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 II 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.
About Prostate Cancer
Prostate cancer is the second most common type of cancer found in
American men. The American Cancer Society estimates that there will be
about 234,460 new cases of prostate cancer in the United States in 2006.
Treatment for prostate cancer varies based on factors such as age, overall
health and the stage and grade of the cancer. Currently available
treatments include watchful waiting, surgery, radiation and hormone
therapy. Prostate cancer is the third leading cause of cancer death in men,
after lung cancer and colorectal cancer and approximately 27,350 men will
die of prostate cancer this year.
About Cellgate
Cellgate Inc. is a privately-held company advancing a portfolio of
anti- proliferative therapeutics with the potential to address a number of
diseases, including cancer, in which uncontrolled cell division is an
underlying cause. The company's lead products are advanced polyamine
analogs that act by selectively targeting proliferating cells and inducing
cell death to halt the progress of disease. Cellgate has two anti-cancer
polyamine analog compounds, CGC-11047 and CGC-11093, currently in Phase II
and Phase I clinical trials with leading investigators. Cellgate has also
established a portfolio of promising anti-proliferative leads, including a
novel compound with demonstrated preclinical activity in macular
degeneration. For more information about Cellgate, please visit
cellgate.
Cellgate Inc.
cellgate