Cell Pathways Advances Clinical Development of Second-Generation SAANDs Drug, CP461.Business Editors/Health & Medical Writers HORSHAM, Pa.--(BW HealthWire)--Aug. 3, 2000 Cell Pathways, Inc.(Nasdaq:CLPA CLPA CC-Link Partner Association CLPA Club Loisirs et Plein Air (Montpellier, France) CLPA Child Labour Programme of Action (national plan to eliminate child labour in South Africa) ) today announced that the Company has completed Phase IB human testing of its second-generation selective apoptotic antineoplastic drug (SAAND), CP461, which the Company is developing as a potential treatment for cancer. Results of this safety trial demonstrated that CP461 can be chronically administered orally at doses that achieve or exceed targeted blood levels and are well tolerated by cancer patients. "Based on these encouraging safety results, we are now actively planning Phase II studies of CP461 as a single agent in several different cancer indications," said Robert Bellet, M.D., senior vice president, clinical and regulatory affairs. "We plan to start enrollment to the first of these trials late in the fourth quarter of this year or early in the first quarter of 2001. Based on promising preclinical results with this drug in combination chemotherapy, we are also planning to initiate Phase I safety studies combining CP461 and other chemotherapeutic agents in the fourth quarter of this year." Cell Pathways, Inc., headquartered in Horsham, Pa., is a development stage pharmaceutical company focused on the research and development of novel and unique medications to prevent and treat cancer. The Company's lead product candidate, Aptosyn(TM) (exisulind), is currently under review by the U.S. Food and Drug Administration as a potential new therapy for the prevention and treatment of precancerous precancerous /pre·can·cer·ous/ (-kan´ser-us) pertaining to a pathologic process that tends to become malignant. pre·can·cer·ous adj. colon polyps in patients with familial adenomatous polyposis familial adenomatous polyposis Familial polyposis An AD condition affecting ±50,000–US, characterized by progressive development of hundreds of adenomatous colorectal polyps; progression to cancer Molecular pathology APC (FAP (language) FAP - The assembly language for Sperry-Rand 1103 and 1103A. [Listed in CACM 2(5):16 (May 1959)]. ). The Company is also conducting further studies with Aptosyn(TM), both as a single agent and in combination with conventional chemotherapeutics, for the treatment of a variety of cancerous and precancerous indications including the prevention of recurrent prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. . For additional information on Cell Pathways, Inc., visit the Company's website at http://www.cellpathways.com. Certain statements made herein, and oral statements made in respect hereof, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Such statements are those which express plan, anticipation, intent, contingency or future development and/or otherwise are not statements of historical fact. These statements are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Such risks and uncertainties relate to, among other factors, the absence of approved products; history of operating losses; early stage of development; the costs, delays and uncertainties inherent in basic pharmaceutical research, drug development, clinical trials and the regulatory approval process, with respect to both the Company's current product candidates and its future product candidates, if any; dependence on development of Aptosyn(TM) (exisulind); the limitations on, or absence of, the predictive value pre·dic·tive value n. The likelihood that a positive test result indicates disease or that a negative test result excludes disease. predictive value a measure used by clinicians to interpret diagnostic test results. of data obtained in laboratory tests, animal models and human clinical trials when planning additional steps in product development; the uncertainty of obtaining regulatory approval, including uncertainty of approval of the New Drug Application submitted for Aptosyn(TM) (exisulind) for familial adenomatous polyposis) a rare disease that puts those afflicted at high risk of developing colon cancer colon cancer, cancer of any part of the colon (often called the large intestine). Colon cancer is the second most common cancer diagnosed in the United States. ,) whether in connection with the adequacy of the data generated in the clinical trials of Aptosyn(TM) (exisulind) or otherwise; the uncertainty of the effect of product approval, if achieved, on the market price of the Common Stock; the timing and scope of any approval which might be received for any compound for any indication in the future; acceptance by providers of healthcare reimbursement; the validity, scope and enforceability of patents; the actions of competitors; dependence upon third parties; product liability; and the need for further financing. These and other risks are detailed in the Company's reports filed from time to time under the Securities Act of 1933 and/or the Securities Exchange Act of 1934, including the sections entitled "Business," "Risk Factors," "Management's Discussion and Analysis Management's discussion and analysis (MD&A) A report from management to shareholders that accompanies the firm's financial statements in the annual report. It explains the period's financial results and enables management to discuss topics that may not be apparent in the financial of Financial Condition and Results of Operations" and "Other Events" in the Company's reports on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 1999, Form 10-Q Form 10-Q See 10-Q. for each of the first three quarters of 2000, Form 8-K Form 8-K The form required by the SEC when a publicly held company incurs any event that might affect its financial situation or the share value of its stock. Form 8-K See 8-K. for the month of August 1999, and Form S-3 filed in December 1999. You are encouraged to read these filings as they are made from time to time. They are available over the Internet from the SEC in its EDGAR Edgar or Eadgar (both: ĕd`gər), 943?–975, king of the English (959–75), son of Edmund, king of Wessex. In 957 the Mercians and Northumbrians rebelled against Edgar's brother Edwy and chose Edgar as their king. database. Given the uncertainties affecting pharmaceutical companies in the development stage, current and prospective investors are cautioned not to place undue reliance on any such forward-looking statements, any of which may turn out to be wrong due to inaccurate assumptions, unknown risks, uncertainties or other factors. The Company undertakes no obligation to update or revise the statements made herein or the factors which may relate thereto. |
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