New Study Shows Biomarkers May Determine Responsiveness to Ganite(TM) In Non-Hodgkin's Lymphoma
BERKELEY HEIGHTS, N.J., Apr 10, 2003 /PRNewswire-FirstCall via COMTEX/ -- Genta
Incorporated (Nasdaq: GNTA) today announced presentation of laboratory data
suggesting that it may be possible to determine patterns of response and
resistance to Genta's newest anticancer drug, Ganite(TM) (gallium nitrate
injection), in patients with refractory non-Hodgkin's lymphoma (NHL). The
results were published in the March 2003 issue of the Proceedings of the Annual
Meeting of the American Association for Cancer Research (AACR). The data were
reported from the laboratory of Dr. Christopher Chitambar, Professor of Medicine
at the Medical College of Wisconsin in Milwaukee, who is also a leader in the
current clinical study of Ganite in patients with refractory NHL.
Ganite was originally developed as a form of cancer chemotherapy by the National
Cancer Institute. In a series of Phase 1 and Phase 2 trials, more than 1,000
patients were treated with the drug. A particularly high level of activity,
including major response rates of approximately 40 to 50 percent, was reported
by several investigators, including Dr. Chitambar, in patients with advanced
NHL.
Previous data have shown that Ganite's anticancer activity results from blocking
at least two enzymes: ribonucleotide reductase, an enzyme that is highly
expressed in cancer cells, as well as a phosphotyrosine kinase. In the new
series of experiments, a highly robust cDNA microarray (consisting of 19,200
genes) was used to characterize patterns of response and resistance in two types
of NHL cells. Preliminary results have shown that the efficacy of the drug in
NHL was linked to certain genes involved in apoptosis (programmed cell death),
as well as so-called "endosomal trafficking." An abstract of the data can be
viewed at:
aacr03.agora.com
"This preliminary pharmacogenomic study indicates that it may be possible for us
to predict which patients with NHL may best respond to treatment with gallium
nitrate," said Dr. Chitambar. "This agent has displayed some of the highest
activity of any single agent we've studied in patients with NHL, and we are
quite enthusiastic about pursuing it in our clinical program."
"Gallium is known to actively accumulate at sites of disease in patients with
NHL, and a 'gallium scan' has traditionally been one of the most common
diagnostic tests for clinically staging the disease," commented Dr. Raymond P.
Warrell Jr., Genta's Chief Executive Officer. "These data suggest that Ganite
may represent a 'targeted therapy' for patients with NHL, and we are committed
to aggressively developing that new clinical indication."
About Ganite
Genta has submitted a supplemental NDA for Ganite in the U.S. as an intravenous
treatment for patients with cancer-related hypercalcemia that is resistant to
hydration. Hypercalcemia is a life-threatening elevation of blood calcium that
can occur in patients with advanced cancer. Assuming there are no important
delays in the review of its submission, Genta believes the Company will be able
to market the drug during the second half of 2003 for hypercalcemia treatment.
In 2002, Genta filed a new Investigational New Drug (IND) application with FDA's
Division of Oncology Drug Products, and the Company has initiated a multicenter
clinical trial to further evaluate the activity of Ganite in patients with
refractory NHL.
About Genta
Genta Incorporated is a biopharmaceutical company with a diversified product
portfolio that is focused on anticancer therapy. The Company's research platform
is anchored by oligonucleotide chemistry, particularly applications of antisense
and decoy aptamer technology. Genasense(TM) (oblimersen sodium), the Company's
lead compound, is being developed in collaboration with Aventis and is currently
undergoing late-stage, Phase 3 clinical testing in several clinical indications.
Genta's pipeline also comprises a portfolio of small molecules, including
Ganite(TM) (gallium nitrate injection), oral gallium-containing compounds, and
Androgenics compounds for prostate cancer. For more information about Genta,
please visit our website at: www.genta.com. |
