Single-Agent Activity of Genta's Lead Anticancer Compound, Genasense(TM),
Reported in Patients with Advanced Chronic Lymphocytic Leukemia
PHILADELPHIA, Dec. 9 /PRNewswire-FirstCall/ --
Genta Incorporated (NASDAQ:GNTA), in collaboration with Aventis (NYSE:AVE),
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 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. |
