Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSSD) today announced that
vosaroxin, the Company's lead drug candidate, has been granted Fast
Track designation by the U.S. Food and Drug Administration (FDA)
for the potential treatment of relapsed or refractory acute myeloid
leukemia (AML) in combination with cytarabine.
The Fast Track designation process was developed by the FDA to
facilitate the development and expedite the review of new therapies
that are intended to treat serious or life-threatening conditions
and that demonstrate the potential to address unmet medical needs.
Specifically, Fast Track designation allows for the possibility of
a "rolling submission," or submission of individual sections as
they become available, for a marketing application and provides
eligibility for a priority (six month) review period by the
FDA.
Vosaroxin was granted orphan drug designation by the FDA for the
treatment of AML in 2009. Orphan drug designation is granted by the
FDA Office of Orphan Drug Products to novel drugs or biologics that
treat a rare disease or condition affecting fewer than 200,000
patients in the U.S. The designation provides eligibility for a
seven-year period of market exclusivity in the U.S. after product
approval and an exemption from user fees.
Patients with first relapsed or refractory AML are currently
enrolling in a Phase 3 trial of vosaroxin, known as VALOR. The
VALOR trial is a multinational, randomized, double-blind,
placebo-controlled, pivotal trial of vosaroxin in combination with
cytarabine, which is expected to enroll 450 evaluable patients at
leading sites in the U.S., Canada, Europe, Australia and New
Zealand.
"Vosaroxin's Fast Track designation, along with its orphan drug
designation, highlights the urgent need for new therapeutic options
for patients with first relapsed or refractory AML," stated Daniel
Swisher, Chief Executive Officer of Sunesis. "We are encouraged by
the initial roll out of the VALOR trial and are highly focused on
its successful prosecution. We look forward to opening new sites
around the world and rapidly and efficiently accruing patients into
VALOR."
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
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, please visit
http://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 progress
of the VALOR trial. Words such as "encouraged," "expected," "look
forward to," "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, risks and uncertainties related to
Sunesis' need for substantial additional funding to complete the
development and commercialization of vosaroxin, the risk that
unfavorable economic and market conditions may make it more
difficult and costly to raise additional capital, 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.
Risk factors related to Sunesis and its business 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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