Clinical Study Results Show Genasense(TM) May Delay Progression in Patients With Aggressive Non-Hodgkin's Lymphoma New Trial Examines Genasense Alone and in Combination with CHOP/ Rituxan(R)
CHICAGO, Jun 2, 2003 /PRNewswire-FirstCall via COMTEX/ -- Genta Incorporated
(Nasdaq: GNTA) today announced the presentation of preliminary clinical data
supporting the activity of its lead anticancer drug, Genasense(TM) (oblimersen
sodium), both as a single agent and in combination with chemotherapy in patients
with mantle cell lymphoma (MCL). Data from this multicenter Phase 2 trial were
presented today by Dr. John Leonard from New York Presbyterian Medical Center,
Cornell University Medical College, at the Annual Meeting of the American
Society of Clinical Oncology (ASCO) in Chicago, IL.
Genasense blocks the production of Bcl-2 -- a cancer protein that is believed to
contribute to the inherent resistance of cancer cells to anticancer treatment.
Preclinical studies have shown that Bcl-2 is responsible for multidrug
resistance in lymphoma cells, and that Genasense synergizes with both
chemotherapy and Rituxan(R) (rituximab; Genentech/Idec) by inhibiting Bcl-2
expression. Genasense is being broadly tested as a drug that can amplify the
effectiveness of current cancer therapy.
MCL is an aggressive form of non-Hodgkin's lymphoma (NHL) that is highly
resistant to chemotherapy and generally considered incurable with conventional
treatment. The clinical study reported today was designed to initially evaluate
the effects of Genasense used without chemotherapy, given every 3-4 weeks. A
maximum of 6 cycles of Genasense could be administered in the absence of disease
progression. If the disease progressed, patients who were diagnosed and who had
not previously received chemotherapy then received a combination of Genasense
plus R-CHOP (a standard regimen consisting of Rituxan(R), cyclophosphamide,
doxorubicin, vincristine, and prednisone). Patients who had previously failed
chemotherapy were removed from the study and received other care.
A total of 37 patients were enrolled into this trial. To date, 25 patients are
evaluable for response; 14 of these patients are still receiving treatment.
Across all treatment groups, 10 of the 25 patients (40%) remained stable without
progression during all 6 treatment cycles of Genasense when the drug was used
alone. These included 4 of 9 newly diagnosed patients (44%) and 6 of 16
previously treated patients (38%).
Seven newly diagnosed patients have crossed over to receive Genasense plus
R-CHOP. Two of these patients have achieved a complete response (29%), 2 have
achieved a partial response (29%), and 3 are too early to evaluate (42%).
Of the 16 previously treated patients (who received a median of 2 prior
regimens) 1 patient (6%) achieved a complete response, and 6 patients (38%)
achieved stable disease when receiving Genasense alone.
"For a disease characterized by inexorable progression, the high degree of
stabilization observed using Genasense alone is highly encouraging," commented
Dr. Leonard. "The incremental contribution to R-CHOP in newly diagnosed patients
will be properly tested only with a prospective randomized trial. However, new
treatment options are desperately needed for patients with this incurable form
of lymphoma. Going forward, we plan to examine escalating doses of Genasense in
patients who have progressed on conventional chemotherapy."
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 (CLL), and non-small cell lung cancer. |
