lesions at Day 57 within the face or scalp treatment areas, with each study achieving statistical significance (p These two double-blind, randomized, vehicle-controlled, studies were designed as pivotal Phase 3 efficacy and safety studies to support the registration of KX2-391 (or KX-01) as field therapy for AK of the face and scalp2,3. The studies, each conducted at 31 centers in the USA, enrolled a total of 702 subjects. KX2-391, or vehicle ointment, was applied once daily for 5 days. In addition to the clinical activity of KX2-391, the local skin reaction (LSR) profile was within expectati
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