Sunesis Pharmaceuticals Announces Presentations of VALOR Data at the 20th Congress of the European Hematology Association
May 21 2015 - 8:09AM
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that
two poster presentations describing results from the VALOR trial
will be presented at the 20th Congress of the European Hematology
Association (EHA) being held June 11 – 14, 2015, at the Reed Messe
Wien Exhibition & Congress Center in Vienna, Austria. VALOR is
a randomized, double-blind, placebo-controlled Phase 3 trial which
enrolled 711 adult patients with first relapsed or refractory AML
at 124 leading sites in 15 countries. Patients were stratified for
age, geographic region and disease status and randomized one to one
to receive either vosaroxin and cytarabine or placebo and
cytarabine.
The details for the poster presentations are as follows:
Date & Time: Friday,
June 12, 2015, from 5:15 p.m. to 6:45 p.m. European Central
Time |
Poster Title: Improved
survival in patients ≥60 with first relapsed/refractory acute
myeloid leukemia treated with vosaroxin plus cytarabine vs placebo
plus cytarabine: results from the Phase 3 VALOR study |
Abstract Number: 4192 |
Session Title: Acute myeloid
leukemia – Clinical 2 |
Location: Poster area (Hall
C) |
The full abstract can be viewed here here.
Date & Time: Friday,
June 12, 2015, from 5:15 p.m. to 6:45 p.m. European Central
Time |
Poster Title: Allogeneic
transplant in patients ≥60 years of age with first relapsed or
refractory acute myeloid leukemia after treatment with vosaroxin or
placebo plus cytarabine: results from VALOR |
Abstract Number: 4693 |
Session ID: Acute myeloid
leukemia – Clinical 1 |
Location: Poster area (Hall
C) |
The full abstract can be viewed here here.
The company will also publish data from VALOR that will be on
display as an E-poster:
Date & Time: From
Friday, June 12, 2015 at 9:30 a.m. to Saturday, June 13, 2015 at
6:45 p.m. European Central Time |
Poster Title: Impact of
cytogenetics on clinical outcome in patients with first relapsed or
refractory acute myeloid leukemia treated with vosaroxin plus
cytarabine: results from VALOR |
Abstract Number: 4730 |
Location: E-Poster
Screens |
The full abstract can be viewed here here.
Conference Call Information
Sunesis will host a conference call to discuss the data on
Friday, June 12th at 10:00 a.m. Eastern Time. The call can be
accessed by dialing (866) 515-2908 (U.S. and Canada) or (617)
399-5122 (international), and entering passcode 93595855. 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 QINPREZO™ (vosaroxin)
QINPREZO™ (vosaroxin) is an anti-cancer quinolone derivative
(AQD), a class of compounds that has not been used previously for
the treatment of cancer. Preclinical data demonstrate that
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. Vosaroxin is an investigational drug that has not been
approved for use in any jurisdiction.
The trademark name QINPREZO is conditionally accepted by the FDA
and the EMA as the proprietary name for the vosaroxin drug product
candidate.
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 that there will
be approximately 20,830 new cases of AML and approximately 10,460
deaths from AML in the U.S. in 2015. 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
75,000. 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 potential 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 estimated new cases of AML, its
prevalence across major global markets, prognosis for patients with
AML, and the need for new treatment options. Sunesis' clinical
development of vosaroxin, including the analysis of the results
from VALOR clinical trial. Words such as "estimate," "potential,"
"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 result of these
risks and uncertainties, which include, without limitation, 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, risks related to the conduct of Sunesis' clinical
trials, the risk that Sunesis' clinical studies for vosaroxin may
not lead to regulatory approval, risks related to Sunesis' need for
substantial additional funding to complete the development and
commercialization of vosaroxin, and 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. 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, 2015. 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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