Cell Pathways Resumes Accrual in Phase III Study of Aptosyn and Taxotere; FDA Lifts Clinical Hold.

Business Editors/Health & Medical Writers

BIOWIRE2K

HORSHAM, Pa.--(BW HealthWire)--Dec. 7, 2001

Cell Pathways, Inc. (Nasdaq:CLPA) today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold to new patient accrual from the company's Phase III study of Aptosyn(TM) and Taxotere(R) in non-small cell lung cancer. The company is notifying the clinical sites that they can resume enrollment of new patients immediately.

In early October, the company suspended new patient accrual pending the independent Data and Safety Monitoring Board (DSMB) and FDA review of an interim safety analysis. In November, the DSMB recommended patient enrollment be allowed to resume. The FDA has now completed its review of the safety data, and has notified the company that new patient enrollment can resume. During the review period, the company continued to treat the approximately 200 patients that were enrolled in the study.

"We are pleased to be once again actively recruiting patients in this study," said Robert J. Towarnicki, president and chief executive officer of Cell Pathways, Inc. "We look forward to completion of this trial, which is focused on a patient population in great need of new therapies."

Cell Pathways, Inc., headquartered in Horsham, Pa., is a development stage pharmaceutical company focused on the research, development and commercialization of novel and unique medications to prevent and treat cancer. For additional information on Cell Pathways, Inc., visit the company's Web site at http://www.cellpathways.com.

Editors Note: Aptosyn(TM) is a trademark of Cell Pathways, Inc., and Taxotere(R) is a registered trademark of Aventis Pharmaceuticals Inc.

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