Four New Studies Will Be Conducted in Collaboration with the
NCI
BERKELEY HEIGHTS, NJ - June 26, 2003
- Genta Incorporated (Nasdaq: GNTA) announced today the initiation
of four new clinical trials with its lead anticancer drug,
Genasense
TM
(oblimersen sodium), administered alone or in combination with
standard chemotherapy. The studies will be conducted at leading
cancer centers in both the U.S. and Canada, and will involve
patients with both solid tumors as well as hematologic cancers. The
trials, which are being sponsored by the National Cancer Institute
(NCI), include the following studies:
- A Phase 2 trial of Genasense plus interferon-alpha in
patients with advanced kidney cancer. The study will be conducted
by a consortium lead by the City of Hope National Cancer Center
in Duarte, CA.
- A Phase 1-2 trial evaluating Genasense used alone for
treatment of patients with advanced Waldenstrom's
macroglobulinemia (a disease of malignant plasma cells that is
closely related to multiple myeloma). The study will be conducted
at the Mayo Clinic and the University of Maryland.
- A Phase 1 trial using Genasense plus gemcitabine (Gemzar®;
Eli Lilly, Inc.) in patients with advanced solid tumors, focusing
on patients with pancreatic cancer. The study will be conducted
at Stanford University.
- A Phase 1 trial of Genasense plus CHOP-R (a standard
chemotherapy program comprised of cyclophosphamide, doxorubicin,
vincristine, prednisone, and rituximab [Rituxan®;
Genentech/Idec]) in previously untreated patients with advanced
non- Hodgkin's lymphoma. Investigators at Stanford University and
the British Columbia Cancer Agency in Vancouver will conduct the
study.
"Each of these trials is being conducted pursuant to Genta's
Cooperative Research and Development Agreement (CRADA) with the
National Cancer Institute," commented Loretta M. Itri, M.D.,
Genta's President, Pharmaceutical Development. "Data from
preclinical studies suggest that Genasense may work synergistically
with a wide range of anticancer agents in a wide variety of
cancers. The initiation of these trials permits the further
exploration of Genasense in many patients whose needs are not
adequately addressed by current forms of medical therapy. "
About Genasense
Genasense
TM
works by inhibiting the production of Bcl-2, a protein made
by cancer cells that is thought to block chemotherapy-induced cell
death. By reducing the amount of Bcl-2 in cancer cells, Genasense
may enhance the effectiveness of current anticancer treatments.
Genasense is being developed in collaboration with Aventis and
currently in multiple, late-stage, randomized clinical trials in
patients with malignant melanoma, multiple myeloma, chronic
lymphocytic leukemia (CLL), non-small cell lung cancer.
About Genta
Genta Incorporated is a biopharmaceutical company with a
diversified product portfolio that is focused on delivering
innovative products for the treatment of patients with cancer. The
Company's research platform is anchored by two major programs that
center on oligonucleotides (RNA/DNA-based medicines) and small
molecules. Genasense
TM
(oblimersen sodium), the Company"s lead compound from its
oligonucleotide program, is being developed in collaboration with
Aventis and is currently undergoing late-stage, Phase 3 clinical
testing. The leading drug in Genta's small molecule program is
Ganite
TM
(gallium nitrate injection), which the Company intends to launch
later this year for treatment of cancer-related hypercalcemia that
is resistant to hydration. For more information about Genta, please
visit our website at:
http://www.genta.com/
.
This press release contains forward-looking statements with
respect to business conducted by Genta Incorporated. By their
nature, forward-looking statements and forecasts involve risks
and uncertainties because they relate to events and depend on
circumstances that will occur in the future. There are a number
of factors that could cause actual results and developments to
differ materially. For a discussion of those risks and
uncertainties, please see the Company"s Annual Report/Form 10-K
for 2002.
SOURCE: Genta Incorporated
