Cascadian Therapeutics Receives ONT-380 Fast Track Designation from FDA for the Treatment of Advanced HER2+ Metastatic Breast...
June 29 2016 - 8:00AM
Cascadian Therapeutics (NASDAQ:CASC), a clinical-stage
biopharmaceutical company, today announced that the ONT-380 program
in advanced HER2+ metastatic breast cancer has received Fast Track
designation from the U.S. Food and Drug Administration ("FDA").
The Company is actively recruiting patients for a
randomized, double-blind, placebo-controlled Phase 2 study, known
as HER2CLIMB, evaluating ONT-380 in combination with trastuzumab
and capecitabine for patients with advanced HER2+ metastatic breast
cancer. This trial is expected to enroll up to 180 patients with
and without brain metastases. ONT-380 is an oral, highly selective
small molecule inhibitor of HER2.
“Fast Track designation recognizes the unmet medical need for
this serious disease,” said Scott Myers, President and CEO of
Cascadian Therapeutics. “Many patients with metastatic HER2+ breast
cancer will see their disease progress despite the availability and
use of multiple targeted therapies. We are encouraged by the early
evidence of systemic activity and activity against brain
metastases, and the favorable tolerability profile with ONT-380 in
combination studies.”
The FDA established the Fast Track designation process to
facilitate development and expedite the review of drugs to treat
serious conditions and fill an unmet medical need. Through the Fast
Track program, more frequent meetings may be scheduled with the FDA
to discuss the drug’s development plan and to ensure the collection
of appropriate data needed to support approval. Additionally, the
drug may qualify for accelerated approval and priority review and,
at the time of a new drug application (NDA) filing, the drug
candidate’s sponsor may be eligible to submit completed sections of
the NDA on a rolling basis before the complete application is
submitted.
“Fast Track designation has the potential to reduce development
time and cost associated with bringing a drug to patients,” said
Valerie Fauvelle, Director of Regulatory Affairs for Cascadian
Therapeutics. “We look forward to working closely with the FDA to
rapidly advance ONT-380 through the clinical development and
regulatory process.”
About Cascadian TherapeuticsCascadian
Therapeutics is a clinical-stage biopharmaceutical company
dedicated to developing innovative product candidates for the
treatment of cancer. Our lead product candidate, 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 ONT-380 in combination
showed promising systemic activity, a favorable safety profile and
encouraging activity against brain metastases. Cascadian is also
conducting a randomized, double-blind, placebo-controlled Phase 2
study called HER2CLIMB (ONT-380 + trastuzumab + capecitabine) in
patients with locally advanced or metastatic HER2+ breast cancer
previously 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. For more information, visit
www.ClinicalTrials.gov: NCT02614794. The Company is also
developing a cell cycle inhibitor, Chk1, and plans to move the
program forward through IND-enabling studies in 2017.
Forward-Looking StatementsIn 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 InformationAdditional 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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