Sunesis Presents Results From Phase I Clinical and Preclinical Studies of SNS-595 at American Association for Cancer Research M
April 04 2006 - 8:30AM
PR Newswire (US)
SNS-595 Was Well Tolerated With Promising Signs of Clinical
Activity WASHINGTON, April 4 /PRNewswire-FirstCall/ -- Sunesis
Pharmaceuticals, Inc. (NASDAQ:SNSS) presented clinical and
preclinical data on the company's lead compound, SNS-595 at the
Annual Meeting of the American Association for Cancer Research
(AACR). In a poster titled "A Phase 1 trial of weekly SNS-595 in
patients with refractory cancer," (abstract # 2074), Sunesis
reported data from a dose-escalating clinical study of 21 patients
with advanced solid tumors designed to examine the safety,
tolerability and pharmacokinetics of a weekly dosing regimen.
SNS-595 demonstrated promising signs of clinical activity, with 6
of 21 patients, or almost one-third, experiencing sustained disease
control lasting at least 16 weeks, including a confirmed partial
response at the maximum-tolerated dose in a patient with
mesothelioma. SNS-595 was well tolerated; a dose-limiting toxicity
of neutropenia was observed while other side effects were mild and
consistent with the results from the company's prior Phase I study.
Sunesis is currently conducting two Phase II clinical studies of
SNS-595 among non-small cell lung cancer and small cell lung cancer
patients, as well as a Phase I dose-escalation clinical study in
patients with acute leukemias. The acute leukemia study is
exploring two dose regimens, with weekly and twice-weekly dosing.
"SNS-595 appears to be a promising cancer therapeutic with a number
of compelling characteristics. In two Phase I clinical studies in
patients with a variety of advanced solid tumors, we have seen
encouraging clinical activity, including two confirmed partial
responses, and sustained disease control in almost one-third of the
patients," said Daniel C. Adelman, M.D., Senior Vice President,
Research and Development at Sunesis. "In addition, SNS-595 shows
potential in both solid and hematologic tumors and we are
encouraged by the compelling data from our clinical and preclinical
studies that help inform our ongoing and future clinical trials."
Sunesis also presented SNS-595 preclinical data further elucidating
the compound's mechanism of action and demonstrating that SNS-595
acts synergistically with a wide variety of chemotherapeutic agents
in vitro and exhibits potent activity in vivo against hematologic
malignancies. SNS-595 was found to be synergistic when combined
with a number of chemotherapeutic drugs, including DNA-damaging
agents, antimetabolites and an Hsp90 inhibitor, geldanamycin. In
addition, preclinical studies of SNS-595 demonstrating potent
anti-proliferative activity in human leukemic cell lines were used
in the development of Sunesis' current Phase I clinical study among
patients with acute leukemias. 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 napthyridine 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' Oncology Programs In addition to SNS-595,
Sunesis has built a portfolio of preclinical- and development-stage
product candidates in oncology focused on novel pathways and
targets, including inhibition of the cell cycle and survival
signaling. SNS-032 is in a Phase I/II clinical study to examine the
safety and preliminary anti-tumor activity among patients with a
variety of solid tumors, including lung cancer, breast cancer or
melanoma. SNS-032 is a potent and selective inhibitor of
cyclin-dependent kinases 2, 7 and 9. Sunesis is currently
conducting preclinical studies of its Aurora kinase inhibitor drug
candidate, SNS-314. In addition, in cooperation with Biogen Idec,
Sunesis is developing novel small molecule inhibitors of Raf kinase
and other oncology kinases. 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.
Forward-Looking Statements This press release may contain
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. For further
information on Sunesis Pharmaceuticals, please visit
http://www.sunesis.com/ . 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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