CellGate, Inc. Initiates Phase I Clinical Study In Age-Related Macular Degeneration

Published: Nov 08, 2006

REDWOOD CITY, Calif., Nov. 8 /PRNewswire/ -- Cellgate Inc., a company developing novel anti-proliferative drugs to combat disease, has dosed the first patient in a Phase I dose-escalation study of CGC-11047 in patients with age-related macular degeneration (AMD). CGC-11047 is a novel polyamine analog that targets the hyper-proliferating blood vessel growth, known as choroidal neovascularization (CNV), associated with AMD.

The open label Phase I trial is designed to determine the safety and tolerability of CGC-11047 in patients with age-related macular degeneration. A total of fifteen patients will be treated in cohorts of escalating doses. Patients will be treated subconjunctivally, avoiding the need to inject into the eye. Patients will be monitored for adverse events and for preliminary evidence of suppression and regression of choroidal neovascularization following administration of CGC-11047. Peter Campochiaro, M.D., Professor of Opthalmology at the Wilmer Eye Institute of the Johns Hopkins School of Medicine is the primary investigator of the study.

"This is the second indication for CGC-11047 to enter the clinic, and we believe CGC-11047's potent anti-proliferative properties, distinct mechanism of action and ease of administration will make it an excellent drug candidate for this disease setting," said Edward F. Schnipper, M.D., President and Chief Executive Officer of Cellgate. "The potential we've observed for CGC-11047 to impede the blood vessel growth underlying AMD and to improve vision distinguish it from that of existing treatments. In addition, CGC-11047 may be complementary to other recently approved AMD therapeutics and its less invasive subconjunctival route of administration will provide an appealing patient benefit."

About CGC-11047

CGC-11047 is a polyamine analog that targets hyper-proliferating cells to halt cell growth and induce apoptosis. Polyamines are cell components considered essential for cell proliferation and differentiation. Cellgate's compounds are believed to work by displacing polyamines from their natural binding sites and preventing cell replication. In preclinical models of AMD, CGC-11047 has demonstrated the ability to suppress the growth of vascular lesions under the retina, as well as to cause a regression of the neovascular swelling and leakage that result in a loss of central vision.

Cellgate is also developing the anti-proliferative compound CGC-11047 for the treatment of certain cancers using a different dose formulation. A Phase I clinical trial of CGC-11047 in individual combinations with a variety of standard chemotherapeutics is ongoing in advanced solid tumor malignancies or lymphomas and a Phase II clinical trial has recently been initiated among hormone-refractory prostate cancer patients.

About Age-related Macular Degeneration

Age-related macular degeneration (AMD) is a chronic, progressive condition and is the leading cause of vision loss in adults over 55 in the U.S. AMD is characterized by the gradual loss of sharp, central vision and the ability to see fine detail. AMD can occur in two forms: dry and wet, with approximately ten percent of dry AMD progressing to the more severe or advanced form of wet, or neovascularizing, macular degeneration. In wet AMD, new blood vessels form below the central portion of the retina, known as the macula. Swelling and leakage from these new blood vessels damages the macula, resulting in the development of blind spots, distorted vision, and even severe central vision loss. Neovascular AMD is estimated to affect more than 1.7 million people in the U.S. alone and this number is increasing as the population ages. There is currently no cure for macular degeneration, though laser surgery, photodynamic therapy and emerging drug treatments have been shown to help slow disease progression.

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 and age-related macular degeneration, 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 polyamine analog compounds, CGC-11047 and CGC-11093, currently in Phase II and Phase I clinical trials with leading investigators. In addition, Cellgate has established a portfolio of promising anti-proliferative leads undergoing preclinical evaluation. For more information about Cellgate, please visit www.cellgate.com.

Cellgate Inc.

CONTACT: Edward F. Schnipper, M.D., President and Chief Executive Officerof Cellgate Inc. +1-650-610-7800, or schnipper@cellgate.com; or Karen L.Bergman, +1-650-575-1509, or kbergman@bccpartners.com, or Michelle Corral,+1-415-794-8662, or mcorral@bccpartners.com, both of BCC Partners forCellgate Inc.

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