Eric Bjerkholt Promoted to Executive
Vice President, Corporate Development and Finance
Steven Ketchum, Senior Vice
President, Research and Development, to Transition from Executive
to Board Position
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the
appointment of Adam R. Craig, M.B.B.S., Ph.D., M.B.A. to the newly
created position of Executive Vice President, Development and Chief
Medical Officer, effective March 1, 2012. In this position, Dr.
Craig will oversee the ongoing pivotal Phase 3 VALOR trial of
vosaroxin in patients with first relapsed or refractory acute
myeloid leukemia (AML) and direct Sunesis' global development
program. Dr. Craig has over 15 years of experience in
hematology, oncology and clinical development, most recently as
Chief Medical Officer of ChemGenex, a publicly-traded biotechnology
company which was acquired by Cephalon in 2011.
"Dr. Craig's extensive experience in oncology drug development,
including direct experience in bringing a hematology drug candidate
through late-stage development and filings of a U.S. NDA and
European MAA, will be invaluable to Sunesis as we prepare for our
future milestones," stated Daniel Swisher, Chief Executive Officer
of Sunesis. "We enthusiastically welcome Adam to the team, and look
forward to his contributions as we advance the VALOR trial to
completion, execute on our regulatory strategies and prepare the
market for an anticipated launch of vosaroxin in AML."
As Chief Medical Officer of ChemGenex, Dr. Craig led the
development program and regulatory strategies for omacetaxine, an
investigational treatment for chronic myeloid leukemia, including
serving as the lead presenter and moderator for a 2011 Oncologic
Drug Advisory Committee (ODAC) presentation. Before joining
ChemGenex in 2007, he was founding Chief Medical Officer at
Innovive Pharmaceuticals, Inc., a hematology-focused company. Prior
to joining Innovive, Dr. Craig held positions of increasing
responsibility at ArQule Inc., Ilex Oncology Inc., and Antisoma
plc. Dr. Craig received his medical qualifications from London
University, a Ph.D. in molecular medicine from the University of
Leeds, and an M.B.A. from the Open Business School in the United
Kingdom. Dr. Craig is a member of the Royal College of Pediatrics
and Child Health Physicians (UK) and undertook post-graduate
training in pediatrics and pediatric oncology. He also currently
serves as a member of the Commercialization Review Council for the
Cancer Prevention Research Institute of Texas, a $3 billion fund
for groundbreaking cancer research and prevention programs and
services.
"With a promising activity and safety profile, robust Phase 2
data, a rigorous and well-designed pivotal trial underway and the
potential to transform the treatment landscape for AML, vosaroxin
represents one of the most exciting candidates in late-stage cancer
drug development today," stated Dr. Craig. "I am extremely
pleased to be joining Sunesis at this exciting point in vosaroxin's
development, and I look forward to working closely with the Sunesis
team and clinical investigators to build upon the significant
momentum in the VALOR trial and bring it to a successful
outcome."
Sunesis also announced today that Eric H. Bjerkholt has been
promoted to Executive Vice President, Corporate Development and
Finance, Chief Financial Officer, reflecting his significant
contributions in the areas of corporate strategy, financial
management and fundraising at Sunesis.
Mr. Swisher stated, "Eric has played a significant role in
Sunesis' evolution over the course of his eight year
tenure. We are pleased to announce his promotion and continue
to value his leadership, particularly as we look ahead to the
commercialization of vosaroxin and to the strategic opportunities
for leveraging Sunesis' assets in markets around the
world."
Sunesis also announced that Steven B. Ketchum, Ph.D., will
transition in February from his executive role as Senior Vice
President, Research and Development, to a member of Sunesis' Board
of Directors, in order to take an executive role at a
biopharmaceutical company based closer to his family home in New
Jersey. Dr. Ketchum will transfer his executive
responsibilities to Dr. Craig, and will continue to support
corporate strategy as a Director.
Mr. Swisher continued, "We are indebted to Steve for his many
contributions at the executive level, particularly his strong
development and regulatory leadership and close collaboration with
Dr. Judy Fox, our ongoing Program Leader, in advancing vosaroxin
from Phase 2 into a rigorous, pivotal, multi-national Phase 3
trial. I look forward to his continued insights and leadership as a
member of our Board. Through strong teamwork and investigator
support, the VALOR trial is now recruiting patients at more than
110 sites in 14 countries, and Sunesis is on track to announce the
outcome of an interim analysis in the third quarter of this
year."
About VALOR
VALOR is a Phase 3, randomized, double-blind,
placebo-controlled, pivotal trial in patients with first relapsed
or refractory AML. The trial is expected to enroll 450 evaluable
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.
Additionally, the VALOR trial employs an innovative, adaptive trial
design that allows for a one-time sample size adjustment by the
DSMB at the interim analysis to maintain adequate power across a
broader range of survival outcomes. 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.
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
12,950 new cases of AML and approximately 9,050 deaths from AML in
the U.S. in 2011. Additionally, it is estimated that prevalence of
AML is approximately 25,000 in the U.S. 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
www.sunesis.com.
The Sunesis Pharmaceuticals, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=8773
This press release contains forward-looking statements,
including statements related to the design, conduct and results of
the VALOR trial, vosaroxin's efficacy, safety profile and
commercial potential as a single agent and in combination with
cytarabine, and the results of the planned interim analysis of the
VALOR trial and related timing. Words such as "ongoing," "future,"
"advance," "completion," "anticipated," "launch," "promising,"
"robust," "potential," "momentum," "outcome," "on track," "look
ahead," and "adequate" 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 results 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
September 30, 2011, Sunesis' Annual Report on Form 10-K for the
year ended December 31, 2010 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.
SUNESIS and the logo are trademarks of Sunesis Pharmaceuticals,
Inc.
CONTACT: Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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