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Athenex Announces Positive Second Cohort Results of Oraxol-plus-Ramucirumab Phase 1b Clinical Trial in Gastric Cancer
BUFFALO, N.Y., Dec. 11, 2018 (GLOBE NEWSWIRE) -- Athenex, Inc., a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer, today announced that its global Phase 1b clinical trial of Oraxol (oral paclitaxel plus HM30181A) plus ramucirumab (monoclonal antibody to VEGF-R2) in gastric cancer patients who failed previous chemotherapies has completed the study of the second cohort of patients. The results indicated strong positive signals of efficacy and the treatment was well tolerated.
In the first cohort of six patients treated with a 200 mg/kg dose of Oraxol, partial responses were observed in 2/6 patients (33.3%) and stable disease observed in 1/6 patient (16.7%). There was one severe adverse event (SAE) of grade-4 neutropenia in one patient who had complete recovery from this event.
Athenex now reports that for the second cohort of six patients on an escalated Oraxol dose of 250 mg/kg, partial response, according to RECIST criteria, occurred in 3 patients (50%). There was one SAE of grade-3 vomiting in one patient, who elected to withdraw from the study and subsequently had complete recovery. The Oraxol dose is currently being further escalated to 300 mg/kg in the third cohort of patients and the study is ongoing.
"We are pleased by the strong positive signals of efficacy together with a good safety profile in this Phase 1b clinical trial of Oraxol plus ramucirumab in the second-line treatment of gastric cancer patients so far and look forward to further results from the continuation of this study. The results also echoed the strong positive signal that we have observed in other clinical studies of Oraxol as monotherapy for the treatment of metastatic breast cancer," stated Dr. Rudolf Kwan, Athenex's Chief Medical Officer.
Oraxol is a novel oral formulation of paclitaxel currently in Phase 3 clinical trial in metastatic breast cancer.
Ramucirumab, as a single agent or in combination with paclitaxel, is FDA-approved for the treatment of patients with advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. Ramucirumab is manufactured and marketed by Eli Lilly and Company under the name CYRAMZA®.
The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.
PharmaEssentia Corp. licensed the Taiwan, Singapore and Vietnam rights of Oraxol from Athenex and is a partner in the development of Oraxol in the territory.
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. The Company’s current clinical pipeline is derived from four different platform technologies: (1) Orascovery, based on non-absorbed P-glycoprotein inhibitor, (2) Src kinase inhibition, (3) T-cell receptor-engineered T-cells (TCR-T), and (4) Arginine deprivation therapy. 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. For more information, please visit www.athenex.com.
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. These forward-looking statements are typically identified by terms such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “foresee,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “will,” and similar expressions. 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 reliance on third parties for success in certain areas of Athenex’s business; our history of operating losses and need to raise additional capital to continue as a going concern; 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. All information provided in this release is as of the date hereof and we assume no obligation and do not intend to update these forward-looking statements, except as required by law.
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