Sunesis Pharmaceuticals Issued Important U.S. Patent Covering Vosaroxin Use to Treat Leukemia
August 03 2011 - 7:00AM
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that
the U.S. Patent and Trademark Office (USPTO) issued U.S. Patent No.
7,989,468 claiming methods of use for the Company's lead drug
candidate, vosaroxin, at clinically relevant dose ranges and
schedules, for the treatment of leukemia. The '468 patent, which is
based on an application filed on March 14, 2005, is subject to a
patent term adjustment under title 35, section 154 (b) of U.S.
Code, extending its coverage through 2026. Corresponding patent
applications are pending in major markets throughout the world
including Europe, Japan, Australia and Canada. Sunesis is
currently enrolling a Phase 3, multinational, randomized,
double-blind, placebo-controlled, pivotal clinical trial of
vosaroxin in combination with cytarabine in first relapsed or
refractory acute myeloid leukemia, the VALOR trial.
"The '468 patent adds another important facet to our global
intellectual property estate for vosaroxin, providing significant
coverage for uses of vosaroxin in the treatment of leukemia
including the dose and schedule under evaluation in the pivotal,
Phase 3 VALOR trial," said Dan Swisher, Chief Executive Officer of
Sunesis. "Sunesis continues to pursue an intellectual property
strategy that we believe will provide additional exclusive coverage
in the vosaroxin patent estate. To supplement our granted
patents, we have filed patent applications in territories around
the world with claims covering additional vosaroxin formulations,
combination uses, dosing, manufacturing processes and composition
of matter claims, which may provide patent terms to 2030 when
granted."
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
occurred 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," "may" 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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