Sunesis Pharmaceuticals Initiates Phase II Clinical Trial of SNS-595 in Small Cell Lung Cancer
March 20 2006 - 7:30AM
PR Newswire (US)
SOUTH SAN FRANCISCO, Calif., March 20 /PRNewswire-FirstCall/ --
Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) today announced that
patient treatment has commenced in a Phase II clinical trial of
SNS-595, the company's lead anti-cancer therapeutic, in patients
with small cell lung cancer. The trial is an open-label,
multi-center study designed to examine the safety and efficacy of
SNS-595 as a second-line agent in patients with small cell lung
cancer who have failed first-line therapy. SNS-595 is a
first-in-class cell-cycle modulator that (in vitro) kills
proliferating cancer cells by inducing apoptosis, or programmed
cell death, as cells progress through the S phase of the cell
cycle. "Sunesis continues to demonstrate rapid progress in the
advancement of multiple oncology products through development. This
Phase II study in small cell lung cancer -- our second Phase II
trial for SNS-595 -- is the fourth clinical trial we have initiated
since last fall," said Daniel N. Swisher, President and Chief
Executive Officer at Sunesis. "Through these studies, we are
learning more about the promising anticancer activity of our two
lead oncology candidates." "Small cell lung cancer makes up
approximately sixteen percent of lung cancers, and is characterized
by rapid growth and spread, and commonly relapses within months of
treatment," said Daniel Adelman, M.D., Senior Vice President of
Research and Development at Sunesis. "First-line treatment for
small cell lung cancer typically involves use of a platinum drug
such as cisplatin in combination with a second agent, typically
etoposide. While these chemotherapies are beneficial, most
patients' disease recurs. We believe that SNS-595 has the potential
to provide a meaningful benefit in second-line treatment as we have
observed evidence of SNS-595's activity in platinum-resistant and
etoposide-resistant xenograft models." Patients with small cell
lung cancer who have failed first-line treatment will be enrolled
at multiple centers in the United States and Canada. Eligible
patients will receive SNS-595 every three weeks at a dose and
schedule identified in Sunesis' Phase I study of SNS-595 in
patients with advanced solid malignancies. The trial design
anticipates enrolling 80 patients -- 40 that are refractory and 40
that are sensitive. According to the American Cancer Society, in
2006, approximately 160,000 people will die of lung cancer and
approximately 174,000 new cases will be diagnosed in the U.S.
alone. Of these, approximately sixteen percent will be small cell
lung cancer. Small cell lung cancer is estimated to affect
approximately 34,000 patients in the U.S. alone with 29,000 new
cases diagnosed each year. Characterized by the small round cells
that make up small cell lung cancer tumors, this form of lung
cancer tends to spread widely through the body as cells multiply
quickly, forming large tumors and spreading to the lymph nodes and
other organs. Small cell lung cancer is almost always associated
with smoking. About SNS-595 SNS-595 is a first-in-class cytotoxic
with a novel mechanism of action. SNS-595 acts during the S phase
of the cell cycle to induce rapid apoptosis of cells that are
actively synthesizing DNA. Sunesis is currently conducting an
open-label Phase II clinical study of SNS-595 in patients with
non-small cell lung cancer and a Phase I dose escalation safety
clinical study in patients with acute leukemias. In clinical trials
conducted to date, SNS-595 has been well tolerated and has shown
promising signs of clinical activity. In addition, SNS-595 has
exhibited broad activity in xenograft studies and drug-resistant
tumor 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. 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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