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Actinic keratosis is a common skin condition affecting 40 million people in the United States. It is characterized by scaly, crusty patches in sun exposed areas, of which 10-15% of cases will develop into cancer if left untreated. Early clinical trial results of KX-01 demonstrated excellent activity and a much better adverse event profile, with a dramatic decrease in the frequency of severe local skin reactions, compared with the historical data of the current standard of topical therapy for actinic keratosis. Data from a Phase II study of KX-01 has been submitted to a major dermatological meeting to be held in 2018.
“The recruitment of the first patient into our pivotal Phase III clinical trials of KX-01 ointment for actinic keratosis is an important milestone for the Company,” stated Dr.
“KX-01 ointment has the potential to change the paradigm of topical therapy for actinic keratosis,” added Dr.
The KX-01 Phase III program includes two double-blind, vehicle-controlled, randomized trials totaling 600 patients. The primary endpoint will be the percentage of patients with 100% clearance in the treatment area. Both studies are being conducted in the United States.
The initiation of the KX-01 Phase III clinical trial represents the second new drug product in Phase III clinical development at
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Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: the development stage of our primary clinical candidates and related risks involved in drug development, clinical trials, regulation, manufacturing and commercialization; our need to raise additional capital; competition; intellectual property risks; risks relating to doing business in China; and the other risk factors set forth from time to time in our SEC filings, copies of which are available for free in the Investor Relations section of our website at http://ir.athenex.com/phoenix.zhtml?c=254495&p=irol-sec or upon request from our Investor Relations Department. We assume no obligation and do not intend to update these forward-looking statements, except as required by law.