Genasense(TM) Plus Chemotherapy Reported Active as Initial Treatment For Older Patients with Acute Myeloid Leukemia
BERKELEY HEIGHTS, N.J., Dec. 8 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq:GNTA) announced the presentation of results from several clinical studies that showed safety and potentially enhanced activity when chemotherapy was combined with Genasense(TM) (oblimersen sodium) as initial therapy for patients over the age of 60 with acute myeloid leukemia (AML). Investigators from the James Comprehensive Cancer Center, Ohio State University, Columbus, OH, presented the results on Saturday at the annual meeting of the American Society of Hematology in San Diego, CA.
Bcl-2, the target of Genasense therapy, has been shown to block the onset of leukemia cell death that would otherwise be initiated by chemotherapy. Genasense inhibits the production of Bcl-2 protein and may therefore overcome leukemic cell resistance. Genta is broadly testing the use of Genasense as a means of sensitizing cancer cells to chemotherapy.
In the clinical trial reported today, Genasense was given at a dose of 7 mg/kg over 10 consecutive days -- a higher total dose than has been administered in previous clinical trials. Escalating doses of chemotherapy drugs (daunorubicin and cytarabine) were administered for 7 consecutive days beginning on day 4 of treatment. To date, 29 patients have been treated and are evaluable for response and safety. Sixteen of these patients were diagnosed with "secondary" AML that is known to be highly resistant to conventional treatment. Sixteen of the 29 patients responded to therapy, with 13 patients achieving complete remission (CR). Of the 13 patients who achieved complete remission, 7 had secondary AML. Three additional patients showed no evidence of leukemia after treatment, but failed to achieve satisfactory recovery of normal blood counts. No unexpected or dose-limiting toxicities were observed in patients treated in this study.
Based on the results of this study, the daunorubicin/cytarabine chemotherapy regimen will be incorporated into a randomized trial with or without Genasense in patients with newly diagnosed AML who are 65 years or older. The trial will be conducted by the Cancer and Leukemia Group B (CALGB), the largest oncology cooperative group in the U.S.
"Older patients with AML are notoriously unresponsive to standard chemotherapy," observed Dr. Loretta M. Itri, Genta's President, Pharmaceutical Development. "These results were observed in a very compromised patient population and we are pleased with the decision of the CALGB to advance this combination into a randomized clinical trial."
About AML
Acute myeloid leukemia (AML) is a rapidly progressive cancer of the blood that is characterized by the uncontrolled proliferation of immature white blood cells, called blasts. The overproduction of these cells crowds the bone marrow, radically reducing the body's ability to form other normal and necessary blood cells. Remission rates in adult AML are inversely related to age, and substantially lower remission rates are observed in older patients. In clinical studies of AML, Bcl-2 expression in leukemia cells has been correlated with significantly poorer survival.
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 and non-randomized clinical trials, including malignant melanoma, multiple myeloma, chronic lymphocytic leukemia (CLL), and non-small cell lung cancer. The Company has initiated the filing of a New Drug Application to the U.S. Food and Drug Administration for treatment of patients with advanced malignant melanoma using Genasense plus dacarbazine.
About CALGB
The Cancer and Leukemia Group B (CALGB) is a national clinical research group sponsored by the National Cancer Institute. The Group's Central Office is headquartered at the University of Chicago and its Statistical Center is located at Duke University. The CALGB was founded in 1955 with a goal of bringing together clinical oncologists and laboratory investigators to develop better treatments for cancer. Since then, CALGB has grown into a national network of 29 university medical centers, over 185 community hospitals, and more than almost 3000 physicians who collaborate in clinical research studies aimed at reducing the morbidity and mortality from cancer, relating the biological characteristics of cancer to clinical outcomes, and developing new strategies for the early detection and prevention of cancer. CALGB research is focused on seven major disease areas: leukemia, lymphoma, melanoma, and cancers of the breast, lung, gastrointestinal tract, and genitourinary tract.
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 major programs that center on oligonucleotides (RNA and DNA-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 is exclusively marketing in the U.S. for treatment of patients with cancer-related hypercalcemia that is resistant to hydration. For more information about Genta, please visit our website at: www.genta.com.
This press release and the conference call to follow contain 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
CO: Genta Incorporated
ST: New Jersey
SU: SVY
Web site: genta.com
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12/08/2003 08:02 EST |
