Sunesis Pharmaceuticals Initiates Phase 2 Clinical Trial of Voreloxin (SNS-595) in Acute Myeloid Leukemia
May 21 2008 - 7:00AM
PR Newswire (US)
SOUTH SAN FRANCISCO, Calif., May 21 /PRNewswire-FirstCall/ --
Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) today announced the
initiation of the REVEAL-1 (Response Evaluation of Voreloxin in
Elderly AML) Phase 2 clinical trial of voreloxin (also known as
SNS-595), the company's lead anti-cancer therapeutic. The REVEAL-1
trial is being conducted in previously untreated elderly patients
with acute myeloid leukemia (AML) who are unlikely to benefit from
standard induction therapy. The first patient was enrolled and
treated at the Indiana University Melvin and Bren Simon Cancer
Center under the care of Larry D. Cripe, M.D., Associate Professor,
Department of Medicine, Division of Hematology/Oncology at the
Indiana University School of Medicine. The primary objective of the
REVEAL-1 trial is to evaluate voreloxin's anti-leukemic activity as
a single agent, measured as either complete remission (CR) or
complete remission without full platelet recovery (CRp). The study
will also measure the duration of these responses. In order to
qualify for the trial, patients must be at least age 60 with
previously untreated AML and satisfy at least one of the following
factors: poor performance status (PS 2); intermediate or
unfavorable cytogenetics; prior antecedent hematologic disorder; or
age greater than or equal to 70 years. Patients enrolled in the
trial will receive three weekly doses of 72 mg/m2 of voreloxin in a
treatment cycle. Approximately 55 patients will be enrolled in the
open-label, multi-center REVEAL-1 trial. "We are pleased to move
our voreloxin program forward in AML with this Phase 2 trial. Based
on the clinical activity and tolerability profiles observed in our
Phase 1 trial of voreloxin in relapsed/refractory AML patients, we
see a clear opportunity for this drug in the first-line treatment
of older patients who may not benefit from standard induction
therapy," said Daniel C. Adelman, M.D., Senior Vice President,
Development and Chief Medical Officer of Sunesis. "Treatment
options for elderly AML patients are extremely limited. If the data
from this trial indicate clear clinical benefit, Sunesis could
initiate a pivotal trial in this highly underserved patient
population. We expect to present interim data from this trial at a
medical conference toward the end of this year." Sunesis previously
reported promising results from its Phase 1 single agent
dose-escalation study of voreloxin in relapsed or refractory AML
patients. In that trial, 13 of 30 patients (43 percent) who
received doses of voreloxin of 50 mg/m2 or greater on a weekly dose
schedule achieved bone marrow blast reductions to less than five
percent, and five of those 13 achieved either CR, CRp or complete
remission with incomplete recovery of normal hematopoietic blood
elements. Voreloxin was generally well tolerated, with a
dose-limiting toxicity of reversible oral mucositis. A maximum-
tolerated weekly dose of 72 mg/m2 was established. Sunesis also
announced today that voreloxin has been accepted as the
nonproprietary name for SNS-595 by the United States Adopted Names
(USAN) Council, in consultation with the World Health Organization
(WHO) International Nonproprietary Names Expert Committee. Although
voreloxin has been officially accepted by the USAN Council, the
official adoption date has been set for May 28, 2008. The USAN
Council serves health professionals in the United States by
selecting simple, informative, and unique nonproprietary names for
drugs by establishing logical nomenclature classifications based on
pharmacological and/or chemical relationships to ensure that drug
information is communicated accurately and unambiguously. The USAN
Council aims for global standardization and unification of drug
nomenclature by working closely with the International
Nonproprietary Name Programme of WHO and various national
nomenclature groups. About Voreloxin (SNS-595) Voreloxin (also
known as SNS-595) is a novel naphthyridine analog, structurally
related to quinolones, a class of compounds which has not been used
previously for the treatment of cancer. Voreloxin both intercalates
DNA and inhibits topoisomerase II, resulting in
replication-dependent, site- selective DNA damage, irreversible G2
arrest and rapid apoptosis. The topoisomerase II-associated DNA
intercalation and DNA damage produced by voreloxin show greater
selectivity for proliferating cells. In nonclinical evaluations,
voreloxin demonstrates broad and potent activity in tumor biopsies
and in xenograft, syngeneic and drug-resistant tumor models. In
addition to the REVEAL-1 Phase 2 clinical trial in elderly AML
patients, voreloxin is being evaluated in combination with
cytarabine in a Phase 1b clinical trial and as a single agent in a
Phase 2 clinical trial in platinum-resistant ovarian cancer. In
clinical trials conducted to date, voreloxin has been generally
well tolerated and has shown objective responses in both solid and
hematologic tumor types. 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 over 13,000 new
cases of AML will be diagnosed and approximately 8,800 deaths from
AML will occur in the U.S. during 2008. AML is generally a disease
of older adults and the median age of a patient with AML is about
67 years. A majority of elderly patients are not considered
candidates for standard therapy or decline therapy, resulting in an
acute need for new treatment options. About Sunesis Pharmaceuticals
Sunesis is a clinical-stage biopharmaceutical company focused on
the discovery, development and commercialization of novel small
molecule therapeutics for oncology and other serious diseases.
Sunesis has built a broad product candidate portfolio through
internal discovery and in-licensing of novel cancer therapeutics.
Sunesis is advancing its product candidates through in-house
research and development efforts and strategic collaborations with
leading pharmaceutical and biopharmaceutical companies. For
additional information on Sunesis Pharmaceuticals, please visit
http://www.sunesis.com/. SUNESIS and the logo are trademarks of
Sunesis Pharmaceuticals, Inc. Safe Harbor Statement This press
release contains forward-looking statements including without
limitation statements related to the ongoing clinical testing of
voreloxin, potential safety and efficacy and commercial potential
of voreloxin, planned additional clinical testing and development
efforts, the timing of enrollment of patients in the company's
clinical trials, the adoption of voreloxin as a nonproprietary name
and the announcement of clinical results. Words such as "expect,"
"will," "opportunity," "plans," "could," 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' drug discovery and development activities, including
enrollment and reporting of results, could be halted significantly
or delayed for various reasons, the risk that Sunesis' clinical
trials for voreloxin may not demonstrate safety or efficacy or lead
to regulatory approval, the risk that preliminary data and trends
may not be predictive of future data or results, the risk that
Sunesis' preclinical studies and clinical trials may not satisfy
the requirements of the FDA or other regulatory agencies, risks
related to the conduct of Sunesis' clinical trials and
manufacturing of voreloxin and risks related to Sunesis' need for
additional funding. These and other risk factors are discussed
under "Risk Factors" and elsewhere in Sunesis' annual report on
Form 10-K for the year ended December 31, 2007 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. DATASOURCE: Sunesis
Pharmaceuticals, Inc. CONTACT: Investors, Eric Bjerkholt SVP, Corp.
Development & Finance of Sunesis Pharmaceuticals, Inc.,
+1-650-266-3717; or Media, Karen L. Bergman, +1-650-575-1509, or
Michelle Corral, +1-415-794-8662, both of BCC Partners, for Sunesis
Pharmaceuticals, Inc. Web site: http://www.sunesis.com/
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