Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced
participation in a Phase 2/3 randomized, controlled, multicenter
trial evaluating novel treatment regimens against low dose
cytarabine (LD Ara-C), a commonly used treatment of elderly
patients with acute myeloid leukemia (AML) and high-risk
myelodysplastic syndrome (MDS). This trial, known as the Less
Intensive 1 (LI-1) Study, is being conducted by the United
Kingdom's National Cancer Research Institute (NCRI) Haematological
Oncology Study Group under the direction of Professor Alan K.
Burnett, Head of Haematology, Department of Medical Genetics,
Haematology & Pathology at Cardiff University School of
Medicine. Two regimens containing Sunesis' lead drug
candidate, vosaroxin, have been selected as investigational
treatment arms in this study.
The LI-1 study employs what is termed a "Pick a Winner" trial
design, as described in the journal Blood (R. Hills, A. Burnett,
2011 118: 2389-2394), and is designed to efficiently evaluate a
number of promising investigational treatments versus LD Ara-C in
elderly AML or MDS patients who are not candidates for intensive
chemotherapy. The trial will enroll patients over
the age of 60 with AML or high-risk MDS and randomize them to one
of a number of treatment regimens: LD Ara-C (control); single-agent
vosaroxin; vosaroxin combined with LD Ara-C; or to other
experimental therapies considered for inclusion in the
comparison. The current highlights of the protocol can be
found at http://www.controlled-trials.com/ISRCTN40571019.
All treatment options will be evaluated in a randomized Phase 2
design with key endpoints including complete remission (CR), 12
month survival, and overall survival. There is an initial
target of at least 50 patients entering each comparative arm.
Treatment arms that are exhibiting promising results on the basis
of CR or survival parameters are expected to continue enrolling
into a Phase 3 portion of the trial with up to a total of 200
patients enrolled per arm with a primary endpoint of overall
survival. There is the potential to treat up to 400 newly
diagnosed AML and high-risk MDS patients with a vosaroxin
containing induction regimen in the LI-1 trial, either as a
single-agent or combined with LD Ara-C.
"An enduring lack of options exists for the treatment-intolerant
elderly AML and MDS patient, creating a significant need for the
development of therapies that are both effective and tolerable,"
stated Professor Burnett. "The 'Pick a Winner' design provides
a platform for rapidly assessing new treatments that have the
potential to make clinically useful improvements in this
challenging disease. In a prior study, single-agent vosaroxin has
demonstrated anti-leukemic activity and favorable tolerability in
elderly AML patients. Vosaroxin has also showed a good
activity/tolerability profile in combination with cytarabine in a
relapsed/refractory patient population, which is a synergy that we
previously showed in the lab. These outcomes provide the
rationale for incorporating two vosaroxin arms into the LI-1
study."
"The inclusion of vosaroxin in this groundbreaking study is
important validation of the results from our Phase 2 REVEAL-1 trial
of single-agent vosaroxin in newly diagnosed elderly AML patients
with poor prognostic factors," stated Daniel Swisher, Chief
Executive Officer of Sunesis. "This trial allows for the
continued development of vosaroxin in this underserved patient
population, while we focus our internal resources on the completion
of our pivotal Phase 3 VALOR trial of vosaroxin in first relapsed
or refractory AML patients."
REVEAL-1 Trial in Elderly AML Patients
The REVEAL-1 trial, a Phase 2 dose optimization trial of
single-agent vosaroxin, evaluated 113 previously untreated, elderly
AML patients who were unlikely to benefit from standard induction
chemotherapy. In the trial, 82 percent of patients had two or more
adverse risk factors, including age greater than 70, intermediate
or unfavorable cytogenetics, and secondary AML. Median age for
patients in the trial was 74 years. The REVEAL-1 trial included
three dosing schedules. As previously reported, for Schedule C (72
mg/m2 of vosaroxin on days one and four), median overall survival
was 7.7 months, one year survival was approximately 38%. The 30-
and 60-day all-cause mortality rates were 7% and 17%,
respectively. The most common grade 3 or higher
non-hematologic adverse events included reversible upper GI mucosal
inflammation and infection.
About Vosaroxin
Vosaroxin is a first-in-class anti-cancer quinolone derivative,
(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.
About AML
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 there will be
12,950 new cases of AML and approximately 9,050 deaths from AML in
the U.S. in 2011. 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
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 results of
the LI-1 trial, the execution of the VALOR trial, and
vosaroxin's efficacy and safety profile as a single agent and
in combination with cytarabine. Words such as "participation,"
"promising," "provide," "selected," "evaluate," "expected,"
"continue," "significant," "need," "rapidly," "demonstrated" 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 results of these risks and
uncertainties, which include, without limitation, risks related to
Sunesis' need for substantial additional funding to complete the
development and commercialization of vosaroxin, risks related to
Sunesis' ability to raise the capital that it believes to be
accessible and is required to fully finance the VALOR trial, the
risk that raising funds through lending arrangements may restrict
our operations or produce other adverse results, the risk that
Sunesis' development activities for vosaroxin could be otherwise
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 supply of the
active pharmaceutical ingredients required for the conduct of the
VALOR trial, 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,
2011, Sunesis' Annual Report on Form 10-K for the year ended
December 31, 2010 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 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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