Innovative “Promising Zone” approach for Sunesis Pharmaceuticals’ VALOR study utilized in phase 3 development of Acute Myeloid Leukemia treatment
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Cytel Inc., a leading provider of adaptive clinical trial services and statistical software, in conjunction with Sunesis Pharmaceuticals, today announced the immediate availability for download of the jointly authored Sunesis VALOR trial poster presented at the June 2011 American Society of Clinical Oncology (ASCO) Annual Meeting. The PDF is now accessible to all from this cytel.com link.
Cytel President and Co-Founder Dr. Cyrus Mehta said of the ASCO viewing session success “more and more sponsors are confidently staging sample size re-estimation-based designs, where we begin to realize the promise of adaptive trials toward increasing the likelihood of deploying better treatments to especially those suffering from severe diseases like AML.”
Sponsor companies together with international regulatory agencies are increasingly embracing adaptive methods for confirmatory (phase 3) trials especially in light of Cytel’s “Promising Zone” strategy as it enables conditional trial resource investments in pre-determined stages. Starting with a modest initial sample size commitment, additional patients are added only if justified by the interim analysis results.
With the increasing validation of the practical innovations delivered in Cytel adaptive trial methodologies, (detailed in this poster PDF) Cytel’s work continues with numerous other oncology, CNS, metabolic and cardio-vascular biopharmaceutical developers on adaptive trial designs in both early and late stage clinical research.
VALOR is a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial in patients with first relapsed or refractory AML. In 2010, The American Cancer Society estimated that 12,330 AML cases were diagnosed with 9,000 attributable deaths in the U.S. The trial employs an innovative adaptive trial design that allows for a one-time sample size adjustment at the interim analysis to maintain adequate power across a range of clinically meaningful and statistically significant survival outcomes. Complete information at www.valortrial.com.
All 25 leading global biopharmaceutical companies use Cytel technology to design, simulate and analyze their clinical studies. Pioneers of the supporting statistical methods, every adaptive trial designed by Cytel has been accepted by international regulators.
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Michael Weitz, 617-528-7132
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