Cytel Launches East® version 6.3 for Adaptive Dose-Escalation Studies and Accurate Interim Trial Prediction

Game-changing new features in dose-escalation designs, gatekeeping procedures for multiple endpoints, and trial prediction tools, continue East® software’s twenty year tradition of reliable innovation.

Cambridge, MA, July 15, 2014 – Cytel Inc., the industry’s leading provider of adaptive trial design software, consultancy and services, announced today the release of East® version 6.3.

East® 6.3 addresses both emerging and persisting challenges in design including accurate prediction of the future course of a study based on accumulating data, advanced tools for multiplicity adjustment (including parallel and serial gatekeeping procedures), and modern dose-escalation methods to accurately estimate a therapeutic’s maximum tolerated dose (MTD).

“As East® marks two decades of helping medical drug and device developers design and implement adaptive clinical trials, we continue to listen to our users’ needs and deliver powerful, valuable tools to serve sponsors in planning and optimizing their clinical development options. We greatly appreciate our user community’s extended support in helping us provide validated statistical software like East® and StatXact® that meet the needs of industry, academic, and regulatory organizations, including the U.S. Food and Drug Administration, the European Medicines Agency, and Japan’s Pharmaceuticals and Medical Devices Agency,” said Yannis Jemiai, Vice President of Software and Consulting at Cytel Inc.

This latest release of East® introduces several new modules, including:

East® ESCALATE offers design, simulation and monitoring capabilities for some of the latest model-based dose-escalation designs. These include popular Bayesian methods such as the modified Toxicity Probability Intervals, first advocated by prominent M.D. Anderson Cancer Center statisticians, and the Bayesian , developed and widely used at Novartis Oncology. East® ESCALATE aims to make these advanced mathematical tools available to every Phase 1 trial team.

East® PREDICT introduces cutting-edge tools for simulating and forecasting the future course of a trial based on current data. As the cost, complexity and duration of clinical development increases, sponsors face many difficult decisions related to the successful outcome of their trials. East® PREDICT applies predictive statistical models to interim data to forecast what the therapeutic effect will be once the study ends. East® PREDICT also allows the sponsor to quantify the uncertainty associated with study duration and other important milestones, such as hitting target enrolment numbers or the timing of interim analyses, while accounting for variation in individual study site performance.

East® MULTI-ARM and East® ENDPOINTS address the increasingly important issue of selecting the right multiple testing strategy in studies with multiple competing objectives. When designing a confirmatory clinical trial, selecting the optimal multiple comparison procedure and hypothesis testing sequence plays the critical dual role of ensuring strong control of type-1 error to satisfy regulatory requirements, and improving the product label.

East® EXACT leverages Cytel’s expertise in exact non-parametric inference algorithms and computation to address small sample designs with binary endpoints and interim analyses.

East® PROCs provides the interim monitoring tools of East® in the convenient form of a SAS® procedure, which can be integrated into existing SAS code. East® designs can easily be converted to SAS format for interim analysis, so that users can take full advantage of the powerful data management and reporting capabilities in SAS®.

East® 6.3 is available immediately. Use the contact info below to request evaluations and upgrades.

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For East 6.3 product, sales or upgrade queries: [email protected]

For further info and inteview requests: Michael Weitz Director of Marketing Cytel, Inc. +1 617 528 7132 [email protected]

About Cytel At Cytel, we’re helping to shape the future of drug development. Specializing in adaptive trials, our cutting-edge trial design, implementation and operations software is enabling companies of all sizes to increase clinical success rates.

East® is our trial design software, developed to power your trials to success. First introduced in 1994, East® has been relied on to design countless clinical trials performed in industry, government, and academia. Regulatory authorities throughout the world use East®.

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