Cytel Inc. Announces East(R) 4, EastSurv(TM) and EastAdapt(TM) Modules

CAMBRIDGE, Mass., Aug. 5 -- Cytel Inc., a leading provider of clinical trial design software and services, announced today the release of East(R) 4, EastSurv(TM) and EastAdapt(TM) modules, major new additions to the industry's most advanced system for designing, simulating and monitoring clinical trials. Through its powerful, yet easily understood new features, East 4 brings complex statistical and mathematical methodologies for designing and monitoring clinical trials to hundreds of current users in the biopharmaceutical industry, government, and academia.

With this release of the East 4 suite, investigators and sponsors can now conduct clinical trials with unprecedented flexibility. New design, monitoring, and simulation tools make it possible to identify promising new therapies earlier, drop ineffective or unsafe therapies earlier, and make data-dependent improvements, such as altering the sample size to avoid underpowered or inconclusive studies.

"East 4, EastSurv and EastAdapt are a major step forward in our mission to optimize clinical trials through advanced computational statistical methods," said Cyrus Mehta, Cytel's President and Co-Founder. "This release significantly expands the design and simulation capabilities of East through broad coverage of numerous one-, two- and K-sample designs, new graphical displays, new simulation tools to handle time-to-event trials in realistic settings, and new adaptive tools for added flexibility, all fully validated for regulatory purposes. The East 4 suite will enable sponsoring companies to increase the return on their investment in phase II, III and IV clinical trials, by reducing drug development costs and shortening time-to-market."

Key Features in East(R) 4

East 4 increases basic trial design types from eight to thirty-one. While earlier versions dealt primarily with two-sample studies, East 4's new designs address one-sample, two-sample, K-sample and regression problems.

Trial Design
- Design information-based trials allowing sample size adjustments at interim looks
- Design non-inferiority trials powered for superiority alternatives
- Calculate sample size and stopping boundaries for superiority, futility, non-inferiority and equivalence studies
- Choose symmetric, asymmetric, and futility stopping boundaries from the Wang-Tsiatis, Lan-DeMets, and Haybittle-Peto families; specify stopping boundaries from a number of published error-spending functions, or specify your own spending functions
- Examine design properties with interactive repeated confidence intervals
- Compare different trial designs side by side

Interim Monitoring
- Simultaneously track the test statistic, re-computed stopping boundaries, error spent, conditional power and post-hoc power through a convenient dashboard style user interface
- Calculate conditional power and repeated confidence intervals at each interim look
- Calculate adjusted p-values, confidence intervals and point estimates at the end of the study
- Use repeated confidence intervals for valid inferences when trials continue despite crossing a stopping boundary

Simulation
- Simulate trials to better understand how changing design parameters affect the trial's chance of success
- Use simulations before committing to a design to verify the properties of the study's test statistic, type I error and power

User Interface
- East 4 allows display of information in numerous tables and graphs and on a variety of scales to more easily understand trial data
- Fully integrated with Microsoft(R) Excel, East 4 preserves all useful Excel features, including formula computation, graphs, tables and data analysis reports
- Thoroughly linked with the MS Office 2000 environment, East 4 features Context Sensitive Help for fast and accurate self-learning

EastSurv(TM)

This brand new module allows investigators to design, simulate and monitor superiority and non-inferiority group sequential trials for time-to-event endpoints in which the patient enrollment is non-uniform, the hazard rates of the treatment arms change over time, and patients drop out at different rates on the two treatment arms. New simulation capabilities in EastSurv make it possible to design trials under general alternatives that do not require the assumption of proportional hazards.

EastAdapt(TM)

For the first time, users can conduct adaptive designs in a data-dependent manner, with the flexibility to change the sample size, spending function, number and spacing of interim looks, while preserving the type I error.

Availability and Platforms

The East 4 suite, including modules EastSurv and EastAdapt are available today for Windows NT/2000/XP. More information at http://www.cytel.com/, or call 617-661-2011 for a free demonstration.

About Cytel Inc.

Cytel Inc. has an 18-year track record as the premier provider of software and services for the design and analysis of clinical trials. Cytel provides software, training, and consulting to clinical trial sponsors seeking greater efficiency. Cytel's East(R) is used by every FDA division FDA and hundreds of biostatisticians and clinicians in industry and academia to design, simulate and monitor group sequential and adaptive flexible clinical trials. Over 10,000 customers also use Cytel's award-winning StatXact(R) and LogXact(R) software for exact statistical inference. Cytel Inc. is a privately owned company, with venture capital investment, headquartered in Cambridge, Massachusetts, and development operations in Pune, India.

CONTACT: Michael Weitz of Cytel Inc., +1-617-528-7132

Web site: http://www.cytel.com/

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