Two Studies Show Activity of Genasense(TM) in Acute Leukemia
9 Dec 2002, 08:02am ET
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TO BUSINESS, HEALTH AND MEDICAL EDITORS:
Two Studies Show Activity of Genasense(TM) in Acute Leukemia
New Results Show Clinical Activity of Genasense in Combination with
Chemotherapy in Previously Untreated Patients with Acute Myeloid Leukemia
PHILADELPHIA, Dec. 9 /PRNewswire-FirstCall/ --
Genta Incorporated (NASDAQ:GNTA) announced the presentation of two studies
that extended the activity of Genasense(TM) in acute myeloid leukemia (AML).
Results were presented on Saturday at the 44th annual meeting of the American
Society of Hematology (ASH) in Philadelphia, PA.
The first study was presented by investigators from the University of
Pennsylvania who are conducting the recently initiated clinical study of
Genasense in children with advanced cancer. A particularly lethal form of
leukemia in small children is characterized by a specific genetic abnormality,
the MLL translocation. In the current preclinical study, investigators showed
that Genasense down-regulated the Bcl-2 protein in MLL leukemia cells by
approximately 60%, and that the drug directly killed the leukemia cells.
The second study reported preliminary clinical results from an ongoing
Phase 1 study testing Genasense in combination with increasing doses of two
standard chemotherapy drugs (daunorubicin and cytosine arabinoside [ARA-C]) in
the so-called "7 and 3" regimen. Patients were eligible for the study if they
were older than 60 years of age and had not previously received chemotherapy.
Many of these patients had pre-existing blood diseases, multiple genetic
abnormalities, and a variety of other medical complications, all of which have
are known to contribute to poor outcomes with standard chemotherapy.
To date, the combined Genasense/chemotherapy program has not caused more
side-effects than expected from using chemotherapy alone, which is a critical
factor for this group of patients. Overall, 5 of the first 11 evaluable
patients have achieved complete remission (CR); accrual of additional patients
is continuing at higher dose levels. Genasense was shown to decrease the
expression of Bcl-2 protein in blood cells, especially when these cells were
segregated between leukemic and normal cell populations prior to analysis.
This trial, which was conducted at Ohio State University and the University of
Chicago, was sponsored by the U.S. National Cancer Institute (NCI), pursuant
to Genta's Cooperative Research and Development Agreement (CRADA) with the
NCI.
"This trial was designed as a preliminary lead-in study conducted to
evaluate safety and biokinetics of Bcl-2 as a lead-in to a larger trial", said
Dr. Guido Marcucci, Assistant Professor at the Ohio State University School of
Medicine. "These new data provide strong support for further testing of this
program in a randomized controlled trial in newly diagnosed patients."
"These studies significantly expand our existing programs in AML," said
Dr. Loretta M. Itri, Genta's Executive Vice-President for Medical Affairs.
"Initial clinical work from Ohio State first established the safety of
Genasense in combination with fludarabine and ARA-C. That early study showed
a 50% CR rate in heavily pre-treated AML patients who were treated at the
highest dose levels. Based on the current data, we have indicated our intent
to support Dr. Marcucci's new proposal to further evaluate the "7 and 3"
chemotherapy program within the NCI cooperative group mechanism."
About AML
Acute myeloid leukemia (AML) is a rapidly progressive cancer of the blood
that is characterized by the uncontrolled proliferation of immature white
blood cells, called blasts. The overproduction of these cells crowds the bone
marrow, radically reducing the body's ability to form other normal and
necessary blood cells. Remission rates in adult AML are inversely related to
age, and substantially lower remission rates are observed in older patients.
In clinical studies of AML, Bcl-2 expression in leukemia cells has been
correlated with significantly poorer survival.
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), 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 gallium-containing compounds and Androgenics compounds
for prostate cancer. For more information about Genta, please visit our
website at: www.genta.com. |
