Preclinical Studies Show Cell Pathways' Exisulind is Synergistic With Conventional Chemopreventive and Chemotherapeutic Drugs.
Cell Pathways, Inc. (Nasdaq:CLPA) today announced results demonstrating synergy between the company's lead investigational drug, exisulind, and chemopreventive and chemotherapeutic drugs in both cell culture and animal models of lung cancer.
The new findings were presented today by Cell Pathways' scientists and their collaborators from the University of Colorado at the annual meeting of the American Society of Clinical Oncology (ASCO) in Atlanta.
Cell Pathways also noted the publication of a study in the ASCO meeting proceedings demonstrating the ability of exisulind, and several other selective apoptotic anti-neoplastic drugs (SAANDs), including CP461, to induce apoptosis in leukemia and myeloma cell lines.
Company researchers and their collaborators at Columbia University additionally published in the meeting proceedings results from a preclinical study that further shows the ability of exisulind and an additional Cell Pathway's SAAND, CP248, to trigger apoptosis in both androgen-sensitive and androgen-insensitive prostate cancer cells.
Synergistic Effects of Exisulind With Other Agents
According to the research presented today, exisulind demonstrated synergistic activity with chemopreventive and conventional therapeutic agents against lung cancer in both cell culture models and mice bearing human tumors. Exisulind alone inhibited by 50 percent the growth of small cell and non-small cell lung cancer cell lines at concentrations of 150-225 micromolar.
When exisulind was combined with potential chemopreventive agents such as cis-retinoic acid or nordihydrogualarctic acid (NDGA) or chemotherapeutic agents such as cisplatin or paclitaxel (taxol), the researchers observed strong synergistic activity between exisulind and the other agents at concentrations that were subtherapeutic for each drug alone.
The researchers also showed that dietary exisulind alone, at doses of up to 1250 ppm of diet, reduced tumor growth in mice bearing human lung cancers by 30%. When the mice received both dietary exisulind and injections of cisplatin (three times at 10-14 mg/kg body weight on the first week after tumor implantation), the combined treatment significantly increased the inhibitory effects on tumor growth to 60 - 85%. The cisplatin injections alone had no significant effect on tumor growth.
"Exisulind works by a novel mechanism of action that is separate and different from that of currently available chemotherapeutic and chemopreventive drugs," said Rifat Pamukcu, senior vice president of research and development at Cell Pathways. "The synergy between exisulind and those therapeutics demonstrated in these studies suggests that exisulind may be a potentially useful addition to the chemotherapeutic arsenal currently used to treat cancers."
Exisulind and other SAANDs represent a novel class of potential therapeutic agents that target a novel form of cyclic GMP phosphodiesterase (cGMP-PDE). Cell Pathways' scientists believe that this enzyme, whose production appears to be selectively increased in precancerous and cancerous cells, interferes with the abnormal cells' ability to process the message telling them to die by apoptosis.
By specifically inhibiting the action of the novel cGMP-PDE, exisulind and other SAANDs enable abnormal cells to process an apoptotic signal and commit suicide without affecting normal cells. Cell Pathways is currently conducting human clinical studies of exisulind in a variety of indications for the prevention or treatment of cancer, and recently began human safety studies with a second SAAND, CP461.
Cell Pathways, Inc., headquartered in Horsham, is a development stage pharmaceutical company focused on the research, development and commercialization of products to prevent and treat cancer.
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 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 and clinical trials, with respect to both the company's current product candidates and its future product candidates, if any; dependence on development of exisulind; the limitations on, or absence of, the predictive value 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, and the timing and scope of any approval received; acceptance by providers of healthcare reimbursement; the validity, scope and enforceability of patents; the actions of competitors; dependence upon third parties; product liability; the need for further financing; and other risks detailed in Cell Pathways, Inc. 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" and "Risk Factors" in the company's report on Form 10-K for the year ended December 31, 1998. Given these uncertainties, current and prospective investors are cautioned not to place undue reliance on any such forward-looking statements. The company undertakes no obligation to update or revise the statements made herein or the factors which may relate thereto.
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|Date:||May 18, 1999|
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