ALL,
Some interesting news today from CPI:
Company Press Release
Cell Pathways Completes Enrollment in Pivotal Trial Investigating the Ability of Prevatac -- Exisulind -- to Prevent Prostate Cancer Recurrence
HORSHAM, Penn.--(BW HealthWire)--Oct. 7, 1998--Cell Pathways, Inc. today announced that the company has completed patient enrollment in its pivotal Phase II/III clinical study of the ability of Prevatac(tm) (exisulind), formerly known as FGN-1(tm), its lead product candidate, to prevent recurrence of prostate cancer.
The double-blinded, placebo-controlled trial is being conducted at five centers across the United States and is a one-year study. The trial enrolled 90 patients whose prostate specific antigen (PSA) levels were rising following radical prostatectomy, indicating an increased risk of metastatic disease.
''If Prevatac(tm) can prevent a rise in PSA levels in patients at a point at which they have only subclinical disease, we believe that this change may indicate that Prevatac is slowing or halting the spread of their prostate cancer, thus delaying or eliminating the need for hormonal treatments,'' said Rifat Pamukcu, M.D., chief scientific officer, and senior vice president of research and development at Cell Pathways.
''This would potentially allow these men to retain their post-surgical sexual function and lead relatively normal lives while controlling their disease.''
Cell Pathways expects to report interim trial results covering the first six months of patient observations during the first half of 1999.
The American Cancer Society (ACS) estimates that 184,500 new cases of prostate cancer will be diagnosed in the United States during 1998. This cancer is the second leading cause of cancer deaths in men, accounting for an estimated 39,200 deaths this year. The incidence of prostate cancer increases with age, with more than 75 percent of all prostate cancers diagnosed in men over age 65.
Screening for prostate cancer involves the monitoring of patient's blood for rising levels of prostate-specific antigen (PSA) and by rectal examination. The ACS recommends that such tests be offered annually, beginning at age 50, to men who have a life expectancy of at least 10 years and to younger men who are at high risk, such as those with a strong familial predisposition.
Fifty-eight percent of all prostate cancers are discovered while still localized; such patients are often treated with surgery or radiation. Hormones and chemotherapy or combinations of these may be employed for the treatment of recurrent or metastatic disease. According to the ACS, 67 percent of men diagnosed with prostate cancer survive 10 years and 50 percent survive 15 years.
Prevatac(tm) (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. In addition to the prostate cancer study, Cell Pathways will complete in January 1999 a pivotal Phase III trial for the prevention of polyp formation in adults with adenomatous polyposis coli (APC) and is conducting clinical trials of the drug in four other indications.
These include a pediatric APC study; the regression of precancerous polyps in individuals who otherwise sporadically, but repeatedly form such polyps; the prevention of breast cancer recurrence; and the treatment of lung cancer. On July 9, 1998, Cell Pathways announced that the FDA had designated Prevatac a ''Fast Track'' product for the reduction in development of new polyps in patients with APC.
Cell Pathways, Inc. is a pharmaceutical company focused on the development and commercialization of products to prevent and treat cancer. Assuming stockholder approval on November 2 and 3, 1998 of the previously announced combination with Tseng Labs, Inc. (Nasdaq:TSNG - news), shares of Cell Pathways would commence trading on the Nasdaq National Market System under the symbol CLPA.
For additional information on Cell Pathways, Inc., visit the company's website at cellpathways.com.
Except for the historical information contained herein, this news release contains forward-looking statements relating to the Company's clinical trial program, the possible clinical effects of Prevatac(tm) exisulind, and the expected date for reporting interim clinical trial results of Prevatac(tm). Actual results could differ materially as a result of risk-related factors over which the Company has no control, including the time required for and results of clinical trials, and other factors including, without limitation those discussed in the Joint Proxy Statement of the Company and Tseng Labs, Inc. dated Sept. 21, 1998, under the captions ''Risk Factors-Risks Related to the Operations of CPI'' and ''CPI Business.''
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Contact:
Cell Pathways Inc.
Rifat Pamukcu, M.D., 215/706-3800
or
J. Kureczka Associates
Joan Kureczka/Jesse Fisher, 415/821-2413
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