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 preliminary data showing
promising early clinical responses in the first part of a two part
study of Oraxol (oral paclitaxel and encequidar, also known as
HM30181A) monotherapy in patients with unresectable cutaneous
angiosarcoma.
To date, 10 patients have been enrolled in the clinical study,
which is being conducted in four sites in the U.S. and Hong Kong.
The first 7 patients have received at least six weeks of treatment,
which is the timepoint for the first response assessment; 3
patients have not yet reached the first assessment timepoint.
Oraxol is being administered once daily for three consecutive days
every week during the treatment period.
All 7 patients showed significant and visible reduction of the
cutaneous angiosarcoma within one or two weeks of treatment. Three
patients had complete responses based on RECIST v1.1 criteria, with
two complete responses occurring by 6 weeks of treatment.
Selected images showing early visible response in one
week, from a patient with complete response (Patient A) are
available at
http://www.globenewswire.com/NewsRoom/AttachmentNg/d1f1371f-7086-451e-99da-c4c8eeecbf64
http://www.globenewswire.com/NewsRoom/AttachmentNg/38c102f2-0bf7-44e6-aae7-2515b09e8887
http://www.globenewswire.com/NewsRoom/AttachmentNg/f69c732f-6d5b-4b9a-b64b-06307f265bd4
Selected images showing a patient with complete response
after 6 weeks of treatment (Patient B) are available
at
http://www.globenewswire.com/NewsRoom/AttachmentNg/e30decf6-d6a3-4d5e-8289-e163a4bb8f9a
http://www.globenewswire.com/NewsRoom/AttachmentNg/9d565685-8c14-40e2-bb5f-a5f8162bd3ea
None of the patients enrolled have discontinued treatment due to
death, disease progression, or adverse events. No peripheral
neuropathy has been reported.
Based on the preliminary data, the study has met the criteria
required to proceed to full enrollment.
Dr. Rudolf Kwan, Chief Medical Officer of
Athenex, stated, “I am impressed by the rapid clinical
response to Oraxol monotherapy treatment in this group of
difficult-to-treat patients. The high response rate observed,
including three patients who had early complete response, is
consistent with the hypothesis that oral delivery of paclitaxel can
potentially achieve a more desirable pharmacokinetic profile and a
better clinical outcome. I believe the good tolerance of Oraxol in
this older patient population would be welcome by both clinicians
and patients. This may represent a paradigm shift in the treatment
of patients with cutaneous angiosarcoma.”
Dr. Johnson Lau, Chairman and Chief Executive Officer of
Athenex, commented, “The consistently high response rate
observed in various clinical settings, including in the treatment
of metastatic breast cancer, unresectable gastric cancer, and now
cutaneous angiosarcoma, highlight the potential of Oraxol as an
effective therapeutic for a broad range of cancers. With results
showing high response rates, lack of significant neuropathy and
oral convenience with no need for concomitant use of intravenous
steroid pre-treatment, I believe Oraxol also has the potential to
transform treatment regimens that use a high potency
chemotherapeutic agent in combination with other newly developed
anti-cancer therapeutics. We are already evaluating the combination
of Oraxol with ramucirumab and Oraxol with an anti-PD1
(pembrolizumab) in clinical studies.”
Oraxol (oral paclitaxel and encequidar, or HM30181A) was granted
Orphan Drug Designation by the U.S. Food and Drug Administration
for the treatment of angiosarcomas in April 2018.
The clinical trial, designed and led by Principal Investigator
Vinod Ravi, M.D., associate professor of Sarcoma Medical Oncology
at The University of Texas MD Anderson Cancer Center, is open at MD
Anderson in Houston, Fred Hutchinson Cancer Center in Seattle and
Prince of Wales Hospital, Shatin, in Hong Kong. For more details
about the clinical study, please visit ClinicalTrials.gov at
https://clinicaltrials.gov/ct2/show/NCT03544567.
Athenex is completing a Phase III clinical trial of Oraxol in
the treatment of metastatic breast cancer. In April 2019, the
company presented an abstract on preclinical data of oral
paclitaxel and HM30181A (encequidar) in angiosarcoma at the
American Association of Cancer Research Annual Meeting 2019 in
Atlanta, Georgia. In December 2018, Athenex announced positive
second cohort results of Oraxol-plus-ramucirumab Phase 1b clinical
trial in gastric cancer (more details can be found here). In
October 2018, Athenex presented encouraging clinical trial efficacy
and safety results of Oraxol in the treatment of metastatic breast
cancer in a Phase II clinical trial in Taiwan at ESMO 2018 (more
details can be found here).
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.
About AngiosarcomaAngiosarcomas are a type
of soft tissue sarcoma characterized by rapidly proliferating,
extensively infiltrating, anaplastic cells derived from blood and
lymphatic vessels. Angiosarcomas arise in various body sites,
including cutaneous, soft tissue, and visceral locations.
Angiosarcomas are frequently metastatic at diagnosis, with a
natural history complicated by local recurrence, distant
metastases, and poor overall survival. Angiosarcomas represent
about 2% of soft tissue sarcomas and 5.4% of cutaneous soft tissue
sarcomas.
There is no approved treatment for angiosarcoma and survival is
limited with treatments currently available. However, reports in
the literature of objective tumor response support the use of
intravenous paclitaxel in the treatment of angiosarcoma.
About Athenex, Inc.Founded in
2003, Athenex, Inc. is a global clinical stage
biopharmaceutical company dedicated to becoming a leader in the
discovery, development and commercialization 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 Statements 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,” "preliminary",
“probable,” “project,” "promising," “seek,” “should,” “will,”
"would," 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 Sze Chief Financial Officer
Email: randollsze@athenex.com
Jacqueline Li Corporate Development and Investor Relations
Email: jacquelineli@athenex.com
Athenex, Inc.
Athenex (NASDAQ:ATNX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Athenex (NASDAQ:ATNX)
Historical Stock Chart
From Apr 2023 to Apr 2024