UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant
to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 6, 2014
SUNESIS PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
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000-51531 |
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94-3295878 |
(State or other jurisdiction
of incorporation) |
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(Commission
File Number) |
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(IRS Employer
Identification No.) |
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395 Oyster Point Boulevard, Suite 400
South San Francisco, California |
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94080 |
(Address of principal executive offices) |
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(Zip Code) |
Registrants telephone number, including area code: (650) 266-3500
Not Applicable
(Former
name or former address, if changed since last report.)
Check the appropriate box below
if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 8.01. Other Events.
On October 6, 2014, Sunesis Pharmaceuticals, Inc. issued a press release announcing the results from its Phase 3, multinational,
randomized, double-blind, placebo-controlled, pivotal clinical trial of vosaroxin in combination with cytrabine in patients with relapsed or refractory acute myeloid leukemia. A copy of the press release issued concerning the foregoing is furnished
herewith as Exhibit 99.1 and is incorporated herein by reference.
The press release is furnished and shall not be deemed
filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained
herein and in the accompanying exhibit shall not be incorporated by reference into any filing with the Securities and Exchange Commission made by Sunesis, whether made before or after the date hereof, regardless of any general incorporation language
in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit No. |
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Description |
99.1 |
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Press release, dated October 6, 2014, entitled Sunesis Announces Results from Pivotal Phase 3 VALOR Trial of Vosaroxin and Cytarabine in Patients with First Relapsed or Refractory Acute Myeloid Leukemia. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
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SUNESIS PHARMACEUTICALS, INC. |
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Dated: October 6, 2014 |
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By: |
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/s/ Eric H. Bjerkholt |
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Eric H. Bjerkholt |
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Executive Vice President, Corporate Development and Finance, Chief Financial Officer and Corporate Secretary |
EXHIBIT INDEX
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Exhibit No. |
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Description |
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99.1 |
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Press release, dated October 6, 2014, entitled Sunesis Announces Results from Pivotal Phase 3 VALOR Trial of Vosaroxin and Cytarabine in Patients with First Relapsed or Refractory Acute Myeloid Leukemia. |
Exhibit 99.1
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Investor and Media Inquiries: David
Pitts Argot Partners 212-600-1902 |
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Eric Bjerkholt Sunesis Pharmaceuticals,
Inc. 650-266-3717 |
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Sunesis Announces Results from Pivotal Phase 3 VALOR Trial of Vosaroxin and Cytarabine in Patients with
First Relapsed or Refractory Acute Myeloid Leukemia
Trial Does Not Reach Primary Endpoint of Statistically Significant
Improvement in Overall Survival
Shows Significant Survival Benefit when Censored for Transplant
Safety Profile Consistent with that Observed in Previous Company Trials
Company Plans to Commence European Filing and Explore U.S. Regulatory Pathway
Sunesis to Host Conference Call and Webcast Today at 8:30 AM Eastern Time
SOUTH SAN FRANCISCO, Calif., October 6, 2014 Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) today announced results from the pivotal Phase 3
VALOR trial, a randomized, double-blind, placebo-controlled trial of vosaroxin and cytarabine in patients with first relapsed or refractory acute myeloid leukemia (AML). At more than 100 leading international sites, the trial enrolled 711 patients,
who were stratified for age, geography and disease status. The trial did not meet its primary endpoint of demonstrating a statistically significant improvement in overall survival, with a median overall survival of 7.5 months for vosaroxin and
cytarabine compared to 6.1 months for placebo and cytarabine (HR=0.865, p=0.06). Because transplant may confound the primary analysis, a predefined analysis of overall survival censoring for stem cell transplantation was planned. In this analysis,
patients receiving the vosaroxin combination had a median overall survival of 6.7 months versus 5.3 months for placebo and cytarabine (HR=0.809, p=0.02). The trial also demonstrated a clinically significant benefit in complete remission (CR) rate
(30.1% vs 16.3%, p=0.0000148), the secondary endpoint.
For age, the trial stratified patient populations into age 60 years and older and younger than 60
years at enrollment. Within a predefined analysis of patients younger than 60 years (n=260), where the rate of stem cell transplant was 45.8%, the vosaroxin combination demonstrated a median overall survival of 9.1 months, versus 7.9 months for
placebo and cytarabine (HR=1.079, p=NS), and a CR rate of 26.9% versus 20.8% (p=0.24). In the analysis of patients aged 60 years and older (n=451), where the rate of stem cell transplant was 20.2%, the vosaroxin combination demonstrated a median
overall survival of 7.1 months, versus 5.0 months for placebo and cytarabine (HR=0.755, p=0.006), and a CR rate of 31.9% versus 13.8% (p=0.0000048).
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In the intent-to-treat population, Grade 3 or higher non-hematologic adverse events that were more common in the
vosaroxin combination arm were gastrointestinal and infection-related toxicities, consistent with those observed in previous company trials. The rate of serious adverse events was 55.5% in the vosaroxin combination arm compared to 35.7% in the
placebo and cytarabine arm. Thirty-day and 60-day all-cause mortality were comparable between the trial arms (7.9% versus 6.6% and 19.7% versus 19.4%, for the vosaroxin combination versus placebo and cytarabine, respectively).
Based on results of the trial, Sunesis plans to commence a marketing authorization application with the European Medicines Agency (EMA) and to meet with the
U.S. Food and Drug Administration to determine the appropriate regulatory path forward.
The results reported above are based upon Sunesis analysis
of the data to date. Detailed results of the VALOR trial will be submitted for presentation at an upcoming medical conference.
VALOR was a robust,
well-conducted trial, among the largest in the relapsed or refractory AML setting. The study outcomes are very encouraging, and I look forward to a full presentation of the data in a peer-reviewed forum, said Robert Stuart, M.D., Professor of
Medicine, Division of Hematology/Oncology, Department of Medicine, Medical University of South Carolina, an investigator in the VALOR study and chairman of the studys steering committee. The clinical benefit is particularly impressive in
patients aged 60 years and older, a population for whom there is no therapeutic standard of care.
There remains an acute need for new
treatment options in AML, particularly relapsed refractory patients, where no therapy has demonstrated a survival benefit in a pivotal Phase 3 trial in more than 40 years, said Adam Craig, M.D., Ph.D., Executive Vice President, Development and
Chief Medical Officer of Sunesis. While we continue to evaluate the findings of VALOR in their totality, we believe the results demonstrate a clinically meaningful and important advancement in the treatment of this disease.
We are deeply grateful for the support and commitment of the AML investigators, the patients and families who took part in or contributed to
VALOR, said Daniel Swisher, Chief Executive Officer of Sunesis. We look forward to presenting these data in detail to regulators in both Europe and the U.S. and to reporting on our progress and plans as they develop.
Conference Call and Webcast Information
Sunesis will
host a conference call today, October 6, 2014, at 8:30 a.m. Eastern Time. The call can be accessed by dialing (866) 953-6856 (U.S. and Canada) or (617) 399-3480 (international), and entering passcode 37368874. To access the
live audio, or the subsequent archived recording, visit the Investors and Media - Calendar of Events section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on Sunesis
website for two weeks.
About QINPREZO (vosaroxin)
QINPREZO (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer.
Preclinical data demonstrate that QINPREZO both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European
Commission have granted orphan drug designation to
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QINPREZO for the treatment of AML. Additionally, QINPREZO has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with
cytarabine. QINPREZO is an investigational drug that has not been approved for use in any jurisdiction.
The trademark name QINPREZO is conditionally
accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.
About AML
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The American
Cancer Society estimates there will be approximately 18,860 new cases of AML and approximately 10,460 deaths from AML in the U.S. in 2014. Additionally, it is estimated that the prevalence of AML across major global markets (U.S., France, Germany,
Italy, Spain, United Kingdom and Japan) is over 50,000. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. AML patients with relapsed or refractory disease and newly diagnosed AML
patients over 60 years of age with poor prognostic risk factors typically die within one year, resulting in an acute need for new treatment options for these patients.
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, vosaroxin, in multiple indications to improve the lives of people with cancer.
For additional information on
Sunesis, please visit http://www.sunesis.com.
SUNESIS and the logos are trademarks of Sunesis Pharmaceuticals, Inc.
This press release contains forward-looking statements, including statements related to Sunesis regulatory strategy (including plans to commence a
marketing authorization filing with the EMA), Sunesis preliminary analysis, assessment and conclusions of the results of the VALOR trial, and the efficacy and commercial potential of vosaroxin. It is possible that such results or conclusions
may change based on further analysis of the VALOR data. Words such as plans, intends, will, believe, 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 preliminary analysis, assessment and conclusions of the results of the VALOR trial set forth in this release may change based on
further analysis of such data, the risk that Sunesis plans to commence a marketing authorization filing with the EMA may change or such filing may be rejected by the EMA, and the risk that Sunesis clinical studies for vosaroxin may not
lead to regulatory approval. 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, 2013, and Sunesis other filings with the
Securities and Exchange Commission, including Sunesis Quarterly Report on Form 10-Q for the quarter ended June 30, 2014. 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 Sunesis expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
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