Sunesis Issued European Patent Covering Voreloxin Combination
July 15 2010 - 8:00AM
Marketwired
Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today announced that
the European Patent Office (EPO) has granted a European patent
covering combinations of the Company's lead drug candidate,
voreloxin, with cytarabine. Cytarabine is the standard-of-care
treatment for Acute Myeloid Leukemia (AML), and the therapy used in
combination with voreloxin in a fully enrolled Phase 2 trial in
patients with relapsed and/or refractory AML. Sunesis has also
announced plans to initiate a multinational, randomized,
double-blind, placebo-controlled, pivotal Phase 3 clinical trial of
voreloxin in combination with cytarabine in a relapsed/refractory
AML patient population in the second half of this year. European
Patent No. 1 729 770 B1, titled "SNS-595 [voreloxin] and Methods of
Using the Same," following completion of the patent validation
process, will provide patent coverage for such combination products
in 30 member states of the European Patent Convention, including
the major European markets, through 2025. Corresponding patent
applications are pending in major markets throughout the world
including Australia, Canada, Japan and the United States.
"This patent is an important new addition to our intellectual
property estate, as it covers the combination of voreloxin and
cytarabine, the contemplated initial market application," stated
Daniel Swisher, Chief Executive Officer of Sunesis. "We are
pursuing a sophisticated and deliberate strategy to provide
exclusive coverage in the voreloxin patent estate out to 2030.
Beyond our granted patents, we have filed patent applications
covering formulations, combination uses, dosing, manufacturing
processes and composition of matter claims. We look forward to the
successful prosecution of these patent applications in multiple
territories around the world."
About Voreloxin
Voreloxin 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. Voreloxin both intercalates DNA and
inhibits topoisomerase II, resulting in replication-dependent,
site-selective DNA damage, G2 arrest and apoptosis. Voreloxin is
currently being evaluated in a fully enrolled single agent Phase 2
clinical trial (known as the REVEAL-1 trial) in previously
untreated elderly AML patients and in a fully enrolled Phase 2
clinical trial combining voreloxin with cytarabine for the
treatment of patients with relapsed/refractory AML. A Phase 2
single agent clinical trial in platinum-resistant ovarian cancer
has also completed enrollment. Sunesis plans to initiate a
multinational, randomized, double-blind, placebo-controlled,
pivotal Phase 3 clinical trial of voreloxin in combination with
cytarabine in a relapsed/refractory AML patient population in the
second half of this year.
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 National Cancer Institute estimated that nearly
13,000 new cases of AML were diagnosed and approximately 9,000
deaths from AML occurred in the U.S. in 2009. 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, voreloxin, in multiple
indications to improve the lives of people with cancer. For
additional information on Sunesis Pharmaceuticals, please visit
http://www.sunesis.com.
This press release contains forward-looking statements,
including without limitation statements related to the prosecution
of patent applications and Sunesis' plans to initiate a pivotal
Phase 3 clinical trial of voreloxin in the second half of this
year. Words such as "evaluate," "planned," "will," "look forward"
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 additional funding to fully finance the planned
voreloxin pivotal trial, the risk that Sunesis' development
activities for voreloxin could be halted or significantly delayed
for various reasons, the risk that Sunesis' clinical studies for
voreloxin 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 voreloxin, and the risk that Sunesis' proprietary
rights may not adequately protect voreloxin. 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, 2010 and 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 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.
Investor and Media Inquiries: David Pitts Argot Partners
212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc.
650-266-3717
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