Cellgate Inc., a company developing novel anti-proliferative drugs to combat cancer and other diseases, today announced the initiation of a Phase Ib clinical study of
CGC-11047 in patients with advanced solid tumor malignancies or lymphomas.
The Phase Ib study will evaluate the safety and pharmacokinetics of
escalating doses of CGC-11047, a polyamine analog drug candidate, in
individual combinations with four standard chemotherapeutics -- Gemzar(R)
(gemcitabine), Taxotere(R) (docetaxel), Avastin(R) (bevacizumab) or
Tarceva(R) (erlotinib) -- all in a single study. Approximately seventy
adult patients will be enrolled at ten centers.
"Polyamine analogs such as CGC-11047 represent an interesting approach
to halting cellular proliferation associated with cancer," said Dan Von
Hoff, M.D., Chief Scientific Officer for U.S. Oncology, Director, Division
of Translational Research at TGen and Professor of Medicine at The
University of Arizona in Tucson. "This is an innovative study design in
which we will evaluate CGC-11047 as part of multiple combination regimens
early in the compound's development. There may be clear advantages to this
protocol as most chemotherapeutic agents are administered with other drugs,
enabling oncologists to find the combinations that provide the greatest
benefit in treating a given cancer."
The Phase Ib study is intended to establish a recommended dose for
CGC-11047 in each of the combination regimens and to determine a
maximum-tolerated dose. In addition, pharmacokinetics and evidence of
anti-tumor activity will also be evaluated. CGC-11047 will be administered
intravenously weekly over a 28-day cycle. The doses of gemcitabine,
docetaxel, bevacizumab or erlotinib will remain fixed according to their
respective product labeling.
"We are excited to be undertaking this Phase Ib study to evaluate
CGC-11047 in combination with multiple standard chemotherapies," said
Edward F. Schnipper, M.D., President and Chief Executive Officer of
Cellgate. "CGC-11047 has been well-tolerated in single-agent Phase I
studies and has demonstrated promising pre-clinical anti-tumor activity as
a single agent. By establishing the safety of CGC-11047 in combination with
existing chemotherapeutics among a variety of cancer types -- as well as
looking for initial indications of clinical activity -- early on in the
clinical development process, we will be better prepared to move into
later-stage studies."
Polyamines are cell components considered essential for cell
proliferation and differentiation. Cellgate has developed polyamine analogs
that target proliferating cells. Cellgate's polyamine analogs are believed
to work by binding to nucleic acid, displacing polyamines from their
natural binding sites and preventing cell replication. CGC-11047 has been
generally well tolerated in prior Phase I clinical studies when tested as a
single agent among patients with advanced cancers. In preclinical studies,
CGC-11047 has shown promising activity in inhibiting cancer cell growth
against multiple tumor cell lines.
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
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