Sunesis Pharmaceuticals Announces Presentation of Updated Results from Washington University-Sponsored Phase 1/Cohort Expansi...
June 23 2017 - 7:00AM
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the
presentation of updated results from a Washington
University-sponsored Phase 1/Cohort Expansion trial of vosaroxin
plus azacitidine in patients with myelodysplastic syndrome (MDS).
The results are being presented today from 5:15 to 6:45 P.M.
Central European Time in a poster session titled “Myelodysplastic
syndromes – Clinical 1” at the 22nd Congress of the European
Hematology Association (EHA) being held at the IFEMA - Feria de
Madrid in Madrid, Spain. The poster (abstract P319, Hall 7), titled
“Vosaroxin Plus Azacitidine Treatment for Patients with
Myelodysplastic Syndrome (MDS): A Phase 1/Cohort Expansion Study,”
will be available following the presentation
at www.sunesis.com.
"While hypomethylating agents are a mainstay of
treatment for myelodysplastic syndromes, these agents alone produce
remissions in a minority of patients and are not curative,"
said Meagan A. Jacoby, M.D., Ph.D., Assistant
Professor, Division of Oncology, Washington University
School of Medicine, and principal investigator of the study. “The
combination of vosaroxin and azacitidine shows promising activity
in this Phase 1/Cohort Expansion study, with response rates and
transplant rates in this study that are better than those observed
with azacitidine alone, particularly in an older patient
population. We look forward to additional follow up from this
study.”
In this open label, dose-escalation trial
sponsored by the Washington University School of Medicine,
patients with MDS who may have received up to three prior cycles of
hypomethylating agent-based therapy were given vosaroxin and
azacitidine for of six cycles. The Phase 1 portion of the study was
designed to determine the maximum tolerated dose for use in the
expansion portion of the study.
Thirteen patients were enrolled in the
dose-escalation phase and 22 patients were enrolled in the
expansion cohort. The maximum tolerated dose (MTD) of vosaroxin in
patients with MDS was determined to be 34 mg/m2 administered on
Days 1 and 4 in combination with 75 mg/m2 azacitidine on Days 1
through 7; this dose regimen was studied in the Phase 2 cohort.
The major non-hematologic toxicities of febrile
neutropenia, infections, and mucositis were expected based on the
disease population and prior experiences with vosaroxin. The
dose-limiting toxicities at 50 mg/m2 vosaroxin were
hyperbilirubinemia and neutropenia (both Grade 4); at 34 mg/m2
vosaroxin, 1 of 6 patients experienced a DLT of Grade 4 mucositis.
Two deaths were considered possibly treatment-related (sepsis, n=1;
diffuse alveolar hemorrhage, n=1). No cardiac toxicity attributable
to study treatment was observed, even with prolonged therapy.
Of the 35 patients enrolled to the study, 32
completed ≥1 cycle and were evaluable for response. Among evaluable
patients, the median number of total cycles completed was 3 (range:
1-18), with 3 still continuing therapy. Best response was as
follows: CR, n=8, marrow complete remission (CR), n=5; marrow CR
with HI-platelets; n=3; marrow CR with HI-neutrophil, n=3; marrow
CR with HI-erythroid, n=1; marrow CR with HI-platelets and
neutrophils, n=1; and stable disease n=10. One patient had
progressive disease (PD). Sixteen have proceeded to allogeneic stem
cell transplant and 3 are actively undergoing study treatment.
Additional data is expected on secondary endpoints and from
correlative studies.
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/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. Currently, the company is focused on advancing its
novel kinase-inhibitor pipeline, which includes its proprietary
non-covalent BTK-inhibitor, SNS-062.
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 the continued
development and commercialization of vosaroxin, the timing of our
Phase 1b/2 trial of SNS-062, and the sufficiency of Sunesis’ cash
and funding into June 2018. Words such as “advance,”
“continue,” “expect,” “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 SNS-062 or
vosaroxin could be otherwise halted or significantly delayed for
various reasons, risks related to Sunesis' need for substantial
additional funding to complete the development and
commercialization of vosaroxin and other product candidates,
including SNS-062, the risk that Sunesis' clinical studies for
vosaroxin or other product candidates, including SNS-062 or 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 timing or conduct of Sunesis' clinical trials, 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 SNS-062, 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 March 31, 2017 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:
Maeve Conneighton
Argot Partners
212-600-1902
Dan Swisher
Sunesis Pharmaceuticals Inc.
650-266-3715
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