Cascadian Therapeutics Announces Approval of Nonproprietary Name “tucatinib” for Lead Product Candidate ONT-380
August 31 2016 - 4:02PM
Cascadian Therapeutics (NASDAQ:CASC), a clinical-stage
biopharmaceutical company, today announced that the United States
Adopted Names (USAN) Council and the International Nonproprietary
Names (INN) Expert Group have approved the nonproprietary name
"tucatinib" for ONT-380, the Company’s lead product candidate for
the treatment of advanced, metastatic HER2+ breast cancer.
“We’re pleased to adopt the new nonproprietary name tucatinib
for our lead product candidate, ONT-380,” said Scott Myers,
President and CEO of Cascadian Therapeutics. “Tucatinib has shown
promising systemic activity, encouraging activity against brain
metastases, and a favorable safety profile in patients with
advanced HER2+ breast cancer. We continue to enroll our Phase 2
combination trial, HER2CLIMB, and plan to report new data from our
ongoing Phase 1b ‘Triplet’ study of tucatinib in combination with
capecitabine and trastuzumab later this year.”
The USAN Council and the World Health Organization’s INN Expert
Group select simple, informative and unique nonproprietary names
for drugs based on pharmacological and/or chemical relationships to
allow for clear identification and communication among health
professionals.
About Cascadian Therapeutics Cascadian
Therapeutics is a clinical-stage biopharmaceutical company
dedicated to developing innovative product candidates for the
treatment of cancer. Our lead product candidate, tucatinib, also
known as ONT-380, is an orally active and selective small molecule
HER2 inhibitor, which has been studied in approximately 200
patients to date. Preliminary results from two ongoing Phase 1b
studies of tucatinib in combination showed promising systemic
activity, a favorable safety profile and encouraging activity
against brain metastases. Cascadian Therapeutics is also conducting
a randomized, double-blind, placebo-controlled Phase 2 study called
HER2CLIMB. The study is evaluating tucatinib versus placebo in
combination with capecitabine and trastuzumab in late stage HER2+
breast cancer patients, with and without brain metastases, who have
previously been treated with a taxane, trastuzumab, pertuzumab and
T-DM1. This study is expected to enroll 180 patients with and
without brain metastases across approximately 100 clinical sites in
the U.S., Canada, and Western Europe. The Company is also
developing a cell cycle inhibitor, Chk1, and plans to move the
program forward through IND-enabling studies in 2017. For more
information, visit www.cascadianrx.com.
Forward-Looking Statements In order to provide
Cascadian Therapeutics' investors with an understanding of its
current results and future prospects, this release contains
statements that are forward-looking. Any statements contained in
this press release that are not statements of historical fact may
be deemed to be forward-looking statements. Words such as
"believes," "anticipates," "plans," "expects," "will," "intends,"
"potential," "possible" and similar expressions are intended to
identify forward-looking statements. These forward-looking
statements include Cascadian Therapeutics' expectations regarding
clinical development activities, timing of additional data and
potential benefits of its product candidates.
Forward-looking statements involve risks and uncertainties
related to Cascadian Therapeutics' business and the general
economic environment, many of which are beyond its control. These
risks, uncertainties and other factors could cause Cascadian
Therapeutics' actual results to differ materially from those
projected in forward-looking statements, including the risks
associated with the costs and expenses of developing its product
candidates, the adequacy of financing and cash, cash equivalents
and investments, changes in general accounting policies, general
economic factors, achievement of the results it anticipates from
its preclinical development and clinical trials of its product
candidates and its ability to adequately obtain and protect its
intellectual property rights. Although Cascadian Therapeutics
believes that the forward-looking statements contained herein are
reasonable, it can give no assurance that its expectations are
correct. All forward-looking statements are expressly qualified in
their entirety by this cautionary statement. For a detailed
description of Cascadian Therapeutics' risks and uncertainties, you
are encouraged to review the documents filed with the securities
regulators in the United States on EDGAR and in Canada on SEDAR.
Except as required by law, Cascadian Therapeutics does not
undertake any obligation to publicly update its forward-looking
statements based on events or circumstances after the date
hereof.
Additional Information Additional information
relating to Cascadian Therapeutics can be found on EDGAR at
www.sec.gov and on SEDAR at www.sedar.com.
Investor Contact:
Julie Rathbun
Rathbun Communications
206-769-9219
ir@cascadianrx.com
Tricia Truehart
The Trout Group
646-378-2953
ttruehart@troutgroup.com
Media Contact:
Amy Bonanno
BMC Communications
646-513-3117
abonanno@bmccommunications.com
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