Arbutus Reports Topline Results from TKM-PLK1 HCC Clinical Trial
July 19 2016 - 4:30PM
Promising Anti-Tumor Activity ObservedArbutus to
Explore Partnership Options to Enable Further Study
Arbutus Biopharma Corporation (Nasdaq:ABUS), an industry-leading
hepatitis B virus (HBV) therapeutic solutions company, today
reported topline results from the completed Phase I/II TKM-PLK1
clinical study in patients with advanced Hepatocellular Carcinoma
(HCC). Arbutus intends to explore partnership opportunities to
enable further study of TKM-PLK-1 in HCC.
Arbutus today reported the following topline
results from the Phase I/II study of TKM-PLK1 in HCC:
- TKM-PLK1 was well-tolerated at all dose levels;
- 51% of subjects showed overall stable disease (SD) according to
RECIST criteria;
- 22% of subjects showed an overall partial response (PR)
according to Choi response criteria;
- Tumor density reduction of up to 59% was observed;
“We are encouraged by the results from the
TKM-PLK1 clinical trial in HCC patients and believe it supports
further evaluation of this candidate as a potential treatment for
HCC,” said Dr. Mark Kowalski, Arbutus’ Chief Medical Officer. “The
observed radiographic tumor density changes are consistent with
tumor necrosis in a significant proportion of subjects, warranting
further study of TKM-PLK1 for HCC, alone and in combination with
other therapies.”
“We are very pleased to report the positive
results of this study of TKM-PLK1 in HCC, which we view as further
validation of our capability to develop promising product
candidates using our proprietary LNP delivery technology,” said Dr.
Mark J. Murray, Arbutus’ President and CEO. “Given Arbutus’ focus
on HBV, we look forward to finding the right partner to advance the
development of TKM-PLK1 for HCC and maximize the value of this
asset for our shareholders.”
Trial DesignThe Phase I/II
TKM-PLK1 HCC clinical study was an open-label, multi-center, study
in patients with advanced HCC conducted in the US, Asia, and
Canada. The trial was designed to assess the safety, tolerability,
pharmacokinetics, and preliminary efficacy of the product. TKM-PLK1
was administered weekly with each four-week cycle consisting of
three once-weekly doses followed by a rest week. The study included
a total of 43 subjects (12 subjects in the dose escalation arm,
followed by 31 subjects in the expansion cohort). The HCC efficacy
endpoint of the study was tumor response rate.
About TKM-PLK1TKM-PLK1
(TKM-080301) is a lipid nanoparticle (LNP) encapsulated small
interfering RNA (siRNA) directed against polo-like kinase 1 (PLK1),
a protein involved in tumor cell proliferation and a validated
oncology target. Inhibition of PLK1 expression prevents the tumor
cell from completing cell division, resulting in cell cycle arrest
and death of the cancer cell. TKM-PLK1 has been evaluated in
clinical trials with patients who have HCC, gastrointestinal
neuroendocrine tumors (GI-NET), and adrenocortical carcinoma
(ACC).
About Arbutus Arbutus Biopharma
Corporation is a biopharmaceutical company dedicated to
discovering, developing and commercializing a cure for patients
suffering from chronic HBV infection. Arbutus is
headquartered in Vancouver, BC, Canada with offices in Doylestown,
PA, USA. For more information, visit www.arbutusbio.com.
Forward Looking Statements and
InformationThis press release contains forward-looking
statements within the meaning of the Section 27A of the Securities
Act of 1933 and Section 21E of the Securities Exchange Act of 1934,
and forward looking information within the meaning of Canadian
securities laws (collectively, “forward-looking statements”).
Forward-looking statements in this press release include statements
about exploring partnership opportunities to enable further study
of TKM-PLK-1 in HCC.
With respect to the forward-looking statements
contained in this press release, Arbutus has made numerous
assumptions regarding, among other things: the effectiveness and
timeliness of preclinical and clinical trials, and the usefulness
of the data; the continued demand for Arbutus’ assets; and the
stability of economic and market conditions. While Arbutus
considers these assumptions to be reasonable, these assumptions are
inherently subject to significant business, economic, competitive,
market and social uncertainties and contingencies.
Additionally, there are known and unknown risk
factors which could cause Arbutus' actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements contained herein. Known risk factors
include, among others: anticipated pre-clinical and clinical trials
may be more costly or take longer to complete than anticipated, and
may never be initiated or completed, or may not generate results
that warrant future development of the tested drug candidate;
Arbutus may not receive the necessary regulatory approvals for the
clinical development of Arbutus' products; economic and market
conditions may worsen; and market shifts may require a change in
strategic focus.
A more complete discussion of the risks and
uncertainties facing Arbutus appears in Arbutus' Annual Report on
Form 10-K and Arbutus' continuous disclosure filings, which are
available at www.sedar.com and at www.sec.gov. All
forward-looking statements herein are qualified in their entirety
by this cautionary statement, and Arbutus disclaims any obligation
to revise or update any such forward-looking statements or to
publicly announce the result of any revisions to any of the
forward-looking statements contained herein to reflect future
results, events or developments, except as required by law.
Contact Information
Investors
Adam Cutler
Senior Vice President, Corporate Affairs
Phone: 604.419.3200
Email: acutler@arbutusbio.com
Helia Baradarani
Senior Manager, Investor Relations
Phone: 604.419.3200
Email: hbaradarani@arbutusbio.com
Media
Please direct all media inquiries to: media@arbutusbio.com
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