Genta Announces the Initiation of NCI/CALGB Trial of Genasense(TM) Plus Gleevec(R) in Patients with Chronic Myeloid Leukemia
BERKELEY HEIGHTS, N.J., Oct 2, 2002 /PRNewswire-FirstCall via COMTEX/ -- Genta
Incorporated (Nasdaq: GNTA), in collaboration with Aventis (NYSE: AVE),
announced today the initiation of a new clinical trial that uses its lead
anticancer drug, Genasense(TM), in combination with Gleevec(R) (imatinib
mesylate; Novartis), in patients with chronic myeloid leukemia (CML). This
multicenter trial will be conducted by a national U.S. cooperative study group,
the Cancer and Leukemia Group B (CALGB), and will be sponsored by the U.S.
National Cancer Institute, pursuant to Genta's Cooperative Research and
Development Agreement (CRADA).
Gleevec was approved in record time in 2001 for the treatment of CML. However,
despite a large number of early responses, resistance to Gleevec treatment --
followed by subsequent leukemic relapse -- has emerged as a major clinical
problem. Earlier this year, a paper presented at the annual meeting of the
American Association of Cancer Research (AACR) showed that Gleevec resistance
could be reversed simply by the addition of Genasense. This combined treatment
produced striking apoptosis in leukemic cells and yielded prolonged survival in
a preclinical animal model of CML. The new study will assess the safety and
effectiveness of this drug combination in patients with clinically acquired
Gleevec resistance.
"Earlier studies with Gleevec have shown that patients whom do not achieve a
complete cytogenetic remission after initial therapy have a high risk of disease
progression," commented Dr. Meir Wetzler, Associate Professor of Medicine at the
Roswell Park Cancer Institute, Buffalo, NY. "It is our hope to reverse the
development of such resistance by treating patients with Genasense, and that
this will translate into a long-term clinical benefit."
"Rapid translation of the preclinical findings to the clinic is both exciting
and important to the future care of patients with this devastating problem,"
noted Dr. Loretta M. Itri, Genta's Chief Medical Officer. "It is a distinct
credit to our partnership with NCI and its CALGB investigators to have moved
this combination into the clinic so quickly after the initial preclinical
report. The ability to reverse resistance, or to prevent its emergence, would be
a significant achievement in this disease."
About CML
CML is responsible for approximately 20% of adult leukemias. CML occurs when
pieces of two different chromosomes break off and reattach on the opposite
chromosome, forming the so-called "Philadelphia" chromosome. This chromosomal
translocation leads to an abnormal cellular enzyme (a tyrosine kinase) being
"turned on" all the time. As a result, potentially life-threatening levels of
both mature and immature white blood cells develop in the bone marrow and the
blood. Gleevec is an inhibitor of several tyrosine kinases and has induced
remissions in a high proportion of patients with CML.
About Genasense
Genasense works by inhibiting the production of Bcl-2, a protein made by cancer
cells that blocks chemotherapy-induced cell death. By reducing the amount of
Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current
anticancer treatments, such as Gleevec.
About CALGB
The Cancer and Leukemia Group B (CALGB) is a national clinical research group
sponsored by the National Cancer Institute. The Group's Central Office is
headquartered at the University of Chicago and its Statistical Center is located
at Duke University. The CALGB was founded in 1955 with a goal of bringing
together clinical oncologists and laboratory investigators to develop better
treatments for cancer. Since then, CALGB has grown into a national network of 29
university medical centers, over 185 community hospitals, and more than almost
3000 physicians who collaborate in clinical research studies aimed at reducing
the morbidity and mortality from cancer, relating the biological characteristics
of cancer to clinical outcomes, and developing new strategies for the early
detection and prevention of cancer. CALGB research is focused on seven major
disease areas: leukemia, lymphoma, melanoma, and cancers of the breast, lung,
gastrointestinal tract, and genitourinary tract.
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: genta.com. |
