Sunesis Announces MD Anderson Sponsored Trial of Vosaroxin in AML and High-Risk MDS Poster to be Presented at AACR 2014
April 02 2014 - 6:00AM
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that
updated data from the ongoing Phase 1b/2 University of Texas MD
Anderson Cancer Center-sponsored trial of vosaroxin in combination
with decitabine in older patients with previously untreated acute
myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS)
will be presented at the American Association for Cancer Research
Annual Meeting 2014 (AACR) in San Diego, California.
The poster, titled "Phase I/II study of vosaroxin and decitabine
in older patients with acute myeloid leukemia (AML) and high risk
myelodysplastic syndrome (MDS)," will be presented at the San Diego
Convention Center, Hall A-E, Poster Section 38, during the Phase
II/III Clinical Trials Poster Session on Tuesday, April 8, 2014
from 8:00 a.m. to 12:00 p.m. Pacific Time (Poster #7).
The abstract (#CT307), which includes preliminary results, can
be found on the AACR website.
Conference Call Information
Sunesis will host a conference call on Tuesday, April 8th at
8:00 a.m. Pacific Time. Study investigator, Farhad Ravandi, M.D.,
Professor of Medicine, Department of Leukemia, University of Texas
MD Anderson Cancer Center, will join the Sunesis senior management
team in a discussion of the poster presented at AACR that same day.
The call can be accessed by dialing (866) 700-6067 (U.S. and
Canada) or (617) 213-8834 (international), and entering passcode
34122691. 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 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
AML. Additionally, vosaroxin has been granted fast track
designation by the FDA for the potential treatment of relapsed or
refractory AML 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 18,860 new cases of AML and approximately 10,460
deaths from AML in the U.S. in 2014. 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 MDS
MDS is a hematopoietic stem cell neoplasm that features
dysplasia of the myeloid lineage. Hematopoiesis in these patients
is disordered and ineffective. As the numbers and quality of
blood-forming cells decline irreversibly, blood production is
further impaired and patients often develop severe anemia requiring
frequent blood transfusions. In most cases, the disease worsens and
the patient develops neutropenia and thrombocytopenia caused by
progressive bone marrow failure. In about one third of patients
with MDS, the disease progresses into AML, usually within months to
a few years.
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.
SUNESIS and the logos are trademarks of Sunesis Pharmaceuticals,
Inc.
This press release contains forward-looking statements,
including statements related to Sunesis's overall strategy, the
design, conduct, progress, timing and results of Sunesis' clinical
trials and the commercial potential for vosaroxin. Words such as
"approximately," "believe," "potential," 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
whether outstanding warrants will be exercised in the future, 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, European Commission 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 Sunesis' clinical trials, 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' Annual Report on Form 10-K for
the year ended December 31, 2013 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 Sunesis' 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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