Previously Untreated and Relapsed Patients to be Recruited for
Combination using Rituxan® plus Fludarabine
Berkeley Heights, NJ - July 30, 2003
- Genta Incorporated (Nasdaq: GNTA) today announced the initiation
of a new clinical trial with its lead anticancer drug, Genasense
TM
(oblimersensodium), in patients with chronic lymphocytic leukemia
(CLL). This Phase 2 study will evaluate the safety and efficacy of
Genasense in combination with rituximab (RituxanÒ; Genentech/Idec)
and fludarabine (Fludara®; Berlex, Inc.). Although relapsed
patients are eligible and will be separately analyzed, the trial
represents the first use of Genasense in previously untreated
patients with CLL using this new "standard-of-care" drug regimen.
The study will be conducted at Roswell Park Cancer Institute,
Buffalo, NY, Georgetown University's Lombardi Cancer Center,
Baltimore, MD, and the Long Island Jewish University - Queens
Medical Center, New York, NY. A randomized Phase 3 trial of
Genasense in combination with fludarabine and cyclophosphamide
completed enrollment earlier this year in patients with relapsed
CLL.
Genasense works by inhibiting the production of Bcl-2. This
protein is highly expressed in CLL, where it is thought to block
the initiation of chemotherapy- induced cell death. By reducing
Bcl-2 in leukemia cells, Genasense may enhance the effectiveness of
current anticancer treatments. Preclinical studies have shown that
Genasense increases the antitumor activity of both fludarabine and
rituximab in several types of cancer. In the new clinical trial,
patients will receive up to 6 cycles of the
Genasense/Rituxan/fludarabine combination.
"We hope that by blocking Bcl-2 production, Genasense will
enhance the response to both standard and novel cancer therapies,"
commented Dr. Loretta M. Itri, Genta's President, Pharmaceutical
Development. "Our development program has tested Genasense in
combination with a broad array of anticancer therapies in patients
with many different hematologic cancers and solid tumors. In the
U.S., the fludarabine/rituximab combination is rapidly becoming the
new standard for previously untreated patients with CLL. This new
trial complements our recently completed programs, and it positions
Genasense to be the key enhancing agent in this disease."
About CLL
CLL is the most common form of leukemia in adults. Approximately
7,000 patients are expected to be diagnosed this year. The disease
arises in lymphocytes, a type of white blood cell that normally
produces antibodies and serves important immune functions. Patients
with CLL typically develop symptoms that may progress over a period
of years, ultimately producing a generalized depression of
immunity, marked increases in the size of spleen, liver and lymph
nodes, and impaired production other normal blood cells.
Eventually, these problems may cause life-threatening
complications, such as overwhelming infections and fatal
bleeding.
About Genasense
Genasense inhibits 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 currently in multiple, late-stage, randomized clinical
trials including malignant melanoma, multiple myeloma, chronic
lymphocytic leukemia, and 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 programs that center
on oligonucleotides (DNA/RNA-based medicines) and small molecules.
Genasense
TM
(oblimersen sodium), the Company"s lead compound from its
oligonucleotide program, is being developed 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 expects 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
