Sunesis Pharmaceuticals Announces First Patient Treated in Vanderbilt University-Sponsored Phase 2 VITAL Study of Vosaroxin i...
March 24 2016 - 6:00AM
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that
the first patients have been treated in the investigator-sponsored
VITAL (
Vosaroxin and
Infusional
Cytarabine for Frontline
Treatment of
Acute Myeloid
Leukemia) Phase 2
study of vosaroxin in combination with cytarabine in patients with
previously untreated acute myeloid leukemia (AML). The trial is
being conducted at the Vanderbilt-Ingram Cancer Center at
Vanderbilt University under the direction of Michael R. Savona,
M.D., FACP, Associate Professor of Medicine and Director of
Hematology Early Therapeutics Program, and Stephen A. Strickland,
M.D., MSCI, Assistant Professor of Medicine.
“With an alarming rate of mortality in AML and
no major change in induction therapy strategy for nearly four
decades, there is an urgent need to find novel therapeutic
strategies for this disease,” said Dr. Strickland. “Given the
established, acceptable safety profile of infusional cytarabine
given concomitantly with vosaroxin, this combination offers a new
approach for achieving remission in this population. It also
provides the opportunity to expand upon the previously observed
efficacy of vosaroxin in patients with relapsed/refractory AML and
has the potential to serve as a foundation for a future randomized
Phase 3 trial.”
VITAL, a single-arm, open-label Phase 2 trial
will enroll up to 61 previously untreated, newly diagnosed adult
patients with AML. During stage 1 of the trial, 17 patients will be
enrolled. The study design permits one interim look to examine
evidence of futility after the first 17 patients are evaluable for
response. If ≤ 7 patients achieve complete remission (CR),
the VITAL DSMB will review the clinical data to determine the
merits of continued enrollment. If > 7 CRs are observed,
the second stage will open automatically and increase enrollment to
41 patients. During both stages, Vosaroxin will be administered
intravenously at 90 mg/m2 on days 1 and 4. Cytarabine will be
administered in standard fashion as a continuous infusion of 100
mg/m2 daily on days 1-7.
Patients with evidence of residual leukemia on
“Day 14 biopsy” following initial induction will be offered
re-induction with intravenous vosaroxin at 70 mg/m2 on days 1 and 4
in combination with continuous infusion cytarabine at 100 mg/m2
daily on days 1-7. The primary endpoint of the study is rate of CR.
The secondary endpoints are to determine the safety and
tolerability, presence of minimal residual disease, CR (including
CR with incomplete blood count recovery), neutrophil and platelet
recovery, disease free survival (DFS), overall survival (OS), and
the correlation of HSCT comorbidity index and Wheatley index scores
with disease response, DFS and OS.
“VITAL is the third investigator-sponsored
combination trial of vosaroxin in frontline AML, and an important
component of establishing our future development strategy in this
setting,” said Daniel Swisher, Chief Executive Officer of Sunesis.
“We look forward to seeing results from these studies, which
include two other leading institutions, MD Anderson and Indiana
University, as we make progress on the review of our European
Marketing Authorization Application for vosaroxin as a treatment
for relapsed/refractory AML.”
About QINPREZO™ (vosaroxin)
QINPREZO™ (vosaroxin) is an anti-cancer
quinolone derivative (AQD), a class of compounds that has not been
used previously for the treatment of cancer. Preclinical data
demonstrate that vosaroxin both intercalates DNA and inhibits
topoisomerase II, resulting in replication-dependent,
site-selective DNA damage, G2 arrest and apoptosis. Both
the U.S. Food and Drug Administration (FDA)
and European Commission have granted orphan drug
designation to vosaroxin for the treatment of AML. Additionally,
vosaroxin has been granted fast track designation by
the FDA for the potential treatment of relapsed or
refractory AML in combination with cytarabine. Vosaroxin is an
investigational drug that has not been approved for use in any
jurisdiction.
The trademark name QINPREZO is conditionally
accepted by the FDA and the EMA as the proprietary name
for the vosaroxin drug product candidate.
About Sunesis
Pharmaceuticals
Sunesis is a biopharmaceutical company focused
on the development and commercialization of new oncology
therapeutics for the potential treatment of solid and hematologic
cancers. Sunesis has built a highly experienced cancer drug
development organization committed to improving the lives of people
with cancer and is currently pursuing regulatory approval
in Europe for its lead product candidate, vosaroxin, for
the treatment of relapsed or refractory acute myeloid leukemia in
patients aged 60 and older. In addition, the company is advancing
its kinase-inhibitor pipeline of novel targeted therapies into the
clinic.
For additional information on Sunesis, please
visit http://www.sunesis.com.
SUNESIS and the logos are trademarks
of Sunesis Pharmaceuticals, Inc.
This press release contains forward-looking
statements, including statements related to Sunesis' estimated
timelines for regulatory interactions and regulatory progress,
including the anticipated progress and potential approval of
vosaroxin by the EMA, clinical development of SNS-062; Sunesis'
overall strategy in Europe and other major regions and
plans to gain marketing approval of vosaroxin in the U.S., the
design, conduct and results of clinical trials, including the
expected progress in its kinase inhibitor pipeline, and potential
advancements of SNS-229 to an IND, the need for and the role of
vosaroxin as a potential new treatment option, and the sufficiency
of Sunesis' cash resources. Words such as "expect," “look forward,”
"potential," "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, the risk that Sunesis may not be able
to receive regulatory approval of vosaroxin in the U.S.
or Europe, that Sunesis' development activities for vosaroxin
could be otherwise halted or significantly delayed for various
reasons, the risk that Sunesis' clinical studies for vosaroxin or
other product candidates, including its pipeline of kinase
inhibitors, 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, risks related to the
conduct of Sunesis' clinical trials, risks related to Sunesis' need
for substantial additional funding to complete the development and
commercialization of vosaroxin and other product candidates, and
risks related to Sunesis' ability to raise the capital that it
believes to be accessible and is required to fully finance the
development and commercialization of vosaroxin and other product
candidates. 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, 2015, Sunesis' Annual
Report on Form 10-K for the year ended December 31, 2015, when
available, and Sunesis' 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 Sunesis' expectations with regard thereto or
any change in events, conditions or circumstances on which any such
statements are based.
Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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