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Business Wire PRECLINICAL RESEARCH DEMONSTRATES BROAD ANTICANCER ACTIVITY OF CELL PATHWAYS' SAANDS COMPOUNDS BUSINESS EDITORS/HEALTH & MEDICAL WRITERS
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ATLANTA, Ga.--(BW HealthWire)--May 1, 2000--New preclinical
research presented today at the 95th annual meeting of the American
Urological Association (AUA) further demonstrates the potential of
Cell Pathways, Inc.'s (Nasdaq:CLPA.O) selective apoptotic
antineoplastic drugs (SAANDs) for preventing and treating a variety of
cancers.
In a separate release, the company also announced the presentation
at AUA by principal investigators of detailed results from its Phase
II/III clinical study of Aptosyn(TM) (exisulind), Cell Pathways' lead
SAAND in the prostate cancer setting.
In one of the two preclinical studies, researchers at the
University of Alabama at Birmingham in collaboration with researchers
at Cell Pathways demonstrated the ability of Aptosyn(TM), the
company's lead investigational drug, to inhibit carcinogen-induced
bladder cancer in a rat model of urinary bladder tumorigenesis. Study
results showed that Aptosyn(TM) prevented the formation of bladder
tumors in drug-fed rats in a dose-dependant fashion, by up to 61%
compared to controls. The investigators observed no adverse effects on
weight gain or other signs of toxicity in the Aptosyn(TM)-fed animals.
"In human metabolic studies, approximately 56-78% of an oral dose
of Aptosyn(TM) is excreted unchanged in the urine," said Rifat
Pamukcu, M.D., chief scientific officer and senior vice president of
research and development at Cell Pathways. "This suggests that high
concentrations of the drug may be achieved locally in the urinary
tract. Taken with these new preclinical findings, we believe this drug
may have utility for the prevention or treatment of bladder cancer."
In a second study, the company researchers demonstrated the
ability of CP461, a second SAAND compound, to significantly inhibit
the rate of tumor growth in nude mice implanted with PC3 prostate
cancer cells. PC3 cells are resistant to both androgen hormones and
conventional chemotherapeutic drugs commonly used to treat patients
with prostate cancer. The researchers observed that control tumors in
untreated mice grew with a doubling time of 4.2 days, whereas tumors
in the animals treated with CP461 grew with a doubling time of
approximately 8.5 days. Throughout the study, the treated animals
tolerated CP461 well, no deaths occurred and body weights were
consistent with normal nude mice of the same age and sex. The
researchers also demonstrated that CP461 induced apoptosis in PC3
cells, but had no effect on apoptosis rates in normal prostate (PrEC)
cells.
"CP461 and other SAANDs slow prostate cancer growth by targeting
an apoptotic mechanism that is different from anti-cancer mechanisms
targeted by conventional chemotherapeutic drugs or hormonal
treatments," said Dr. Pamukcu. "Results of this study suggest that
CP461 may have utility as a treatment for men with prostate cancer,
whether or not their tumors have become resistant to hormonal
therapies."
Cell Pathways researchers and their collaborators have previously
demonstrated the ability of Aptosyn(TM) to inhibit tumorigenesis in
rodent models of chemically induced colon, mammary, and lung cancer,
as well as to inhibit the growth of malignant prostate and lung tumor
cells in mouse xenograft models. Aptosyn(TM) is currently undergoing
advanced clinical trials for the treatment and prevention of a variety
of cancer types, both on its own and in combination with currently
marketed chemotherapeutic agents. Aptosyn is also currently under
review by the Food and Drug Administration as a potential treatment
for precancerous colon polyps in individuals with familial adenomatous
polyposis (FAP).
CP461 works through the same mechanism of action as Aptosyn(TM),
but has been shown in laboratory studies to be 100-1000 times more
potent. Cell Pathways is currently completing Phase Ib human clinical
safety studies with CP461 in cancer patients.
Cell Pathways research has shown that its SAANDs compounds inhibit
a novel pattern of over-expressed cyclic GMP phosphodiesterases in
cancerous and precancerous cells. Inhibition of cGMP-PDE results in an
increase in cGMP which activates PKG, a downstream regulator of
apoptosis (programmed cell death). This activation allows the
apoptotic pathway to proceed and selectively induce apoptosis in
abnormally growing precancerous and cancerous cells. Because SAANDs do
not induce apoptosis in normal cells, they do not produce the serious
side effects normally associated with traditional chemotherapeutic
agents. They also do not inhibit cyclooxygenase (COX I or COX II) and
have not exhibited the gastric and renal toxicities reported to be
associated with non-steroidal anti-inflammatory drugs (NSAIDs),
including the COX II inhibitors.
Cell Pathways, Inc., headquartered in Horsham, Pennsylvania, is a
development stage pharmaceutical company focused on the research,
development and commercialization of novel and unique medications to
prevent and treat cancer. For additional information on Cell Pathways,
Inc., visit the Company's website at 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 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 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), 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 of Financial Condition and
Results of Operations" and "Other Events" in the Company's reports on
Form 10-K for the year ended December 31, 1999, Form 10-Q for each of
the first three quarters of 2000, Form 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 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.
--30--jb/sf*
CONTACT: Cell Pathways
Patrick T. Mooney, M.D., 215/706-3800 (Investors)
or
J. Kureczka Associates
Joan E. Kureczka, 415/821-2413 (Media)
KEYWORD: PENNSYLVANIA GEORGIA
INDUSTRY KEYWORD: MEDICAL MEDICAL DEVICES PHARMACEUTICAL PRODUCT
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