CORRECTION: Athenex Announces Positive Second Cohort Results of Oraxol-plus-Ramucirumab Phase 1b Clinical Trial in Gastric Ca...
December 11 2018 - 12:46PM
In a press release issued under the same headline earlier today by
Athenex, Inc., please note that the dosing regimen should be
“mg/m2,” rather than “mg/kg,” as was stated in the earlier release.
The corrected press release follows:
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/m2
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/m2, 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/m2 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.
Forward-Looking Statement 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.
CONTACTS Investor Relations: Tim McCarthy
Managing Director, LifeSci Advisors, LLC Tel: +1
716-427-2952 Direct: +1 212-915-2564
Athenex, Inc.: Randoll SzeChief Financial Officer
Email: randollsze@athenex.com Jacqueline LiCorporate
Development and Investor Relations
Email: jacquelineli@athenex.com
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