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Cytel Paves the Way for New Era of Innovative Trial Designs with Release of East 6.5

December 14, 2018

Cambridge, MA, Dec. 14, 2018 (GLOBE NEWSWIRE) -- Cytel Inc., a global provider of advanced analytical solutions to the pharmaceutical, biotechnology, and medical device industries, today announced the launch of East® version 6.5, further enhancing the most trusted technology platform for designing, monitoring, and simulating adaptive trials. Since 1995, East has empowered trial sponsors of all sizes to optimize study planning and monitoring efforts, accelerate timelines, and increase their probability of success in clinical development.

Cyrus Mehta, Co-Founder of Cytel and a Fellow of the American Statistical Association said, “For almost three decades, Cytel has pioneered adaptive trial methods and we have demonstrated their enormous potential to unlock better outcomes in drug development. The FDA’s recent launch of its Complex Innovative Designs (CID) Pilot Meeting Program is just one signal of increasing regulatory support for new design strategies that can pave the way for the next era of medical advancement. The recent release of the new FDA draft guidance for adaptive designs also represents a shift in regulatory thinking that reflects the increased industry track record and experience in these methods. We are proud that our continued development of East’s functionality enables our biotechnology and pharmaceutical customers to robustly and efficiently put the most promising innovative trial design methods into practice.”

The upgraded version of East unveils new modules MCPMod (for dose-finding trials using MCPMod methodology); ENRICH (for simulating a population enrichment design with a survival endpoint); and PROGRAM for optimizing a clinical development program using frequentist or Bayesian go/no-go rules. The upgrades also incorporate a range of enhancements to the platform’s overall user interface and various new features within established modules including ESCALATE, MAMS, and PREDICT.

Yannis Jemiai, Senior Vice President of Software and Consulting at Cytel added, “The enhancements in East 6.5 have been developed in collaboration with our strategic consulting customers to address a number of their most pressing drug development concerns. The new ENRICH and PROGRAM modules particularly reflect the concerns of drug developers in the oncology and rare disease space where it is critical to make the best possible use of scarce data, at a program as well as at a trial level. Selection of the right dose for confirmatory phase 3 trials continues to be one of the biggest headaches in drug development and the MCPMod module will help our customers more easily put the EMA- qualified dose-finding methodology into practice, and use available data in the most effective manner.”

The new functionality encompasses:

MCPMod (Design and Analysis with Multiple Comparisons Procedures) The European Medicines Agency (EMA) has qualified the Multiple Comparison Procedure – Modeling (MCP-Mod) approach as an efficient statistical methodology for design and analysis of phase 2 dose-finding studies under model uncertainty. East MCPMod allows for the design and analysis of such studies for normal, binomial, and count endpoints, with a variety of candidate models, dose selection criteria, and optimal allocations.

ENRICH supports the simulation of clinical trial designs with adaptation options for population enrichment, while strongly controlling type-1 error rate. It provides flexibility in defining the promising zone for sample size increase, and an enrichment zone for subgroup selection. It was specially developed for oncology trials with time to event endpoints.

PROGRAM simulates a sequence of clinical trials within an oncology program. One can simulate a dose escalation trial (3+3, mTPI, CRM, BLRM, from East ESCALATE) followed by a cohort expansion phase. Alternatively, PROGRAM allows users to simulate one single-arm Phase 2 trial followed by a two-arm Phase 3 trial. Both approaches allow for the incorporation of flexible go/no-go rules to support decision-making.

About East®

East® 6.5 is the industry standard platform for clinical trial design, simulation, and monitoring. East improves scientific productivity during the critical planning stages of clinical development, by providing a comprehensive design environment that implements adaptive designs in line with regulatory guidance. Efficient workflows and high-quality outputs reduce barriers to learning and collaboration to enable more impactful quantitative decisionmaking. More information about East is available at https://www.cytel.com/software/east

For East product or sales queries from existing or prospective customers contact sales@cytel.com

About Cytel

As a pioneer in evidence generation, with deep expertise in advanced analytical solutions, Cytel is uniquely equipped to unlock the value from increasingly complex data. Life sciences companies count on Cytel to deliver exceptional insight, minimize trial risk and accelerate the development of promising new medicines that improve human life. Cytel provides data-focused clinical research services and software solutions for the design and analysis of clinical trials, including industry standards East®, StatXact®, and LogXact®. With operations across North America, Europe, and India, Cytel employs 900 professionals, with strong talent in biostatistics, programming, data science, and data management. For more information about Cytel, visit http://www.cytel.com/

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-- East

Liz Cole Cytel Inc. + 1 617 9879402 liz.cole@cytel.com

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