VinceC,
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Tuesday July 28, 8:02 am Eastern Time
Company Press Release
Cell Pathways Initiates Pediatric Safety Study With FGN-1 -- Exisulind
HORSHAM, Pa.--(BW HealthWire)--July 28, 1998--Cell Pathways Inc. today announced that it has initiated an open-label pediatric safety study of its lead investigational agent, FGN-1(TM) (exisulind).
The clinical study will evaluate the maximum tolerated dose and pharmacokinetics of FGN-1 in six children with adenomatous polyposis coli (APC) over a two-to-four month period of treatment. The trial is ongoing at Children's Hospital in Denver, Colo. under the direction of principal investigator, Edward Hoffenberg, M.D.
Based on the results from these first six patients, Cell Pathways plans to expand the study to include up to 20 children with APC at multiple sites throughout the United States.
''This trial represents a first step in expanding the potential usage of FGN-1 to an even greater percentage of the total APC patient population,'' said Rifat Pamukcu, M.D., co-founder, chief scientific officer, and senior vice president of research and development at Cell Pathways.
''Individuals with APC typically begin developing large numbers of precancerous colon polyps at a young age and must today often undergo colectomy (surgical removal of the colon) by their late teens or early adulthood in order to lower their risk of developing colon cancer. For this reason we have long wanted to evaluate the safety and ability of FGN-1 to reduce polyp formation in these young patients, as a potential alternative to surgical intervention. We had these children particularly in mind when we founded Cell Pathways almost nine years ago.''
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 in an adult patient population, and is additionally conducting clinical trials of the drug in four other indications. These include the prevention of precancerous polyp formation in individuals who otherwise sporadically, but repeatedly form such polyps, the prevention of breast and prostate cancer recurrence, and the treatment of lung cancer.
On July 9, 1998, Cell Pathways announced that the FDA had designated FGN-1 a ''Fast Track'' product for the reduction in development of new polyps in patients with adenomatous polyposis coli (APC).
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) |
