Mid-2012 Interim Analysis
Expected
Sunesis to Host Conference Call
Today at 9:00 AM Eastern Time
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the
presentation of the adaptive study design for its Phase 3 VALOR
trial of vosaroxin in acute myeloid leukemia (AML) at the Trials in
Progress Poster Session of the 2011 American Society of Clinical
Oncology (ASCO) Annual Meeting in Chicago, Illinois. The poster
(Poster #48G), entitled "Adaptive design of VALOR, a phase 3 trial
of vosaroxin or placebo in combination with cytarabine for patients
with first relapsed or refractory acute myeloid leukemia," is
available on the Sunesis website at www.sunesis.com.
VALOR, a Phase 3, multinational, randomized, double-blind,
placebo-controlled, pivotal trial, is expected to enroll 450
evaluable patients at leading sites in the U.S., Canada, Europe,
Australia and New Zealand. Its adaptive design provides for a
single interim analysis by an independent Data and Safety
Monitoring Board (DSMB), which will meet to examine pre-specified
efficacy and safety data sets and decide whether to implement a
one-time sample size adjustment of 225 additional evaluable
patients to maintain adequate power across a broad range of
clinically meaningful and statistically significant survival
outcomes. The interim analysis by the DSMB is expected to take
place in mid-2012. Unblinding of the trial is currently expected in
2013. VALOR clinical trial sites have now been opened in all
regions (North America, Europe and Australia/New Zealand) with more
than 80 sites expected to be open within the next several
months.
David Ross, M.D., Consultant Hematologist at Flinders Medical
Centre in Bedford Park, South Australia and a VALOR principal
investigator, commented, "It is frustrating that treatment
standards for relapsed AML have not changed appreciably in over 30
years. Our center elected to participate and has recently begun
enrolling in the VALOR trial based on its robust design, and
vosaroxin's clinical safety profile and unique chemotype that
evades some of the common drug resistance pathways."
"AML remains a very challenging disease with a significant need
for new treatment options, as illustrated by disappointing outcomes
of Phase 3 studies presented at this year's ASCO meeting," stated
Harry Erba, M.D., Ph.D, Associate Professor of Internal Medicine at
the University of Michigan and Steering Committee member and
principal investigator for the VALOR trial. "What is increasingly
clear from these data is that, to show a meaningful improvement in
overall survival, a new agent needs to balance improved remission
rates that translate into long leukemia free survival, including
the opportunity to bridge to potentially curative bone marrow
transplants, with low induction mortality. Vosaroxin has the
opportunity to become a new treatment standard for
relapsed/refractory AML based on its promising Phase 2 profile in a
very difficult-to-treat patient population and the adaptive VALOR
trial, which is designed to demonstrate a definitive survival
benefit across a range of meaningful outcomes."
In a Phase 2 cytarabine/vosaroxin study in first relapsed and
primary refractory AML patients, a 29% combined complete remission
rate was achieved, including a 25% complete remission rate. These
remissions were associated with a median leukemia free survival
(LFS, defined as time of complete remission to relapse or death) of
14.5 months. Six patients remain in survival follow-up with an
additional five patients having exceeded the protocol-specified
two-year maximum follow up period.
For more information on VALOR please visit
www.valortrial.com.
Conference Call Information
The Company will host a conference call today, June 6th at 9:00
a.m. Eastern Time. Harry Erba, MD, PhD, Associate Professor,
Department of Internal Medicine at the University of Michigan and
Executive Officer of the Southwest Oncology Group will join the
Sunesis senior management team in a discussion of the VALOR
adaptive design. Sunesis' management team will also provide a
general corporate update. The call can be accessed by dialing (866)
700-6293 (U.S. and Canada) or (617) 213-8835 (international), and
entering passcode 37887935. To access the live audio webcast, or
the subsequent archived recording, visit the "Investors and Media -
Calendar of Events" section of the Sunesis website at
www.sunesis.com. The webcast will be recorded and available for
replay on the company's website for two weeks.
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 approximately 100 leading sites in the U.S., Canada,
Europe, Australia and New Zealand. The VALOR trial is currently
open for enrollment and patients will be 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 broad range of clinically meaningful and
statistically significant 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 anticancer quinolone derivative,
or 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 Acute Myeloid Leukemia
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 estimated that 12,330
cases of AML were diagnosed and approximately 9,000 deaths from AML
occured in the U.S. in 2010. 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, the occurrence and timing of the DSMB interim
analysis and vosaroxin's effects, efficacy and safety profile as a
single agent and in combination with cytarabine. Words such as
"expected," "designed," "promising," "will" 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 VALOR trial until
its planned unblinding in 2013, 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 March 31, 2011
and Sunesis' other filings with the Securities and Exchange
Commission, including Sunesis' Annual Report on Form 10-K for the
year ended December 31, 2010. 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
Sunesis Pharmaceuticals (NASDAQ:SNSS)
Historical Stock Chart
From Apr 2024 to May 2024
Sunesis Pharmaceuticals (NASDAQ:SNSS)
Historical Stock Chart
From May 2023 to May 2024