All,
Here is some GOOD NEWS:
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Thursday July 9, 8:05 am Eastern Time
Company Press Release
Cell Pathways' FGN-1 -- Exisulind -- Receives Fast Track Designation for Reducing New Polyp Formation in APC Patients
HORSHAM, Penn.--(BW HealthWire)--July 9, 1998--Cell Pathways Inc. today announced that the United States Food and Drug Administration (FDA) has designated FGN-1(TM) (exisulind), the company's lead investigational drug, a ''Fast Track'' product for the reduction in development of new polyps in patients with adenomatous polyposis coli (APC).
Under the FDA Modernization Act of 1997, designation as a Fast Track Product means that the FDA will facilitate the development and expedite the review of a drug if it is intended for the treatment of a serious or life-threatening condition, and it demonstrates the potential to address unmet medical needs for such a condition.
''We are very pleased that FDA has agreed to expedite its consideration of FGN-1 as a treatment for APC,'' said Rifat Pamukcu, M.D., chief scientific officer and senior vice president of research and development at Cell Pathways.
''This Fast Track designation underscores the potential of this drug to address an important unmet need for these patients.'' The company anticipates filing a New Drug Application (NDA) for FGN-1 in this indication during the first half of 1999.
FGN-1 (exisulind) is an orally active drug that acts through a novel mechanism to selectively induce apoptosis, or programmed cell death, in precancerous and cancerous cells without affecting normal cells. The company is currently completing a pivotal Phase III trial for the treatment of APC, and is additionally conducting clinical trials of the drug in four other indications.
Cell Pathways Inc. is a pharmaceutical company focused on the development and commercialization of products to prevent and treat cancer. On June 24, 1998 Cell Pathways announced a definitive agreement to combine with Tseng Labs Inc., (NASDAQ:TSNG - news).
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Contact:
Cell Pathways Inc.
Rifat Pamukcu M.D., 215/706-3800
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