CYTEL DEBUTS EAST V3.0.

Cytel Software Corporation, a developer of specialized software for analyzing clinical data, has debuted East v3.0, software for the design, simulation and interim monitoring of flexible clinical trials. East is the most comprehensive and easy to use product of its kind, and will help sponsor companies increase the efficiency, accuracy and flexibility of their Phase II, III and IV clinical trials.

Group sequential and adaptive methods, which allow investigators to monitor clinical trials at interim time points while preserving the statistical integrity of the trial, are widely accepted by the FDA and industry. There is increasing interest in these innovative designs, which afford trial sponsors more flexibility and control over their clinical trials. However, implementing these methods requires a great deal of familiarity with sophisticated and computationally intensive statistical theory. East now makes it very easy to explore the characteristics of these designs and use them in Phase II and IV studies, in addition to Phase III studies where they have most frequently been employed.

Having software such as East will help study sponsors take advantage of the promise of flexible clinical trials. In the past ten years, the cost to develop a drug has more than doubled. Much of this cost is contained in an increasingly complex and lengthy clinical development period. Study sponsors must take every opportunity possible to identify and terminate ineffective and unsafe treatments, to fast-track winning treatments, and to avoid underpowered, inconclusive studies.

"The new East v3.0 has the power and flexibility to perform complicated calculations easily, quickly and accurately, and its simulation capability and visual display of information will help clinicians and statisticians communicate effectively and improve their decision making process," said Dr. Cyrus Mehta, founder and president, Cytel Software Corporation and adjunct professor of Biostatistics, Harvard University.

East makes it easy for biostatisticians and clinicians to:

-- Design, simulate and monitor superiority, futility, and non-inferiority studies for all endpoints

-- Retain complete control over the type-1 error and power of the trial

-- Re-adjust trial sample size and salvage underpowered studies

-- Easily try out multiple study designs, evaluate them through simulation, and choose the best one

-- Select from a wide variety of published spending functions that offer unprecedented flexibility over stopping probabilities

-- Run adaptive and information based simulations

-- Terminate futile studies early and identify and fast-track winning treatments sooner

About Cytel Software Corporation

Cytel is a world-recognized expert in exact statistics and group sequential methods for clinical trial design. More than 10,000 customers use Cytel's StatXact and LogXact software for exact statistical inference, and hundreds of clinicians and biostatisticians, including every division of the FDA, use East to design, simulate and monitor flexible clinical trials. Cytel Software is a privately owned company, headquartered in Cambridge, Massachusetts.

Cytel can be found on the World Wide Web at http://www.cytel.com.

For more information, call 617/528-7132.