Sunesis Pharmaceuticals Reports Positive Interim Data for SNS-595 Single-Agent Activity in Platinum-Resistant Ovarian Cancer
March 10 2008 - 7:00AM
PR Newswire (US)
SOUTH SAN FRANCISCO, Calif., March 10 /PRNewswire-FirstCall/ --
Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS), a clinical-stage
biopharmaceutical company focused on the discovery, development and
commercialization of novel small-molecule therapeutics, today
announced positive interim data from the company's ongoing Phase 2
clinical trial of its lead product candidate, SNS-595, in
platinum-resistant ovarian cancer patients. In this Phase 2
clinical trial, single agent SNS-595 has demonstrated disease
control (defined as stable disease, partial response or complete
response) in 31 of 35 patients evaluable for best response using
GOG-RECIST criteria. Of these 31 patients, one patient had a
complete response, four patients had partial responses (two
unconfirmed) and 26 patients had a best response of stable disease.
All patients enrolled in the trial have previously failed treatment
with platinum-containing regimens, and fourteen of the 35 patients
have also failed prior treatment with doxorubicin HCl liposome
injection (Doxil(R)). Both platinum-resistant and Doxil-resistant
patients in the Phase 2 clinical trial have responded to SNS-595
therapy. "Recurrence rates among ovarian cancer patients remain
high, and the majority of refractory patients are resistant to
platinum-based therapies. Based on these interim data, SNS-595
appears to be a promising, active agent in a difficult-to-treat
ovarian cancer patient population," said William P. McGuire, M.D.,
Medical Director of the Harry and Jeanette Weinberg Cancer
Institute at Franklin Square, and a lead investigator for the Phase
2 trial. Among forty-five patients with sufficient follow-up to
yield safety data, SNS-595 was generally well tolerated at a dose
level of 48mg/m2 administered once every three weeks. The most
common adverse events reported thus far include nausea, fatigue,
vomiting and alopecia. There was a low rate of febrile neutropenia
or other Grade 3/4 adverse events, and manageable Grade 1/2 nausea
or vomiting. Based on the indications of clinical activity and the
acceptable tolerability profile demonstrated to date among this
patient population, the dose of SNS-595 in this trial has been
increased to 60 mg/m2 over twenty-eight days. Patient accrual at
this dose level is ongoing. "We are pleased by the strong signal of
activity emerging from our Phase 2 clinical trial of SNS-595 at the
48mg/m2 dose level. Based on the drug's observed safety profile and
recommendations from advisors, we are exploring a higher dose of
SNS-595 in this trial. Enrollment has begun at 60 mg/m2 and we
expect to enroll approximately 30 patients at this dose by the
third quarter of this year," said Daniel C. Adelman, M.D., Senior
Vice President, Development and Chief Medical Officer of Sunesis.
"Enthusiasm for SNS-595 among our clinical investigators is growing
and enrollment in this trial has been accelerating. We expect to
present further data from this Phase 2 clinical trial this year."
The interim clinical results are being presented in a poster, "A
Phase 2 Trial of SNS-595 in Women with Platinum-Refractory
Epithelial Ovarian Cancer" (Abstract # 290), at the 39th Annual
Meeting on Women's Cancer hosted by the Society of Gynecologic
Oncologists (SGO) in Tampa, Fla. through March 12, 2008. About
SNS-595 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. SNS-595 is a specific DNA
intercalator and topoisomerase II poison, causing
replication-dependent site-selective double strand DNA damage,
irreversible G2 arrest and rapid apoptosis. In non-clinical
evaluations, SNS-595 demonstrates broad and potent activity in
xenograft, syngeneic and drug-resistant models. In addition to the
Phase 2 clinical trial in ovarian cancer patients, SNS-595 is
currently being evaluated in combination with cytarabine in a Phase
1b acute leukemia clinical trial. In clinical trials conducted to
date, SNS-595 has been generally well tolerated and has shown
objective responses in both solid and hematologic tumor types.
About Ovarian Cancer In the United States, ovarian cancer remains
the leading cause of death from gynecologic malignancies and is the
fifth leading cause of cancer death overall in women behind lung,
breast, colorectal and pancreatic cancers. According to the
American Cancer Society, in 2008 there will be an estimated 21,650
new cases and more than 15,000 deaths from ovarian cancer in the
U.S. alone. Following frontline treatment, recurrence rates among
ovarian cancer patients are high. Treatment options remain limited
following relapse and overall long-term survival has not changed
significantly over the past 40 years, with five-year survival rates
at less than 30 percent. 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. Other trademarks are the property of
their respective owners. Safe Harbor Statement This press release
contains forward-looking statements including without limitation
statements related to the potential safety and efficacy and
commercial potential of SNS-595, planned additional clinical
testing and development efforts, the timing of enrollment in the
ongoing Phase 2 clinical trial and the announcement of clinical
results. Words such as "look forward," "suggests," "may," "plans,"
"expects," "appears" 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 SNS-595 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 SNS-595 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, 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 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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