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Sunesis Pharmaceuticals to Implement One-Time Sample Size Increase to Phase 3 VALOR Trial in AML
Sep 11, 2012 (GlobeNewswire via COMTEX) --
DSMB Recommends Increase Following Single, Pre-Planned Interim Efficacy and Safety Analysis of VALOR; Enrollment Completion Expected in 2013
DSMB Recommendation Triggers $25.0 Million Investment in Sunesis from Royalty Pharma
Sunesis to Host Conference Call Today at 9:00 AM Eastern Time
SOUTH SAN FRANCISCO, Calif., Sept. 11, 2012 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. SNSS-22.35% today announced that it will implement a one-time, 225-patient sample size increase to its Phase 3 VALOR trial of vosaroxin in acute myeloid leukemia (AML), bringing target enrollment to 675 patients. This is in response to the recommendation of the trial's independent Data and Safety Monitoring Board (DSMB) following their completion yesterday of a single, pre-planned interim analysis of unblinded efficacy and safety data sets from VALOR.
VALOR is a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial of vosaroxin in patients with first relapsed or refractory AML. The pre-planned sample size increase of 225 additional patients is designed to maintain adequate statistical power over a broader range of survival outcomes. With the revised target sample size of 675 patients, Sunesis anticipates full enrollment of VALOR in 2013, with unblinding of the trial expected in the first half of 2014 upon reaching 562 events and final database lock. The DSMB recommendation also triggers Royalty Pharma's obligation to invest $25.0 million in Sunesis.
"The completion of VALOR's interim analysis is an important milestone for Sunesis," said Daniel Swisher, Chief Executive Officer of Sunesis. "In light of the design of VALOR, the DSMB's recommendation that we implement a one-time, 225-patient sample size increase is a promising development. We thank the DSMB for their comprehensive analysis, and trial investigators for their continued support of VALOR, which has now enrolled 412 patients. Importantly, we are pleased that we have committed funding that will allow us to implement this enrollment expansion and complete the pivotal trial in AML."
Sunesis' management and staff, VALOR clinical investigators, including members of the Study Steering Committee, and Royalty Pharma remain blinded to the interim trial data and analysis.
Royalty Pharma's $25.0 million investment is made pursuant to the terms of an agreement with Sunesis announced March 29, 2012. In exchange for their investment, Royalty Pharma will receive a 6.75% royalty on future net sales of vosaroxin and warrants to purchase Sunesis common stock.
Sunesis Pharmaceuticals, Inc. has added a news release to its Investor Relations website.
Title: Sunesis Announces Publication of Vosaroxin Phase 3 VALOR Trial Results in The Lancet Oncology
Date(s): 4-Aug-2015 4:03 PM
For a complete listing of our news releases, please click here
SOUTH SAN FRANCISCO, Aug. 4, 2015 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that results from the Company's Phase 3 VALOR trial of vosaroxin and cytarabine in 711 patients with relapsed or refractory acute myeloid leukemia (AML) were published in the The Lancet Oncology. The VALOR results were first announced by the company on October 6, 2014. The article, titled "Vosaroxin plus cytarabine versus placebo plus cytarabine in patients with first relapsed or refractory acute myeloid leukaemia (VALOR): a randomised, controlled, double-blind, multinational, phase 3 study" is available online first at http://www.thelancet.com/journals/lanonc/article/...)00201-6/abstract and will appear in the September 2015 print issue of The Lancet Oncology.
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