Athenex Announces First Patient Recruitment In Phase III Clinical Trials For KX-01 Ointment For Actinic Keratosis
Published: Sep 25, 2017
BUFFALO, N.Y., Sept. 25, 2017 (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 the recruitment of the first patient into one of two Phase III clinical trials of KX-01 ointment for the treatment of actinic keratosis. KX-01, also known as KX2-391, is a novel molecule in Athenex’s portfolio. KX-01 has multiple mechanisms of action, including inhibition of Src kinase and tubulin polymerization. In preclinical studies, the compound has exhibited a broad range of anti-proliferative activity against a variety of cancer cell types as well as keratinocytes.
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. David Cutler, Athenex’s Vice President of Clinical Development.
“KX-01 ointment has the potential to change the paradigm of topical therapy for actinic keratosis,” added Dr. Rudolf Kwan, Athenex’s Chief Medical Officer.
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. Athenex and the FDA previously had an end of Phase II meeting regarding the program. Athenex expects to complete the recruitment of the Phase III studies within 8 months.
The initiation of the KX-01 Phase III clinical trial represents the second new drug product in Phase III clinical development at Athenex, providing a clear demonstration of the capabilities of the research platforms and focus of Athenex’s pipeline.
About Athenex, Inc.
Founded in 2003, Athenex, Inc. is a global clinical stage biopharmaceutical company dedicated to becoming a leader in the discovery and development of next generation drugs for the treatment of cancer. Athenex is organized around three platforms, including an Oncology Innovation Platform, a Commercial Platform and a Global Supply Chain Platform. Athenex’s Oncology Innovation Platform generates clinical candidates through an extensive understanding of kinases, including novel binding sites and human absorption biology, as well as through the application of Athenex’s proprietary research and selection processes in the lab. The Company’s current clinical pipeline is derived from two different platform technologies Athenex calls Orascovery and Src Kinase Inhibition. The Orascovery platform is based on the novel oral P-glycoprotein pump inhibitor molecule HM30181A, through which Athenex is able to facilitate oral absorption of traditional cytotoxics, which Athenex believes may offer improved patient tolerability and efficacy as compared to IV administration of the same cytotoxics. The Src Kinase Inhibition platform refers to novel small molecule compounds that have multiple mechanisms of action, including the inhibition of the activity of Src Kinase and the inhibition of tubulin polymerization during cell division. Athenex believes the combination of these mechanisms of action provides a broader range of anti-cancer activity as compared to either mechanism of action alone. Athenex’s employees worldwide are dedicated to improving the lives of cancer patients by creating more active and tolerable treatments. Athenex has offices in Buffalo and Clarence, New York; Cranford, New Jersey; Houston, Texas; Chicago, Illinois; Hong Kong; Taipei Taiwan and multiple locations in Chongqing, China.
Forward-Looking Statement Disclaimer/Safe Harbor Statement
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.