PHILADELPHIA, December 9, 2002
-- Genta Incorporated (Nasdaq:
GNTA
-
News
), in collaboration with Aventis (NYSE: AVE - News), announced the
presentation of new clinical data that shows activity of the
Company"s lead anticancer compound, Genasense
TM
, as a single agent in patients with advanced chronic lymphocytic
leukemia (CLL). The results were presented on Saturday at the 44th
annual meeting of the American Society of Hematology (ASH) in
Philadelphia, PA.
Genasense is currently being evaluated in a
randomized Phase 3 trial that is testing its ability to enhance the
effectiveness of standard chemotherapy. At the ASH meeting in 2001,
preliminary information from a Phase 1 trial suggested
Genasense alone -- without concomitant use of chemotherapy --
could directly kill leukemia cells in patients with CLL. This
unexpected activity prompted expansion of that trial into a formal
Phase 2 evaluation using the optimal Genasense dose. Preliminary
results from this multicenter trial were presented over the weekend
by Dr. Kanti Rai, Chief of Hematology/Oncology at the Long Island
Jewish Medical Center, who is a leading CLL expert and investigator
in the study.
Data were presented on the first 23 patients from
the trial, which showed the following results:
-- Despite having failed 4 or more prior
treatment regimens, 2 patients
(9%) achieved partial responses.
-- Eleven patients (48%) achieved stabilization
of their disease, 5 of
whom had failed 4 or more prior treatments.
-- Circulating CLL cells were reduced by more
than 50% in 9 patients
(39%).
-- Eight of 19 patients (42%) achieved greater
than 50% decrease in the
size of enlarged lymph nodes.
-- 8 of 16 patients (50%) achieved greater than
50% decrease in the size
of enlarged liver or spleen.
-- To date, the major side effects of
Genasense have been fatigue and
fever.
Genasense attacks a protein in cancer cells known
as Bcl-2. High levels of Bcl-2 are believed to be a prime cause of
the failure of standard therapy to kill cancer cells.
Genasense is being evaluated in randomized trials to determine
its ability to amplify the effectiveness of cancer treatment in
many diseases, including CLL.
"The preliminary evidence of single-agent agent
activity in CLL that we observed last year was quite unexpected,"
said Dr. Raymond P. Warrell, Jr. MD, Genta"s Chief Executive
Officer. "This new activity is highly gratifying and makes a
substantial contribution to the Company"s registration strategy for
Genasense in CLL. Broadly speaking, we are continuing our focus on
randomized controlled trials to establish that Genasense may
broadly increase the efficacy of chemotherapy. These new results
suggest that the potential benefit that may be seen using Genasense
TM
in combination with chemotherapy could represent the combined
effects of synergy plus single-agent activity."
About CLL
Chronic lymphocytic leukemia (CLL) arises in
lymphocytes, which are white blood cells that provide important
immune functions and make antibodies. Compared with normal
lymphocytes, CLL cells are unusually long-lived due to high
expression of Bcl-2. Patients with CLL typically have very high
numbers of leukemia cells that circulate in blood and can cause
massive enlargement of lymph nodes, spleen, and liver. Chronic
lymphocytic leukemia is the most common form of leukemia in adults,
affecting about 8,000 new patients each year in the U.S.
About Genasense
Genasense 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 currently in multiple
late-stage randomized clinical trials including malignant melanoma,
multiple myeloma, chronic lymphocytic leukemia (CLL) and non-small
cell lung cancer.
