Cell Pathways Highlights Product Pipeline At Annual Meeting of Shareholders.Business Editors & Health/Medical Writers BIOWIRE2K HORSHAM, Pa.--(BW HealthWire)--May 29, 2002 At its Annual Meeting of Shareholders today, 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) ) is providing an update on its product pipeline and reviewing its business goals for 2002. "In 2001, we saw solid progress in our efforts to become a leading developer and marketer of products to treat and prevent cancer, particularly in the areas of clinical development and the validation of our novel molecular targets," said Robert J. Towarnicki, chairman and chief executive officer of Cell Pathways. "During 2002, we are continuing this strong clinical focus. By year-end, we expect to complete enrollment in our Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trial with Aptosyn(R) and Taxotere(R) in the treatment of advanced non-small cell lung cancer Lung Cancer, Non-Small Cell Definition Non-small cell lung cancer (NSCLC) is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description There are two kinds of lung cancers, primary and secondary. (NSCLC NSCLC non (or cancer). NSCLC Non-small cell lung cancer, see there ). We are also developing a registration strategy aimed at supporting approval for CP461 in one or more cancer indications. In addition, we plan to initiate clinical testing of CP461 in Crohn's disease Crohn's disease: see colitis. and ulcerative colitis ulcerative colitis Inflammation of the colon, especially of its mucous membranes. The inflamed membranes develop patches of tiny ulcers, and the diarrhea contains blood and mucus. , expanding our focus with that drug beyond cancer to autoimmune autoimmune /au·to·im·mune/ (-i-mun´) directed against the body's own tissue; see under disease and response. au·to·im·mune adj. and inflammatory diseases Noun 1. inflammatory disease - a disease characterized by inflammation disease - an impairment of health or a condition of abnormal functioning NEC, necrotizing enterocolitis - an acute inflammatory disease occurring in the intestines of premature infants; ." Mr. Towarnicki continues, "We are working to help support these development efforts through sales of Gelclair(TM) Concentrated Oral Gel to the oncology oncology /on·col·o·gy/ (ong-kol´ah-je) the sum of knowledge regarding tumors; the study of tumors. on·col·o·gy n. community. Market research suggests a potential market size of approximately $100 million. We received favorable fa·vor·a·ble adj. 1. Advantageous; helpful: favorable winds. 2. Encouraging; propitious: a favorable diagnosis. 3. responses from our exhibit discussions at the American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. and the Oncology Nursing n a medicine or substance used to treat cancer. compounds." Product Update Cell Pathways is providing an update on the current status of clinical development for Aptosyn(R) and CP461. -- Patient enrollment continues in the Phase III clinical study of Aptosyn(R) and Taxotere(R) in patients with NSCLC who have failed prior platinum therapy. Cell Pathways expects to achieve full enrollment by year-end. Patients will be followed for one year with a survival endpoint. -- Early results from a Phase IIa study of CP461 (400 mg daily) in eight evaluable patients with hormone refractory prostate cancer and measurable metastatic disease on CT scan included a near complete response in lymph node metastases in one patient, a strong partial response in the liver metastasis of another patient, and arrest of rapidly progressing liver metastases in a third patient. Encouraged by these results, Cell Pathways is expanding its Phase II investigations to optimize the dosing of CP461 prior to committing to registration trials in this indication. Investigators have received IRB approval to study CP461 at a dose of 800 mg daily and are currently enrolling patients. -- CP461 Phase IIa study in patients with chronic lymphocytic leukemia -- To date, five of the initial 15 previously untreated patients receiving 400 mg daily CP461 have continued to respond to therapy for periods ranging up to 11 months of treatment. In a later-starting group at an 800 mg daily dose, five of eight patients have continued to respond to therapy for periods ranging up to 22 weeks. Both groups continue on study. Encouraged by these results, Cell Pathways is expanding its Phase II investigations to optimize the dosing of CP461 in this indication prior to committing to registration trials in this indication. -- CP461 Phase IIa study in advanced kidney cancer -- Sixteen patients who previously had been heavily treated with chemotherapy were enrolled to receive 400 mg CP461 daily. As reported in January, six of the sixteen patients achieved stable disease. On the basis of these results, Cell Pathways has received IRB approval to investigate CP461 in 15 additional patients at an 800 mg dose, and is currently enrolling patients in that study. -- CP461 Phase IIa studies in patients with Crohn's disease and ulcerative colitis -- At the American Gastroenterology Association meeting on May 21, Cell Pathways reported positive results for CP461 in dogs with refractory inflammatory bowel disease, a condition that is normally treated with the same drug therapies as human ulcerative colitis and Crohn's disease. These results showed the ability of the drug to resolve signs and symptoms of the disease during therapy, and additionally demonstrated the presence of the molecular targets for CP461 in colon tissue from both a treated dog and from human patients with inflammatory bowel disease. Encouraged by these results, Cell Pathways plans to initiate Phase II human clinical trials with CP461 in inflammatory bowel disease in 2002. These trials represent the first expansion for Cell Pathways product platform beyond cancer, to autoimmune and inflammatory diseases. About Cell Pathways Cell Pathways, Inc., headquartered in Horsham, Pennsylvania Horsham is a census-designated place (CDP) in Montgomery County, Pennsylvania, United States. The population was 14,779 at the 2000 census. Horsham is located entirely within Horsham Township, Pennsylvania. , is a development stage pharmaceutical company focused on the research and development of novel and unique medications to treat and prevent cancer and to treat certain inflammatory diseases. The company additionally markets and sells oncology-related products made by others. The company's initial drug candidates in clinical development are Aptosyn(R) (exisulind) and CP461. For additional information on Cell Pathways, Inc., visit the Company's web site at http://www.cellpathways.com. Cell Pathways will hold a teleconference and simultaneous webcast to discuss this information on May 31, 2002 beginning at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time). The webcast will be accessible through the company web site at www.cellpathways.com. A replay of the teleconference will be made available for one week and will be accessible immediately following the end of the call.
The dial-in information is as follows:
U.S. and Canada please dial: 888/532-3213
Outside of the U.S. please dial: 904/779-4754
Reference call identification number: 12486771
The replay information is as follows:
U.S. and Canada please dial: 800/252-6030
Outside of the U.S. please dial: 402/220-2491
Reference call identification number: 12486771
Editors Note: Aptosyn(R) is a registered trademark of Cell Pathways, Inc., Taxotere(R) is a registered trademark of Aventis Pharmaceuticals, Inc. and Gelclair(TM) is a trademark of Sinclair Pharmaceuticals Ltd. Certain statements herein, and oral statements made in respect hereof, constitute "forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. " 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: early stage of development; the costs, delays and uncertainties inherent in scientific research, basic pharmaceutical research, drug development, clinical trials and the regulatory approval process, with respect to both our current product candidates and our future product candidates, if any; the risk that accrual accrual, n continually recurring short-term liabilities. Examples are accrued wages, taxes, and interest. of our Phase III trial of Aptosyn(R) and Taxotere(R) is not completed by year-end; 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; uncertainty that additional studies, if any, may not be positive; uncertainty of obtaining regulatory approval of any compound for any disease indication whether due to adequacy of the development program, changing regulatory requirements Regulatory requirements are part of the process of drug discovery and drug development. Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country. or otherwise; the risk that the Company does not conduct the clinical studies it may have planned to conduct or does not pursue development plans it may have planned to pursue, including the risk that clinical testing of CP461 in Crohn's disease and ulcerative colitis are not initiated in 2002; the risk that a registration strategy for CP461 in cancer is not fully developed by year-end, whether due to the nature or timing of further clinical results or otherwise; the risk that clinical studies do not result in the safety and efficacy necessary to obtain regulatory approvals; the risks of conducting clinical trials, including the risk of conducting clinical trials of our drugs in combination with other drug therapies; the commercial risk and risk of liability in marketing and selling Gelclair(TM) Concentrated Oral Gel, including the risk that the prescribers do not prescribe the product and sales do not materialize, the risk that the Company does not achieve an arrangement for distribution of Gelclair(TM) into the dental market; the risk that the market opportunity available to Gelclair(TM) is smaller than estimated, due to inaccurate assumptions, competition or other factors; the risks associated with the product launch, manufacturing and marketing risks, and the risk that the Company's sales of Gelclair(TM) are less than the Company's minimum purchase obligations; the risks of providing marketing services promoting Nilandron(R) (nilutamide) manufactured by Aventis Pharmaceuticals, Inc.; the risk that the Company may enter into, or may fail to enter into, licensing, partnership or collaborative arrangements or strategic alliances which accord to other companies rights with respect to one or more Company compounds, technologies or programs or in which the Company acquires rights and obligations; the absence of approved products; history of operating losses operating loss The excess of operating expenses over revenue. As with operating income, operating losses exclude revenues and expenses from operations that are not considered a regular part of the business. Also called deficit. Compare operating income. and the need for further financing; dependence on the development, regulatory approval and market acceptance of one or more of our product candidates for one or more significant disease indications; the volatility of the market price of our Common Stock; our ability to sell securities registered under the shelf registration statement; acceptance of any product candidates by physicians and providers of healthcare reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. ; the actions of competitors; the pace of technological changes in the biopharmaceutical industry; dependence upon third parties; the validity, scope and enforceability of patents; the risk of pending or future class action securities litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. ; potential product liability claims; and availability and adequacy of insurance. These and other risks are detailed in our reports filed from time to time under the Securities Act and/or the Securities Exchange Act, 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 our annual 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. , quarterly reports on Form 10-Q Form 10-Q See 10-Q. and periodic reports on 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. and in such registration statements on Form S-3 as we may file from time to time. You are encouraged to read these filings as they are made. 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 at http://www.sec.gov and from the Company. Given the uncertainties affecting pharmaceutical companies in the development stage, you 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. No forward-looking statement can be guaranteed; actual future results may vary materially. Both forward-looking statements and statements of historic fact must be understood in the context of the risks referred to above which characterize our development stage business. We undertake no obligation to update or revise the statements made herein or the risk factors that may relate thereto. |
|
||||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion