-- Conference Call Scheduled for Today, Monday June 1, at 1:00 PM
ET to Discuss ASCO Data Presentations -- SOUTH SAN FRANCISCO,
Calif., June 1 /PRNewswire-FirstCall/ -- Sunesis Pharmaceuticals,
Inc. (NASDAQ:SNSS), announced today new data from three ongoing
clinical trials demonstrating that Sunesis' lead drug candidate,
voreloxin, shows promising safety and efficacy in acute myeloid
leukemia (AML) and in platinum-resistant ovarian cancer. These data
were presented today and this past weekend at the American Society
of Clinical Oncology 2009 Annual Meeting in Orlando. The
presentations are available on the Sunesis website at
http://www.sunesis.com/. "We have made significant progress with
our voreloxin program," said Daniel Swisher, Chief Executive
Officer of Sunesis. "Over 190 patients were enrolled across the
voreloxin trials in 2008. In AML, voreloxin, as a single agent or
when combined with cytarabine, has induced over 50 patients into a
complete remission to date. This positive momentum has carried into
2009 as we complete our current studies, prepare for our
End-of-Phase 2 meeting with the FDA and complete our plans for
entering into pivotal studies in AML." Phase 2 Study of Single
Agent Voreloxin in Newly Diagnosed Elderly AML (REVEAL-1 Trial)
REVEAL-1 (Response Evaluation of VorEloxin in AmL) is a Phase 2
dose regimen optimization study of single agent voreloxin in newly
diagnosed elderly AML patients who are unlikely to benefit from
standard induction chemotherapy. Interim clinical data from this
study continue to show that voreloxin can induce durable complete
remissions. -- In Schedule A (72 mg/m2 of voreloxin weekly for
three weeks), 29 patients have been enrolled and treated. -- 20 of
29 patients (69 percent) were 70 years of age or older. -- The
majority of patients had intermediate or unfavorable cytogenetics.
-- 12 patients achieved a complete remission (CR) or complete
remission without full platelet recovery (CRp) for an overall
remission rate of 41 percent. -- Eight of 12 responders received
one consolidation cycle of voreloxin and no responders received a
second consolidation cycle. -- Grade 3 or higher non-hematologic
adverse events occurring in more than 10 percent of patients
include mucosal inflammation, infections and fatigue. -- The 30-day
all-cause mortality rate was 17 percent, which compares favorably
to standard induction chemotherapy. Infection was the most common
cause of early mortality. -- In Schedule B (72 mg/m2 of voreloxin
dosed weekly for two weeks), 35 patients have been enrolled and
treated. -- 27 of 35 patients (77 percent) were 70 years of age or
older. -- The majority of patients had intermediate or unfavorable
cytogenetics. -- Data from these patients suggest that Schedule B
is better tolerated. The incidence of Grade 3 or higher mucosal
inflammation has been reduced by more than 50 percent relative to
Schedule A. The 30-day all-cause mortality has also been reduced to
9 percent. -- Anti-leukemic activity has been maintained. 10
patients achieved a CR or CRp for an overall remission rate of 29
percent. -- The number of responders receiving either one or two
consolidation cycles increased. All 10 responders received one
consolidation cycle of voreloxin and seven of 10 responders
received a second consolidation cycle. While still too early to
calculate, this may contribute to an improved median duration of
remission in Schedule B compared to Schedule A. -- In Schedule C
(72 mg/m2 of voreloxin dosed on days one and four), 28 patients
have been enrolled and treated. -- It is still too early for a
complete remission evaluation, but four CRs and two CRps of 19
evaluable patients have been achieved to date, while nine patients
are too early to evaluate. -- As with Schedule B, early data from
patients suggest that Schedule C is better tolerated than Schedule
A and activity has also been maintained. The 30-day all-cause
mortality is currently nine percent (two of 23). -- Based on the
current safety profile of 72 mg/m2 of voreloxin in Schedule C as
well as the ongoing Phase 1b/2 experience of 90 mg/m2 of voreloxin
dosed on days one and four in combination with cytarabine, an
additional cohort of approximately 20 patients will be enrolled at
90 mg/m2 in Schedule C. -- The median duration of remission and the
median overall survival have not yet been reached in any schedule.
-- In Schedule A, five of 12 responders remain in remission for
over seven months while four have relapsed and three have withdrawn
from remission follow-up. -- In Schedule B, nine of 10 responders
remain in remission to date. -- More than half of all patients in
Schedules A and B have survived more than six months. "Voreloxin's
anti-leukemic activity in this previously untreated, older adult
patient population with AML is promising," said Robert K. Stuart,
M.D., Professor of Medicine, Division of Hematology/Oncology,
Department of Medicine, Medical University of South Carolina, and
an investigator in the study. "I am encouraged by the complete
remissions observed thus far in patients who are unlikely to
benefit from standard induction therapy. Additionally, the
convenience of a ten minute injection is an added benefit for both
staff and patients." Phase 1b/2 Study of Voreloxin in Combination
with Cytarabine in Relapsed/Refractory AML Researchers also
presented interim data from an ongoing Phase 1b/2 clinical trial
testing voreloxin in combination with cytarabine. The Phase 1b/2
trial is designed to evaluate the safety, pharmacokinetics and
anti-leukemic activity of escalating doses of voreloxin when
administered on days one and four with cytarabine given either as a
continuous infusion of 400 mg/m2 daily for five days (CIV Schedule)
or as a two hour IV bolus of 1 g/m2 daily for five days (Bolus
Schedule). -- The Phase 1 dose escalation in both the CIV and Bolus
Schedules has been completed with a maximum tolerated
dose/recommended Phase 2 dose of 80 mg/m2 and 90 mg/m2,
respectively. -- Between both schedules, 57 relapsed or refractory
patients have been enrolled and treated in the dose escalation. --
In the Phase 1 portions of this study, infection related toxicities
were the most common Grade 3 or higher adverse events. The overall
incidence of Grade 3 or higher mucosal inflammation was 11 percent
when patients from both the CIV and Bolus Schedules are combined.
-- In the dose escalation, nine of 39 patients (23 percent) in the
CIV Schedule and four of 18 patients (22 percent) in the Bolus
Schedule achieved a CR or CRp. Responders included first relapse,
second relapse, primary refractory and relapsed/refractory
patients. -- In the CIV Schedule dose escalation, six of nine
responders to date have had a remission of at least eight months
and a third of responders went on to receive a bone marrow
transplant. -- It is too early to evaluate remission duration in
the Bolus Schedule dose escalation. -- Across both the CIV and
Bolus Schedules, a total of 14 patients with primary refractory AML
were enrolled and treated with a voreloxin dose of 80 mg/m2 or
higher. Five of 14 of these patients achieved a CR or CRp for an
overall CR or CRp rate of 36 percent, which compares favorably
relative to expected remission rates in this AML population of
approximately 10 to 15 percent. -- In Phase 2, 16 AML patients in
first relapse were enrolled in the CIV Schedule. -- Infection
related toxicities were the most common Grade 3 or higher adverse
events and no Grade 3 or higher mucosal inflammation was observed.
-- Six CRs and one CRp were achieved for an overall CR or CRp rate
of 44 percent, which compares favorably relative to the expected
single agent cytarabine remission rate of approximately 20 percent.
Five first relapse AML patients were enrolled in the dose
escalation in the CIV Schedule at a dose of 80 mg/m2 or higher, of
whom none achieved a CR or CRp. -- Three of seven responders had an
initial remission, or CR1, of less than 12 months, and to date,
five of seven responders remain in remission. -- In the Bolus
Schedule, both first relapse and primary refractory patients are
currently being enrolled in Phase 2. "Voreloxin has demonstrated
anti-leukemic activity when administered in combination with both
continuous infusion and bolus cytarabine," said Jeffrey Lancet,
M.D, Assistant Professor and Section Chief of the Leukemia Program,
Division of Hematologic Malignancies at the H. Lee Moffitt Cancer
Center & Research Institute, and an investigator in this
voreloxin/cytarabine combination study in AML. "Voreloxin has
induced remissions in several difficult to treat AML patient
populations, including relapsed, primary refractory and
relapsed/refractory AML patients. I look forward to the final
results of this study and the continued clinical investigation of
voreloxin." Phase 2 Study of Single Agent Voreloxin in Women with
Platinum-Resistant Ovarian Cancer Updated clinical data from the
Phase 2 study of single agent voreloxin in women with
platinum-resistant ovarian cancer were also presented at the ASCO
2009 Annual Meeting. Platinum resistance is defined as progression
within six months of completing platinum-based chemotherapy or
progression while on platinum-based chemotherapy. Patients may have
received up to three prior platinum regimens plus one additional
non-platinum cytotoxic regimen. Approximately a third of the study
patients have also failed prior treatment with Doxil(R). -- Three
dose cohorts of voreloxin have been studied, 48 mg/m2 given every
three weeks (N=65), 60 mg/m2 given every four weeks (N=37) and 75
mg/m2 given every four weeks (N=35). Enrollment completed in
December of 2008. 16 patients in the 60 mg/m2 and 75 mg/m2 cohorts
remain on study. -- Data from this trial show encouraging durable
anti-tumor activity across all three dose cohorts. The overall
response rate (ORR), as measured by GOG RECIST criteria, was eleven
percent for each of the three dosing cohorts: two complete
responses (CR) and five partial responses (PR) in cohort A (48
mg/m2 q3 weeks), two CRs and two PRs in cohort B (60 mg/m2 q4
weeks) and four PRs in cohort C (75 mg/m2 q4 weeks). -- 74 patients
(52 percent) experienced disease control, defined as an objective
response or stable disease for 12 weeks or more. -- The median
progression free survival (PFS) for cohort A was 82 days. The
preliminary median PFS for cohorts B and C is 84 days and 109 days,
respectively. There was a significant difference in PFS among the 3
dose cohorts (p = 0.019). PFS was significantly longer in the 60
and 75 mg/m2 cohorts vs. 48 mg/m2, suggesting a benefit to higher
voreloxin doses. -- Four PRs were achieved in the 44 women who were
Doxil(R) failures for an ORR of nine percent and 28 (64 percent)
achieved disease control. -- The preliminary median PFS in these
Doxil(R) failure patients is 90 days. PFS was not statistically
different from those who had not failed Doxil(R). -- Overall, the
adverse event profile was similar across cohorts and voreloxin was
generally well-tolerated. Grade 3 or higher adverse events
occurring in more than 10 percent of patients include neutropenia,
febrile neutropenia, and anemia. -- The incidence of febrile
neutropenia was increased in cohort C (75 mg/m2 q4 weeks), and was
clinically manageable and within the range of other commonly used
and approved agents in ovarian cancer. "Voreloxin continues to
demonstrate promising clinical activity in a vastly underserved
patient population," said Robert P. Edwards, M.D., Professor of
Obstetrics, Gynecology, and Reproductive Sciences and Vice Chair of
the Division of Gynecologic Oncology at the University of
Pittsburgh, and an investigator for the Phase 2 clinical trial. "I
am encouraged by the preliminary data, including the activity in
patients that are resistant or refractory to both platinum-based
chemotherapy and Doxil(R)." Conference Call Information Sunesis
management, joined by voreloxin clinical investigators, will host a
conference call to discuss the voreloxin clinical data presented at
the ASCO 2009 Annual Meeting today, Monday, June 1, 2009, at 1:00
p.m. ET / 10:00 a.m. PT. Individual and institutional investors can
access the call via 1-877-856-1961 (U.S. and Canada) or
+1-719-325-4787 (international). To access the live audio webcast
or the subsequent archived recording, visit the "Investors and
Media - Calendar of Events" section of the Sunesis website at
http://www.sunesis.com/. The webcast will be recorded and available
for replay on the company's website until June 15, 2009. About
Voreloxin Voreloxin is a first-in-class anticancer quinolone
derivative, or AQD, a class of compounds that 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, G2 arrest and
apoptosis. Voreloxin is currently being evaluated in a Phase 2
clinical trial (known as the REVEAL-1 trial) in previously
untreated elderly AML patients and in a Phase 1b/2 clinical trial
combining voreloxin with cytarabine for the treatment of patients
with relapsed/refractory AML, as well as in an ongoing Phase 2
single agent trial in platinum-resistant ovarian cancer. About
Acute Myeloid Leukemia AML is a rapidly progressing cancer of the
blood characterized by the uncontrolled proliferation of immature
blast cells in the bone marrow. The Leukemia and Lymphoma Society
estimates that over 13,000 new cases of AML were diagnosed and
approximately 9,000 deaths from AML occurred in the U.S. during
2007. AML is generally a disease of older adults, and the median
age of a patient diagnosed with AML is about 67 years. A majority
of elderly patients are not considered candidates for standard
induction therapy or decline therapy, resulting in an acute need
for new treatment options. 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 were 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 biopharmaceutical company
focused on the development and commercialization 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/. This press release contains
forward-looking statements, including without limitation statements
related to the potential safety and efficacy and commercial
potential of voreloxin, the efficacy and benefits of voreloxin as
compared to currently available treatments, planned additional
clinical testing and development efforts and the timing of
interactions with regulatory authorities . Words such as "shows,"
"suggest," "will," "promising," "activity," "demonstrated,"
"encouraged," "preliminary," "continues" 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, risks related to
Sunesis' need for additional funding, the risk that Sunesis' drug
development activities could be halted significantly or delayed for
various reasons, the risk that Sunesis' clinical trials for
voreloxin 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'
nonclinical 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, including the pace of
enrollment, risks related to the manufacturing of voreloxin and the
risk that Sunesis' proprietary rights may not adequately protect
voreloxin. These and other risk factors are discussed under "Risk
Factors" and elsewhere in Sunesis' Annual Report on Form 10-K/A for
the year ended December 31, 2008, its quarterly report on Form 10-Q
for the quarter ended March 31, 2009 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. SUNESIS and the logo are
trademarks of Sunesis Pharmaceuticals, Inc. All other trademarks
are the property of their respective owners. Investor Contact:
Media Contact: Sunesis Pharmaceuticals, Inc. Sunesis
Pharmaceuticals, Inc. Eric Bjerkholt Dan Weinseimer 650-266-3717
650-266-3739 DATASOURCE: Sunesis Pharmaceuticals, Inc. CONTACT: For
investors, Eric Bjerkholt, +1-650-266-3717, for media, Dan
Weinseimer, +1-650-266-3739, both of Sunesis Pharmaceuticals, Inc.
Web Site: http://www.sunesis.com/
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