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CELL PATHWAYS EXPECTS DELAY IN PREVATAC'S COMMERCIALIZATION.

Cell Pathways, Inc. (Nasdaq:CLPA), Horsham, Pa., anticipates a delay in the filing of its NDA for its novel investigational drug, PREVATAC(tm) (exisulind) for Adenomatous Polyposis Coli (APC), which was initially planned for March of this year. A preliminary evaluation of the unblinded data from the Phase III trial of exisulind for APC suggests that the study did not achieve a statistically significant clinical response when compared to placebo.

"This result comes as a surprise to all of us at Cell Pathways since it appears inconsistent with data from previous Phase I/II and extension studies in this patient population, as well as from studies in animal models and cell culture systems," said Rifat Pamukcu, M.D., chief scientific officer at Cell Pathways. "We are continuing to evaluate the data in an attempt to isolate the causes underlying such a result. This process is expected to continue for some weeks." As previously announced, clinical trials in other precancerous and cancerous conditions continue, and Cell Pathways expects to have interim data in a prostate cancer study in March or April.

"As a result of this preliminary evaluation, Cell Pathways does not expect to make its anticipated NDA filing for APC in March of this year," said Robert Towarnicki, chief executive officer and president at Cell Pathways. "Upon completion of the analysis of the data the company will establish a revised development and commercialization plan for the APC indication."

Cell Pathways is currently conducting pivotal trials of PREVATAC (exisulind) for preventing the recurrence of prostate and breast cancer and for the treatment of sporadic precancerous colon polyps, as well as a pilot study in lung cancer and a Phase II study in Barrett's Esophagus.

Exisulind and other of Cell Pathways compounds, which inhibit a cyclic GMP phosphodiesterase and cell growth, and induce apoptosis (programmed cell death), but do not inhibit COX pathways, are potentially useful for the treatment of precancerous and cancerous lesions. Cell Pathways has identified over 500 additional compounds, in multiple chemical classes, many of which have significantly greater apoptotic activity than PREVATAC (exisulind). The selectivity of these compounds for neoplastic cells is expected to yield agents to treat precancerous and cancerous cells without the toxicities associated with conventional chemotherapeutic agents. The company has an IND for human clinical testing of one additional higher potency compound, CP461, which is targeted for use in cancer indications.

Cell Pathways, Inc. is a pharmaceutical company focused on the development and commercialization of products to prevent and treat cancer. For additional information on Cell Pathways, Inc., visit the company's website at http://www.cellpathways.com.

For more information, call 215/706-3800.
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Comment:CELL PATHWAYS EXPECTS DELAY IN PREVATAC'S COMMERCIALIZATION.
Publication:Biotech Business
Geographic Code:1USA
Date:Mar 1, 1999
Words:438
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