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 cellgate.
Cellgate Inc.
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