Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the
publication in Leukemia of data from a Phase 1b multi-center study
of vosaroxin in relapsed or refractory leukemia. The results show
that single-agent vosaroxin was well-tolerated, with a potent
anti-leukemic effect in patients who had received multiple prior
therapies. The Phase 1b data, along with results from Phase 2
studies of vosaroxin used alone and in combination with cytarabine
in the treatment of acute myeloid leukemia (AML), support the
Company's currently-enrolling VALOR trial, a Phase 3,
multinational, randomized, double-blind, placebo-controlled,
pivotal clinical trial of vosaroxin in combination with cytarabine
in first relapsed or refractory AML.
"Due to the high rate of resistance to available chemotherapy
regimens, treatment outcomes for aggressive leukemias such as
relapsed or refractory AML remain largely unsatisfactory,
underscoring the urgent need for new treatment options," said
Jeffrey E. Lancet, MD, Associate Member and Section Chief of
Leukemia/MDS at the H. Lee Moffitt Cancer Center and Research
Institute, lead author of the study and a principal investigator in
the VALOR trial. "With its unique mechanism of action, good
tolerability and strong signals of anti-leukemic activity in both
relapsed and refractory disease, vosaroxin warrants aggressive
analysis in the treatment of advanced AML. Our center in Tampa,
Florida is actively recruiting patients to the pivotal VALOR trial,
one of the largest studies undertaken to date in the
relapsed/refractory AML population."
Steven B. Ketchum Ph.D., Senior Vice President, Research and
Development, said: "The VALOR study is built on a significant
dataset from Phase 1 and 2, including results published in the
Leukemia article. VALOR's robust, adaptive design factors in these
datasets and addresses a range of potential survival outcomes for
both the experimental and control arms, enabling the observation of
a clinically meaningful and statistically significant survival
benefit in the vosaroxin plus cytarabine (experimental) arm
relative to the placebo plus cytarabine (control) arm across a
range of scenarios. We continue to open study centers around
the world and to maintain progress towards an interim analysis of
the VALOR trial data by the Data Safety Monitoring Board in
mid-2012."
The Phase 1b clinical trial was designed to evaluate the safety
and tolerability of escalating doses of vosaroxin and to establish
the maximum-tolerated dose (MTD) in two treatment schedules. A
preliminary assessment of vosaroxin's anti-tumor activity as a
single agent was a secondary objective of the trial. Overall,
vosaroxin was generally well tolerated, with a dose-limiting
toxicity of reversible Grade 3 - 4 oral mucositis. Of 73 treated
patients with advanced relapsed or refractory leukemia, including
AML (85 percent of patients), myelodysplastic syndrome (MDS), acute
lymphoblastic leukemia (ALL), or chronic myeloid leukemia (CML) in
blast crisis, a morphologic leukemia-free state, defined by bone
marrow blasts reduced to less than 5%, was achieved in 16 patients
at a median 32.5 days after the first dose of vosaroxin. A
combined complete response was achieved in five patients, all of
whom presented with AML. The MTD was established at 72 mg/m2 weekly
and 40 mg/m2 twice weekly.
The Leukemia article and full, published dataset are available
online at
http://www.nature.com/leu/journal/vaop/ncurrent/full/leu2011157a.html.
Vosaroxin has subsequently been studied in two Phase 2 studies
of AML patients to further define doses and regimens suitable for
Phase 3 studies, including the ongoing VALOR trial.
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
"show," "support," "warrants," "enabling," "continue," "progress"
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
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