Sunesis Pharmaceuticals Presents Clinical Data on SNS-595 at the American Society of Clinical Oncology Annual Meeting
June 05 2006 - 8:30AM
PR Newswire (US)
ATLANTA, June 5 /PRNewswire-FirstCall/ -- Sunesis Pharmaceuticals,
Inc. (NASDAQ:SNSS) presented promising clinical data at the 42nd
Annual American Society of Clinical Oncology Meeting from two Phase
I studies evaluating once-weekly and once-every-three-week dosing
schedules of SNS-595 in patients with advanced solid malignancies.
In both trials, SNS-595 exhibited clinical activity across a
variety of tumor types among end-stage refractory patient
populations and was well-tolerated with manageable side effects.
Out of a total of 62 evaluable patients from both Phase I studies,
two patients achieved partial responses, another 17 patients
achieved stable disease for fifteen weeks or greater, with one
patient maintaining stable disease for more than a year. Patients
enrolled in both studies had advanced disease in a variety of tumor
types including ovarian, lung, colon, pancreatic and renal. All had
previously progressive disease at the time of enrollment despite
prior treatments. SNS-595 was well tolerated, with a dose-limiting
toxicity of reversible non-cumulative neutropenia. In addition,
SNS-595 demonstrated consistent and predictable pharmacokinetics
across both dosing regimens. "SNS-595 appears to possess several
compelling attributes. SNS-595 has been well tolerated to date, can
be dosed on convenient dosing schedules, and has shown evidence of
clinical activity across multiple tumor types," said Herbert
Hurwitz, M.D. Associate Professor of Medical Oncology and
Transplantation at Duke University. "We continue to be very pleased
by the demonstration of activity and safety in our Phase I studies
and these data helped in the design of our Phase II program. We are
currently conducting Phase II clinical studies of SNS-595 in
non-small cell and small-cell lung cancers, with another study
currently being planned for patients with ovarian cancer," said
Daniel C. Adelman, M.D., Senior Vice President, Research and
Development at Sunesis. "In addition, SNS-595's favorable
pharmaceutical properties and predictable pharmacokinetics across
different dose ranges to date support its potential both as a
monotherapy, as well as in combination with other chemotherapeutic
agents." Data were presented in a poster titled "SNS-595
demonstrates clinical activity and dose-proportional
pharmacokinetics (PK) in two phase I clinical studies," first
authored by Dr. Hurwitz during the Molecular Therapeutics poster
session on Sunday, June 4, 2006. The two Phase I studies were
designed to evaluate safety, tolerability, pharmacokinetics and
optimal dosing of SNS-595, Sunesis' lead anticancer drug candidate.
In the first study, SNS-595 was administered at doses ranging from
3-75 mg/m2 once every three weeks for up to six cycles among 41
patients with advanced solid tumors. In the second Phase I study,
21 patients with advanced cancers received SNS-595 weekly for three
weeks with one week off for up to six cycles in doses ranging from
3-24 mg/m2. The maximum-tolerated dose for SNS-595 administered
once every three weeks was 48 mg/m2 for heavily pre-treated
patients and 60 mg/m2 for minimally pre-treated patients and the
maximum-tolerated dose for once-weekly administration of SNS-595
for three weeks was 15 mg/m2. About SNS-595 SNS-595 is a promising
first-in-class cancer therapeutic currently in a Phase I acute
leukemia clinical trial and Phase II non-small cell and small cell
lung cancer clinical studies. SNS-595, a naphthyridine analog, has
a novel mechanism of action that selectively targets and kills
proliferating cells during the DNA replication phase of the cell
cycle. SNS-595 works through the DNA-protein kinase and p73
dependent pathways to induce apoptosis, or programmed cell death.
In clinical trials conducted to date, SNS-595 has been well
tolerated and has shown promising signs of clinical activity. In
earlier preclinical evaluation, SNS-595 demonstrated broad and
potent activity across xenograft, syngeneic and drug-resistant
models. 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/. Safe Harbor
Statement This press release contains forward-looking statements
that involve substantial risks and uncertainties. Sunesis may not
actually achieve the plans, intentions or expectations contained in
such forward-looking statements. Actual results or events could
differ materially from the plans, intentions and expectations
contained in such forward-looking statements. Sunesis does not
assume any obligation to update any such forward-looking
statements. DATASOURCE: Sunesis Pharmaceuticals, Inc. CONTACT:
investors, Eric Bjerkholt, CFO 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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