Cell Pathways' Aptosyn -- Exisulind -- Inhibits The Rise In PSA Levels in
Prostate Cancer Patients Following Radical Prostatectomy
Business Editors/Health & Medical Writers
HORSHAM, Pa.--(BW HealthWire)--Nov. 16, 1999--Cell Pathways,
Inc. (Nasdaq:CLPA) today announced positive results from an analysis
of the completed clinical trial of its lead drug Aptosyn(TM)
(exisulind) in prostate cancer patients.
Before entry into the study, each of these men had exhibited
rising prostate specific antigen (PSA) levels, despite having had his
prostate surgically removed. In such a patient, a rise in PSA suggests
a recurrence of the cancer and an increased risk of developing
advanced disease.
After one year, the patients receiving Aptosyn experienced a
statistically significant inhibition of the rise in average PSA levels
compared to those on placebo.
"We are very excited about these findings," said Rifat Pamukcu,
M.D., chief scientific officer of the company. "They indicate that at
the end of one year of therapy, Aptosyn significantly slowed the rise
of PSA levels in men at risk of recurrent prostate cancer. These
results confirm the earlier positive six-month interim analysis of
these patients. There is much to be learned from this study, and we
are now engaged in more in-depth analyses of the data."
He continued, "To our knowledge, the Food and Drug Administration
(FDA) has yet to approve a treatment for prostate cancer solely on the
basis of a drug effect on PSA levels. The medical community,
nonetheless, widely regards PSA as a surrogate marker indicative of
the status of the disease, particularly in a patient who has had his
prostate surgically removed.
"We plan to discuss with the FDA the overall clinical development
plan with the ultimate goal of obtaining approval for Aptosyn for the
prevention and treatment of prostate cancer."
Ninety-two of 96 enrolled patients were evaluable in this
randomized double blind, placebo-controlled, multi-center trial. Of
the 92 evaluable patients, 47 received placebo and 45 received
Aptosyn. Results from the 92 evaluable patients showed that the rise
in average PSA levels in the Aptosyn-treated group was significantly
lower than that seen in the placebo-treated group.
The company also performed a subgroup analysis in which patients
were prospectively classified as high-, intermediate- and low-risk for
developing metastatic disease.
The one-year treatment data showed statistically significant
differences in the rise in average PSA levels between Aptosyn and
placebo patients in the high-risk group, and a strong trend toward
significance in the intermediate risk group. The safety profile of
Aptosyn was similar to those observed in previous clinical trials,
with two patients discontinuing therapy due to indigestion.
"The fact that we obtained statistically significant results even
in this high-risk subgroup of patients is especially compelling.
Current management is that many of these men will eventually be
treated by chemical castration if their PSA continues to rise. These
findings will be submitted for presentation at scientific meetings and
to peer-reviewed journals over the coming months.
"Given that we are confident in our belief that Aptosyn is having
activity in prostate cancer, we are now conducting four open-label
studies of Aptosyn across several stages of prostate cancer, and
expect to have results of those studies during the coming year," said
Dr. Pamukcu.
On-Going Clinical Research
Aptosyn is Cell Pathways' lead drug candidate from a new class of
compounds called selective apoptotic anti-neoplastic drugs (SAANDs).
These compounds inhibit a cyclic GMP phosphodiesterase and selectively
induce apoptosis (programmed cell death) in abnormally growing
precancerous and cancerous cells but not in normal cells.
Because SAANDs do not affect 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.
A New Drug Application for the use of Aptosyn for the prevention
and treatment of precancerous colonic polyps in patients with Familial
Polyposis (FAP), which was submitted on August 25, 1999, is currently
under review by the FDA. A one-year trial of Aptosyn in children with
FAP is nearing full enrollment.
Additional clinical trials with Aptosyn are underway that target
breast and lung cancers, Barrett's Esophagus and sporadic colonic
polyps. Cell Pathways recently announced a collaboration with Rhone
Poulenc Rorer to study the combination of Aptosyn and Taxotere(R) in
prostate, lung, breast and pancreatic cancers.
CP-461, Cell Pathways' second generation SAAND, is a compound
with higher apoptotic potency and is targeted for cancer indications.
CP-461 recently achieved high blood levels and good tolerability in a
Phase Ia trial and is currently in a Phase Ib trial in cancer
patients.
Cell Pathways, headquartered in Horsham, Pa., 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.
Note: 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 that 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
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 NDA submitted for exisulind for APC, whether in
connection with the adequacy of the data generated in the clinical
trials of Aptosyn(TM) (exisulind) or otherwise; 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, 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.
--30--rl/sf* dc/sf
CONTACT: Cell Pathways, Inc.
Rifat Pamukcu, 215/706-3800
or
J. Kureczka Associates
Joan Kureczka, 415/821-2413
KEYWORD: PENNSYLVANIA
INDUSTRY KEYWORD: BIOTECHNOLOGY MEDICAL PHARMACEUTICAL PRODUCT
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