Sunesis Issued Important European Patent Covering Vosaroxin Clinical Formulation
10 Marzo 2011 - 6:30AM
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSSD) today announced that
the European Patent Office (EPO) has granted European Patent No.
1725233, claiming the Company's pharmaceutical compositions of lead
drug candidate vosaroxin. Sunesis is proceeding to validate this
patent in multiple EPO member states. The resulting national
patents would expire on March 14, 2025, but could be eligible for
patent term extension beyond this date. A related United States
patent was granted in 2010, and related patent applications are
pending in other major markets throughout the world including
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
pivotal Phase 3 VALOR trial in relapsed/refractory AML," stated
Daniel Swisher, Chief Executive Officer of Sunesis. "Supplementing
protection for our vosaroxin development program with new patents
having life out 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."
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 leading sites in the U.S., Canada, Europe, Australia
and New Zealand. VALOR 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 VALOR please visit www.valortrial.com.
The VALOR logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=8774
About Vosaroxin (Formerly Voreloxin)
Vosaroxin, formerly known as 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. Vosaroxin
both intercalates DNA and inhibits topoisomerase II, resulting in
replication-dependent, site-selective DNA damage, G2 arrest and
apoptosis. Sunesis is currently enrolling patients in 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.
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 estimates that 12,330 new
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 Pharmaceuticals, 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 without limitation statements related to the prosecution
of patent applications and Sunesis' ability to execute the pivotal
Phase 3 VALOR trial in first relapsed or refractory AML. Words such
as "provides," "expect," "look forward," "pursuing," "extend" 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 VALOR
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,
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 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.
CONTACT: Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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