Athenex Meets Enrollment Target for Oraxol Phase III Clinical Trial in Metastatic Breast Cancer
February 15 2018 - 8:00AM
Athenex (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 that the enrollment of patients is on target for the
Company to be able to conduct a second interim analysis in the
Oraxol KX-ORAX-001 Phase III clinical trial in the third quarter of
2018.
Oraxol, an innovative development in the treatment of cancer, is
a novel oral formulation of paclitaxel, a very effective and
commonly used chemotherapy treatment for many cancers, combined
with HM30181A (a novel orally non-absorbable gastrointestinal tract
P-glycoprotein pump inhibitor). The Oraxol KX-ORAX-001 Phase III
clinical trial is an international randomized controlled clinical
trial comparing Oraxol monotherapy against intravenous (IV)
paclitaxel monotherapy in patients with metastatic breast cancer,
with target sample size of 360 patients. The study is designed to
show superiority of clinical efficacy of Oraxol over IV paclitaxel
based on independently confirmed response rates.
In accordance with the protocol the Company conducted a first
interim analysis when 90 patients completed 18 weeks of treatment
in October 2017. Based on that analysis, the independent Drug
Safety Monitoring Board (DSMB) unanimously recommended continuation
of the study. The DSMB was impressed by the conduct of the study in
achieving a good overall response rate. The DSMB noticed that
neuropathy was rare with Oraxol treatment. Neuropathy is a dose
limiting toxicity of IV paclitaxel. The DSMB encouraged the rapid
patient recruitment toward the scheduled second interim analysis at
180 patients.
Athenex has already enrolled more than 180 patients and
therefore expects the second interim analysis in the third quarter
of 2018.
Dr. Rudolf Kwan, Chief Medical Officer, commented, “In January
2018, we had positive feedback from the FDA that if this study
meets the primary endpoint with an acceptable benefit/risk profile,
it could be adequate as a single comparative trial to support
registration of Oraxol for a metastatic breast cancer indication in
the United States. We are looking forward to seeing results from
the second interim analysis of this clinical trial.”
Dr. Johnson Lau, Athenex’s Chief Executive Officer and Chairman
of the Board, stated, “We are very proud of the excellent planning
and execution of our clinical team. To be able to deliver both the
enrollment for the Oraxol Phase III study on target time and the
enrollment of two Phase III studies for KX-01 Ointment for the
treatment of actinic keratosis ahead of schedule reflect the hard
work, quality and the commitment of our clinical operation team. We
are delighted that we are going to again deliver an interim
analysis of the topline Oraxol Phase III study results on schedule
as planned. Athenex is also conducting clinical studies on Oraxol
in other geographic areas as well as for the expansion of clinical
indications. We are also proud that Oraxol has recently obtained
the Promising Innovative Medicine (PIM) designation by the United
Kingdom Health Authority MHRA and also the allowance of two IND
(HM30181A and oral paclitaxel capsules) by the Chinese FDA.”
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 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
StatementExcept 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;
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.
CONTACT:Jim PolsonTel: +1-716-427-2952Athenex, Inc.
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