BUFFALO, N.Y., Nov. 20, 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 positive interim analysis results of an Oraxol pharmacokinetic (PK) study titled “Open-label, randomized cross-over bioavailability study of oral paclitaxel and HM30181 compared with weekly intravenous (IV) paclitaxel in patients with advanced solid tumors”. Patients treated with Oraxol demonstrated exposure that was comparable to IV paclitaxel and an encouraging safety profile without grade 3-4 toxicities, according to findings from this study presented at ESMO Asia 2017 in Singapore, an Annual Congress organized by the European Society for Medical Oncology.
The exposure to Oraxol compared to IV paclitaxel using PK (AUC0-∞) in the first 6 patients showed that the geometric mean ratio (GMR) was 87% (90% confidence interval (CI): 74% -101%) and the intra-subject coefficients of variation (CV) was 12%. A total sample size of 30 subjects is estimated to demonstrate equivalence between Oraxol and IV paclitaxel (90% CI of the GMR is within the limits of 80% – 125%), with 80% power. This study is expected to finish in 2018.
Christopher G.C.A. Jackson of the Department of Medicine at the University of Otago in Dunedin, New Zealand explained that paclitaxel administered orally is not absorbed due to active excretion of paclitaxel by Pgp by intestinal epithelial cells. Oraxol is a formulation of oral paclitaxel plus HM30181A, a novel oral inhibitor of intestinal p-glycoprotein (Pgp). HM30181A can enhance the bioavailability of oral paclitaxel.
Dr. Jackson highlighted that oral paclitaxel is preferable to IV administration to avoid IV site specific adverse events, systemic anaphylactic reactions and steroid pre-medications. It also reduces the time needed to administer treatment, thus offering improved convenience for both patients and clinicians and may provide health care cost-savings.
This oral presentation was selected by ESMO for inclusion in the ESMO Scientific E-News.
“These results underscore Oraxol’s potential as a future breakthrough drug and a paradigm shift for therapy of cancer and replacement of IV paclitaxel chemotherapy,” said Dr. Rudolf Kwan, Athenex’s Chief Medical Officer. “We are rapidly advancing this Oraxol clinical development program through our current Phase III clinical trial of Oraxol for the treatment of breast cancer, which is proceeding on track with rapid patient recruitment and a second interim analysis expected in 2018.”
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 Athene believes may offer improved patient tolerability and efficacy as compared to IV administration of the same cytotoxics. The Orascovery platform was developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi. 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.