BERKELEY HEIGHTS, N.J., Dec. 10 /PRNewswire/
- Genta Incorporated (Nasdaq: GNTA - news) today announced the
presentation of both clinical and preclinical data supporting the
activity of GenasenseTM, the Company"s lead antisense compound, in
acute myeloid leukemia (AML).
The results were presented this weekend at the 43rd annual
meeting of the American Society of Hematology (ASH) in Orlando,
Florida. Final results of a dose-ranging study in patients with
acute leukemia were published by a group from Ohio State
University. Twenty patients, all of whom had relapsed from
extensive prior treatment, received Genasense at daily doses of
either 4 or 7 mg/kg/day for 10 days, plus combination chemotherapy
with varying doses of two standard drugs, fludarabine and
cytarabine. Three of six patients treated with the highest doses of
all drugs achieved complete remission. The overall response rate
for all patients at all dose levels was 45%, despite prior
treatment with high-dose cytarabine in many patients.
A second presentation, from investigators at the University of
Texas M. D. Anderson Cancer Center, tested Genasense alone and in
combination with a monoclonal antibody (Mylotarg [gemtuzumab
ozogamicin; Wyeth Ayerst Laboratories, Inc.]) in AML cells. After
72 hours of treatment, Genasense decreased Bcl-2 protein (i.e. the
target of Genasense activity) in leukemia cells by 50%. Genasense
was then shown to amplify leukemic cell death that was induced by
Mylotarg. These data are similar to recent results that show
synergy with another monoclonal antibody, rituximab (Rituxan; IDEC
Pharmaceuticals), in two other preclinical studies.
"These abstracts are of interest for two reasons," noted Stanley
R. Frankel, M.D., Genta"s Director of Clinical Operations. "First,
we will shortly be initiating a new multicenter clinical trial of
Genasense used as front-line therapy in combination with two
standard drugs (cytarabine and daunorubicin) in older patients with
AML. Second, Genta is currently conducting a clinical trial of
Genasense in combination with Mylotarg in this same patient
population. Together, results showing synergy of Genasense in
combination with each of these agents provide strong support for
the use of these combinations."
