REDWOOD CITY, Calif., Nov. 1 /PRNewswire/ -- 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.
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 www.cellgate.com.
CONTACT: Edward F. Schnipper, M.D., President and Chief Executive Officer,+1-650-610-7800, or firstname.lastname@example.org; or Karen Bergman,email@example.com, or Michelle Corral, firstname.lastname@example.org, bothof BCC Partners, +1-650-575-1509 or +1-415-794-8662, for Cellgate