Sunesis
Pharmaceuticals, Inc. (Nasdaq: SNSS) announced that patient dosing
has commenced in clinical trials to evaluate two of the company's
anti-cancer product candidates, SNS-595 and SNS-314.
Sunesis' lead product candidate, SNS-595, is being evaluated in
combination with cytarabine in a Phase 1b clinical trial of patients with
relapsed and/or refractory acute leukemias. This clinical trial is designed
to evaluate the safety, tolerability and initial indications of anti-cancer
activity of escalating doses of SNS-595 when administered with a fixed dose
of cytarabine. Non-clinical studies demonstrated that SNS-595 acts
synergistically with cytarabine, the current standard of care in acute
leukemias.
SNS-314, an Aurora kinase inhibitor, is being studied in its first
clinical trial. The Phase 1 dose-escalating trial of SNS-314 in patients
with advanced solid malignancies will examine safety and tolerability, as
well as preliminary anti-tumor activity. The open-label trial is being
conducted by leading investigators at five U.S. clinical sites. Patients in
this trial will receive three once-weekly doses of SNS-314 per four-week
cycle. In non-clinical studies, SNS-314 demonstrated robust anti-tumor
activity in tumor models of diverse tissue types.
"We are pleased to have these two trials up and running. In addition to
the single-agent activity we've observed for SNS-595 in acute leukemia
patients, SNS-595 has demonstrated impressive synergy with cytarabine in
non-clinical studies. Testing the potential benefits of a combination
regimen is a key element of our comprehensive strategy to develop SNS-595
for the treatment of acute leukemia," said Daniel C. Adelman, M.D., Senior
Vice President, Development and Chief Medical Officer at Sunesis.
"We're also excited to be treating patients for the first time with
SNS-314, our internally discovered Aurora kinase inhibitor. SNS-314 has
shown broad anti-tumor activity across a number of tumor models, and
selective and specific activity against Aurora kinases in non-clinical
studies," Dr. Adelman continued.
About SNS-595
SNS-595 is currently in Phase 1 and Phase 1b acute leukemia clinical
trials and a Phase 2 ovarian cancer clinical trial. SNS-595 is a
replication- dependent DNA damaging agent that causes irreversible growth
arrest of proliferating cells and rapid apoptosis. In clinical trials
conducted to date, SNS-595 has been well tolerated and has shown promising
signs of clinical activity in both solid and hematological tumor types. In
non- clinical evaluations, SNS-595 demonstrates broad and potent activity
in xenograft, syngeneic and drug-resistant models.
About SNS-314
Discovered by Sunesis using the company's discovery platform, SNS-314
is a potent and selective inhibitor of Aurora kinases A, B and C. SNS-314
targets the uncontrolled cellular proliferation associated with cancer by
halting cell division at the mitotic phase of the cell cycle. Aurora
kinases are key enzymes involved in cancer cell division and have a central
role in the abnormal proliferation of tumors.
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
sunesis.
Other Information
In August, Ms. Karen Terrick joined Sunesis as a Director, Regulatory
Affairs. In conjunction with her joining, the Compensation Committee of the
company's Board of Directors approved an employment commencement grant to
Ms. Terrick of a non-qualified stock option to purchase 25,000 shares of
Sunesis common stock, effective August 31, 2007. This option award was
granted without shareholder approval pursuant to Nasdaq Marketplace Rule
4350 (i)(1)(A)(iv) and with the following material terms: (a) an exercise
price equal to the fair market value of the company's common stock on the
grant date, (b) a term of ten years, and (c) a vesting schedule providing
that the option is exercisable as to one-quarter of the total grant on the
first anniversary of Ms. Terrick's hire, and one-forty-eighth of the total
grant each month thereafter until the grant is fully vested.
Safe Harbor Statement
This press release contains forward-looking statements, including
without limitation statements related to the safety, tolerability and
potential efficacy of SNS-595 (alone and in combination with cytarabine)
and SNS-314, planned clinical testing and development efforts and the
anticipated clinical sites and timing of clinical trials. Words such as
"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, Sunesis' drug discovery, development and clinical manufacturing
activities could be halted or significantly delayed, Sunesis' clinical
trials for SNS-595 and SNS-314 may not demonstrate safety or efficacy or
lead to regulatory approval, Sunesis' preclinical studies and clinical
trials may not satisfy the requirements of the FDA or other regulatory
agencies and Sunesis may require substantial additional funding, which may
not be available to us on acceptable terms, or at all. 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, 2006 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.
Sunesis Pharmaceuticals, Inc.
sunesis