Sunesis Pharmaceuticals Focuses Resources on Development of Voreloxin (Formerly SNS-595)
04 June 2008 - 6:21AM
PR Newswire (US)
Development Leadership Team in Place to Advance Voreloxin to
Late-Stage Trials SOUTH SAN FRANCISCO, Calif., June 3
/PRNewswire-FirstCall/ -- Sunesis Pharmaceuticals, Inc.
(NASDAQ:SNSS) today announced a corporate realignment to focus on
the development of the company's lead oncology product candidate,
voreloxin (formerly SNS-595). In conjunction with this strategic
restructuring, Sunesis expanded the company's late-stage
development leadership team and announced a workforce reduction of
approximately 60 percent, including the winding down of its
research activities. These changes are intended to concentrate the
company's financial and human resources on the strongest path to
potential near-term value creation for the company's stockholders.
"Based on the promising clinical data achieved to date, we have
made a strategic decision to focus the organization on generating
critical clinical data by advancing our lead compound, voreloxin,
into late-stage trials in the acute myeloid leukemia and ovarian
cancer indications," said Daniel Swisher, Sunesis' Chief Executive
Officer. "Late-stage development requires increased focus of our
resources. We are also expanding and strengthening our development
team with the additions of Drs. Steve Ketchum and Mary Bolton.
Their extensive product development and regulatory expertise and
track records of successful FDA submissions in a breadth of
therapeutic areas will support our plan to advance voreloxin
through late-stage trials." Steven B. Ketchum, Ph.D., has been
appointed as Senior Vice President, Research and Development and
Mary G. Bolton, M.D., Ph.D., as Vice President, Clinical
Development. In addition, Judith A. Fox, Ph.D., has been promoted
to Vice President, Product and Preclinical Development and Glenn C.
Michelson, M.D., has been promoted to Vice President, Clinical
Strategy. To date, voreloxin has demonstrated objective responses
in both solid and hematologic tumors and has been consistently well
tolerated in multiple clinical trials. Sunesis is currently
conducting Phase 2 clinical trials of voreloxin as a single agent
for the treatment of platinum-resistant ovarian cancer and
previously untreated acute myeloid leukemia (AML), as well as a
Phase 1b clinical trial of voreloxin in combination with cytarabine
in relapsed/refractory AML. Data recently reported at the 44th ASCO
Annual Meeting in the Phase 2 ovarian cancer trial demonstrated
that 48 percent of platinum-resistant ovarian cancer patients
treated at a dose of 48 mg/m2 once every 21 days achieved disease
control, defined as stable disease for 90 days or more or a
complete or partial response. Preliminary median progression- free
survival in this group of patients was 13 weeks at this dose;
twenty- three patients at this dose remained on study as of May 12,
2008. Later this month, at the European Hematology Association
Congress, Sunesis will report updated data on voreloxin's activity
alone, and interim data on voreloxin's activity in combination with
cytarabine for the treatment of AML. Sunesis continues ongoing
trials in its earlier-stage clinical programs, including the Phase
1 dose-escalation study of its cyclin-dependent kinase inhibitor,
SNS-032, and its pan-Aurora kinase inhibitor, SNS-314, and expects
to report data from these clinical trials this year. The company
plans to seek a development partner to support advanced clinical
trials of SNS-314. Future development of SNS-032 will depend on
achieving positive results from the ongoing trial. With the closing
of its internal discovery research activities, Sunesis will also
explore opportunities to monetize the company's extensive fragment-
based drug discovery capabilities, its preclinical programs and/or
its intellectual property portfolio through a potential spin out or
strategic alliance. Sunesis will continue to benefit from any
down-stream milestones or royalties based on future progress made
in compounds emerging from its existing drug discovery
collaborations with Biogen Idec Inc., Johnson & Johnson
Pharmaceutical Research and Development LLC, Merck & Co., Inc.
and SARcode Corporation. Sunesis anticipates that one or more of
these compounds may advance to clinical trials within the next
twelve months. With this restructuring, Sunesis is reducing its
workforce by approximately 60 employees. In addition, executive
team members Daniel C. Adelman, M.D., Senior Vice President,
Development and Chief Medical Officer, William L. Schary, Ph.D.,
Vice President, Regulatory Affairs and Quality Assurance, Robert S.
McDowell, Ph.D., Vice President, Research and Jennifer A. Troia,
SPHR, Vice President, Human Resources and Corporate Operations,
will be leaving the company. Employees affected by the
restructuring will be eligible for a severance package that
includes severance pay, continuation of benefits and professional
outplacement services. A one-time charge of approximately $10.7
million is expected to be incurred in the second quarter of 2008.
Approximately $8.0 million of this charge is related to the closing
of the company's research facility. Approximately $2.5 million of
the restructuring charge represents cash payments over the next
twelve months for severance and other personnel related expenses.
"The decision to undertake this workforce reduction is a difficult
one. I deeply appreciate all of the past contributions made on
behalf of Sunesis by the talented and committed employees affected
by this realignment. I am confident that the ongoing team will
build upon their legacy as we aggressively advance voreloxin
through late-stage clinical studies," said Mr. Swisher. Actions
taken today will allow the company to direct most of its resources
into the late-stage development of voreloxin. Sunesis expects this
realignment of personnel and programs to reduce annual operating
expenses by more than $15 million, thus enabling increased
investment into such development. Current burn rate guidance for
the second half of 2008 is in the range of $12-15 million,
including payment of severance and other restructuring charges.
About Voreloxin (formerly SNS-595) Sunesis' lead compound,
voreloxin (formerly 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. Voreloxin
both intercalates DNA and inhibits topoisomerase II, resulting in
replication- dependent, site-selective DNA damage, irreversible G2
arrest and rapid apoptosis. Voreloxin is currently being evaluated
in a Phase 2 clinical trial (known as the REVEAL-1 trial) in
previously untreated elderly AML patients, in a Phase 1b clinical
trial combining voreloxin with cytarabine for the treatment of
patients with relapsed/refractory AML, and as a single agent in a
Phase 2 clinical trial in platinum-resistant ovarian cancer. In
clinical trials conducted to date, voreloxin has been generally
well tolerated and has shown objective responses in both solid and
hematologic tumor types. About Sunesis Pharmaceuticals Sunesis is a
clinical-stage biopharmaceutical company focused on the development
of new oncology therapeutics for the treatment of solid and
hematologic cancers. Sunesis has built a highly experienced cancer
drug development organization committed to advancing its lead
product candidate, voreloxin, in multiple indications to improve
the lives of people with cancer. For additional information on
Sunesis Pharmaceuticals, please visit http://www.sunesis.com/.
SUNESIS and the logo are trademarks of Sunesis Pharmaceuticals,
Inc. Safe Harbor Statement This press release contains
forward-looking statements including without limitation statements
related to the expected timing for completion of the restructuring
plan; estimated restructuring charges to be incurred by Sunesis in
the second quarter; anticipated benefits of the restructuring;
potential safety and efficacy and commercial potential of voreloxin
(formerly SNS-595); planned additional clinical testing and
development efforts for the company's programs; the timing of
enrollment in the ongoing Phase 2 clinical trial for voreloxin; the
timing of announcements of clinical results for the company's
programs; the company's plans to monetize the company's extensive
fragment- based drug discovery capabilities and/or intellectual
property portfolio; the advancement of compounds with the company's
collaboration partners to clinical trials in 2008; the anticipated
costs incurred by the company in connection with the restructuring;
and the company's anticipated burn rate for the second half of
2008. Words such as "promising," "supports," "optimistic," "look
forward," "expects" 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 or those of its partners, including
enrollment and reporting of results, could be halted significantly
or delayed for various reasons; the risk that Sunesis' clinical
trials for voreloxin or its other programs 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; the risk that Sunesis may not be
able to monetize its fragment-based drug discovery capabilities
and/or intellectual property portfolio; the risk that Sunesis'
restructuring costs may be greater than anticipated; the risk that
Sunesis' workforce reduction and any future workforce and expense
reductions may have an adverse impact on Sunesis' internal
programs, Sunesis' ability to hire and retain key personnel and may
be distracting to management; 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, 2007, Sunesis' Quarterly
Report on Form 10-Q for the quarter ended March 31, 2008 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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