Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced two
management promotions, effective October 1, 2012. Deborah A.
Thomas, Ph.D., has been promoted to Vice President, Regulatory
Affairs and Gene C. Jamieson has been promoted to Vice President,
Chemistry, Manufacturing and Controls (CMC).
Adam Craig, M.D., Ph.D., M.B.A., Executive Vice President,
Development and Chief Medical Officer of Sunesis, commented,
"Debbie and Gene have been integral members of Sunesis' management
team, each contributing to the rigorous and successful conduct of
our Phase 3 VALOR trial of vosaroxin in acute myeloid leukemia. As
we look to full enrollment of VALOR in 2013, and anticipated
unblinding of the trial in the first half of 2014, Regulatory
Affairs and CMC will be critical components of our
commercialization efforts. I congratulate Debbie and Gene on
their well-deserved promotions, and look forward to their valued
insights and leadership during this exciting time."
Dr. Thomas joined Sunesis in November 2011 as Executive
Director, Regulatory Affairs. She has over 20 years of
biotechnology and pharmaceutical industry experience, with
broad-based expertise in toxicology, project leadership and
regulatory affairs. Dr. Thomas came to Sunesis from BiPar Sciences,
where she was Vice President, Regulatory Affairs, providing
strategic input into their clinical development plans and serving
as that company's primary point of contact to the FDA. Prior
to BiPar, Dr. Thomas served in various management positions at
Genentech, Inc. from 1990 to 2007, most recently as Senior
Director, Department of Clinical Regulatory Affairs. Dr.
Thomas was awarded a B.S. in Microbiology and Ph.D. in toxicology
from the University of Kentucky.
Mr. Jamieson joined Sunesis in December 2010 as Executive
Director, CMC. He brings over 30 years of experience to the
Company, with expertise in CMC, Quality Control, Stability and
Quality Assurance, and related expertise in regulatory affairs and
product development, including assembly/authoring of multiple
regulatory submissions. Mr. Jamieson joins Sunesis from AllyCMC, a
CMC services company, where he served as Principle
Partner. Previously, he was Executive Director of Product
Development at Jazz Pharmaceuticals and Vice President,
Pharmaceutical Sciences, at NeurogesX. Mr. Jamieson was awarded a
B.S. in Chemistry from the Northern Illinois University.
About VALOR
VALOR is a Phase 3, randomized, double-blind,
placebo-controlled, pivotal trial in patients with first relapsed
or refractory AML. The trial's target enrollment is 675 patients at
more than 100 leading sites in the U.S., Canada, Europe, Australia
and New Zealand. The VALOR trial is currently enrolling patients,
who are randomized one to one to receive either vosaroxin on days
one and four in combination with cytarabine daily for five days, or
placebo in combination with cytarabine. The trial's primary
endpoint is overall survival. For more information on the VALOR
trial, please visit www.valortrial.com.
The VALOR logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=8774
About Vosaroxin
Vosaroxin is a first-in-class anti-cancer quinolone derivative
(AQD), a class of compounds that has not been used previously for
the treatment of cancer. Vosaroxin both intercalates DNA and
inhibits topoisomerase II, resulting in replication-dependent,
site-selective DNA damage, G2 arrest and apoptosis. Both the U.S.
Food and Drug Administration (FDA) and European Commission have
granted orphan drug designation to vosaroxin for the treatment of
acute myeloid leukemia. Additionally, vosaroxin has been granted
fast track designation by the FDA for the potential treatment of
relapsed or refractory acute myeloid leukemia in combination with
cytarabine.
About AML
AML is a rapidly progressing cancer of the blood characterized
by the uncontrolled proliferation of immature blast cells in the
bone marrow. The American Cancer Society estimates there will be
approximately 13,780 new cases of AML and 10,200 deaths from AML in
the U.S. in 2012. Additionally, it is estimated that the prevalence
of AML across major global markets (U.S., France, Germany, Italy,
Spain, United Kingdom, and Japan) is over 50,000. AML is generally
a disease of older adults, and the median age of a patient
diagnosed with AML is about 67 years. AML patients with relapsed or
refractory disease and newly diagnosed AML patients over 60 years
of age with poor prognostic risk factors typically die within one
year, resulting in an acute need for new treatment options for
these patients.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the
development and commercialization of new oncology therapeutics for
the treatment of solid and hematologic cancers. Sunesis has built a
highly experienced cancer drug development organization committed
to advancing its lead product candidate, vosaroxin, in multiple
indications to improve the lives of people with cancer. For
additional information on Sunesis, please visit
http://www.sunesis.com.
The Sunesis Pharmaceuticals, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=8773
SUNESIS and the logos are trademarks of Sunesis Pharmaceuticals,
Inc.
This press release contains forward-looking statements,
including statements related to Sunesis' expectations regarding the
completion and the design, conduct, progress and results of the
VALOR trial. Words such as "anticipates," "will," "enables,"
"continued" and similar expressions are intended to identify
forward-looking statements. These forward-looking statements are
based upon Sunesis' current expectations. Forward-looking
statements involve risks and uncertainties. Sunesis' actual results
and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of these
risks and uncertainties, which include, without limitation, risks
related to Sunesis' need for substantial additional funding to
complete the development and commercialization of vosaroxin, risks
related to Sunesis' ability to raise the capital that it believes
to be accessible and is required to fully finance the development
and commercialization of vosaroxin, the risk that raising funds
through lending arrangements may restrict our operations or produce
other adverse results, the risk that Sunesis' development
activities for vosaroxin could be otherwise halted or significantly
delayed for various reasons, the risk that Sunesis' clinical
studies for vosaroxin may not demonstrate safety or efficacy or
lead to regulatory approval, the risk that data to date and trends
may not be predictive of future data or results, the risk that
Sunesis' nonclinical studies and clinical studies may not satisfy
the requirements of the FDA or other regulatory agencies, risks
related to the conduct of Sunesis' clinical trials, risks related
to the manufacturing of vosaroxin and supply of the active
pharmaceutical ingredients required for the conduct of the VALOR
trial, the risk of third party opposition to granted patents
related to vosaroxin, and the risk that Sunesis' proprietary rights
may not adequately protect vosaroxin. These and other risk factors
are discussed under "Risk Factors" and elsewhere in Sunesis'
Quarterly Report on Form 10-Q for the quarter ended June 30, 2012,
Sunesis' Annual Report on Form 10-K for the year ended December 31,
2011 and Sunesis' other filings with the Securities and Exchange
Commission. Sunesis expressly disclaims any obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change
in the company's expectations with regard thereto or any change in
events, conditions or circumstances on which any such statements
are based.
CONTACT: Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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