Cascadian Therapeutics Appoints Dr. Marc L. Lesnick as Senior Vice President, Regulatory Affairs and Quality
January 04 2017 - 8:00AM
Cascadian Therapeutics, Inc. (NASDAQ:CASC), a clinical-stage
biopharmaceutical company, today announced the appointment of Marc
L. Lesnick, Ph.D., as Senior Vice President, Regulatory Affairs and
Quality where he will lead the development of global regulatory
strategy and quality processes, including advancing the Company’s
lead development program, tucatinib, through planned global
regulatory processes to potential registration. Dr. Lesnick
will be a member of the Company’s executive committee and will
report to Scott Myers, President and Chief Executive Officer of
Cascadian Therapeutics.
“Marc brings a wealth of product development and regulatory
affairs knowledge and expertise, with multiple successful marketing
applications in the United States and Europe,” said Scott D. Myers,
President and CEO of Cascadian Therapeutics. “His skills and deep
experience, particularly outside the United States, will help
Cascadian advance tucatinib for the treatment of patients with
HER2-positive metastatic breast cancer through late-stage
development and U.S. and international regulatory submissions.”
Dr. Lesnick was most recently Senior Vice President, U.S.
Regulatory Affairs, Global Development Projects at Shionogi, Inc.,
the U.S. subsidiary of Shionogi & Co., Ltd., where he led
regulatory strategy for an early stage dual-tyrosine kinase
inhibitor program for HER2-positive breast cancer, led the filing
of a New Drug Application (NDA) for Symproic® (naldemedine) and
oversaw approval and launch of Osphena® (ospemifene) in the field
of women’s health. In this role, Dr. Lesnick had oversight of
regulatory strategy, regulatory operations, drug safety and medical
writing. In his prior role at Optimer Pharmaceuticals, he led the
approval of Dificlir® (fidaxomicin) in the EU and Dificid®
(fidaxomicin) in the US. Dr. Lesnick held similar positions at
Verus Pharmaceuticals and PAREXEL International. Dr. Lesnick
received his Ph.D. from the University of Oregon, and continued his
post-doctoral studies at the University of California, San Diego,
School of Medicine.
About Cascadian Therapeutics
Cascadian Therapeutics is a clinical-stage biopharmaceutical
company dedicated to developing innovative product candidates for
the treatment of cancer. The lead investigational product
candidate, tucatinib, also known as ONT-380, is an oral, selective
small molecule HER2 inhibitor. Cascadian Therapeutics is conducting
a pivotal trial named HER2CLIMB to evaluate tucatinib versus
placebo in combination with capecitabine and trastuzumab in
patients with late stage HER2+ breast cancer, with and without
brain metastases. Additional details can be found at
www.clinicaltrials.gov (Identifier: NCT02614794) or
www.HER2CLIMB.com. For more information and to sign up for email
alerts or RSS feeds, please 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 tucatinib clinical development activities
and its potential benefits.
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.
All trademarks and trade names are the property of their
respective owners.
Contact:
Monique Greer
Cascadian Therapeutics
206-801-2107
mgreer@cascadianrx.com
Cascadian Therapeutics, Inc. (NASDAQ:CASC)
Historical Stock Chart
From Aug 2024 to Sep 2024
Cascadian Therapeutics, Inc. (NASDAQ:CASC)
Historical Stock Chart
From Sep 2023 to Sep 2024