http://my.webmd.com/news/3272
full article
SUGEN Initiates Phase II Trial in
Ovarian Cancer with SU101
Redwood City, CA, July 14, 1998 -- SUGEN today
announced the initiation of a Phase II trial with
SU101 in ovarian cancer, complementing existing
SU101 trials in brain (Phase III and Phase II) and
prostate cancer (Phase II). Ovarian cancer affects an
estimated 63,000 women and is the fifth most
common cancer among women in the United States.
The multicenter Phase II trial will enroll 30 patients
with recurrent ovarian cancer who have failed
standard therapy. Initial recruitment will take place
at the Mount Sinai Comprehensive Cancer Center in
Miami Beach and New York University Medical
Center, with at least two additional sites to be
initiated shortly. The study's primary objective is to
assess the efficacy of SU101 based on objective
response and stabilization of disease. Secondary
objectives include assessment of time-to-disease
progression, effect on CA 125 levels (an ovarian
cancer tumor marker) and safety.
Separately, SUGEN disclosed that it has closed
recruitment in the Phase II study of SU101 in
prostate cancer. The trial has enrolled 45 patients
with hormone refractory prostate cancer from five
participating trial sites. Preliminary results from this
study are expected to become available later this
year.
SU101 is a small molecule inhibitor that blocks the
signaling of the platelet-derived growth factor
(PDGF) receptor. The PDGF receptor is believed to
be the driving oncogene in subsets of brain, prostate,
ovarian and non-small cell lung tumors. In addition
to these trials, SU101 is being studied in a Phase III
trial for first-relapse glioblastoma, an aggressive
brain tumor, and in a Phase II combination trial of
SU101 and BCNU for newly diagnosed
glioblastoma patients. For further trial information,
please visit SUGEN's web site at www.sugen.com.
SUGEN, Inc. is a biopharmaceutical company
focused on the discovery and development of small
molecule drugs which target specific cellular signal
transduction pathways. These signaling pathways
are regulated by cell surface receptors or
intracellular signaling molecules known as tyrosine
kinases (TKs), serine-threonine kinases (STKs) and
tyrosine phosphatases (TPs). TKs, STKs and TPs
are three of the largest known families of enzymes in
the body and are key regulators of critical cellular
functions. Aberrant signaling of TKs, STKs and TPs
has been shown to result in a variety of chronic and
acute pathological diseases, including cancer and
diabetes as well as dermatologic, ophthalmic,
neurologic and immune disorders. In addition to
SU101, SUGEN currently has two other products in
clinical trials: SU5416 (a Flk-1/KDR angiogenesis
inhibitor) in multiple Phase I trials for the treatment
of solid tumor cancers and Phase I/II for Kaposi's
sarcoma; and SU5271 (an EGF receptor inhibitor) in
Phase I for the treatment of psoriasis. The Company
has research and development collaborations with
Zeneca, ASTA Medica and Allergan.
This press release contains, in addition to historical
information, forward-looking statements that involve
risks and uncertainties. The Company's actual
results, including the further development of SU101,
could differ significantly from the results discussed
in the forward-looking statements. Factors that could
cause or contribute to such differences include the
factors more fully discussed in the Company's 1997
Form 10-K, and most recent Form 10-Q and Form
S-3. The Company undertakes no obligation to
release the results of any revision to these
forward-looking statements which may be made to
reflect events or circumstances occurring after the
date hereof or to reflect the occurrence of
unanticipated events.
Additional written materials and press releases
regarding SUGEN are available through the SUGEN
Fax-On-Demand Information Service by dialing
1-888-329-4699.
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