Sunesis Issued Important U.S. Patent Covering Vosaroxin Clinical Formulation
November 15 2010 - 7:30AM
Marketwired
Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today announced that
the United States Patent and Trademark Office (USPTO) has granted
U.S. Patent No. 7,829,577, claiming the Company's pharmaceutical
compositions of lead drug candidate vosaroxin. This patent is
scheduled to expire on March 14, 2025, and could be eligible for
patent term extension beyond this date. Corresponding patent
applications are pending in major markets throughout the world
including Europe, Japan, Australia and Canada.
"This patent is an important new addition to our intellectual
property estate, as it covers the formulation currently used in our
clinical trials," stated Daniel Swisher, Chief Executive Officer of
Sunesis. "Vosaroxin's extended patent life to 2025 increases not
only the value of our AML franchise but also provides sufficient
time for lifecycle evaluation of vosaroxin in other indications. We
are pursuing a sophisticated and deliberate strategy to extend
exclusive coverage in the vosaroxin patent estate beyond 2025. In
addition to our granted patents, we have filed patent applications
covering additional 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 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. Vosaroxin 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 vosaroxin 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 been completed. Sunesis plans to initiate the VALOR trial,
a multinational, randomized, double-blind, placebo-controlled,
pivotal Phase 3 clinical trial of vosaroxin in combination with
cytarabine in a relapsed/refractory AML patient population, in the
fourth quarter of this year.
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 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 vosaroxin in the fourth quarter 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
vosaroxin pivotal trial, the risk that Sunesis' development
activities for vosaroxin could be 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 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
September 30, 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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