Phase 2 Trial Initiated for Polyamine Analog as Treatment forMetastat

Phase 2 Trial Initiated for Polyamine Analog as Treatment for Metastatic
Hormone Refractory Prostate Cancer

REDWOOD CITY, Calif., Nov. 1

Cellgate Inc., a company developing novel anti-proliferative drugs to
combat cancers and other disease, today announced the initiation of a
Phase II clinical trial of its lead compound, CGC-11047. CGC-11047 is a
polyamine analog designed to halt cell growth and induce apoptosis.

The phase 2 clinical trial will enroll approximately 40 patients with
metastatic hormone refractory prostate cancer who have not yet received
prior chemotherapy. The primary endpoint for the study is efficacy based
on PSA (prostate specific antigen) response. Safety, tolerability and
time to progression will also be evaluated as part of the Phase II
study. CGC-11047 will be administered intravenously as a single-agent by
infusion once weekly for three weeks over a four-week cycle at a dose of
200mg.

"I am pleased to be participating in this innovative prostate cancer
study designed to evaluate CGC-11074 in patients who are actively
monitoring elevated PSA levels but have not yet progressed to treatment
with chemotherapy," said George Wilding, M.D., Director of the
University of Wisconsin Comprehensive Cancer Center. "This patient
population is a large one, consisting of men with limited alternatives
for managing their disease.

The potential to provide an effective means of controlling the
progression of their cancer without the toxicities associated with
traditional chemotherapies would represent an important improvement in
patient care."

"We are excited to be commencing Phase II clinical studies with our lead
compound, CGC-11047, a polyamine analog with anti-proliferative
properties," said Edward F. Schnipper, M.D., President and Chief
Executive Officer of Cellgate.

"CGC-11047 has been very well-tolerated in Phase I clinical trials and
has demonstrated promising activity in patients with advanced disease.
Based on these initial results and CGC-11047's mechanism, we feel this
is an ideal agent for this patient population."

Polyamines are cell components considered essential for cell
proliferation and differentiation. Cellgate has developed polyamine
analogs that target proliferating cells. Cellgate's compounds are
believed to work by displacing polyamines from their natural binding
sites and preventing cell replication. In two separate Phase I clinical
trials, a total of 20 patients (with a variety of advanced solid tumors)
have been treated with CGC-11047 to date. CGC-11047 has been well
tolerated with no dose-limiting toxicities reported. Preclinical in
vitro studies have shown that CGC-11047 is cytotoxic to several standard
tumor cell lines.

Source: Cellgate


knowledge is power - growing old is mandatory - growing wise is optional
"Many more men die with prostate cancer than of it. Growing old is
invariably fatal. Prostate cancer is only sometimes so."
http://community.webtv.net/PALMER_ENT/doc