GenasenseTreatment for Chronic Lymphocytic Leukemia
Genta and Aventis Announce Genasense Expanded Access Program for Patients with Advanced Melanoma
BERKELEY HEIGHTS and BRIDGEWATER, N.J., April 20, 2004 -- Genta Incorporated and Aventis today announced the availability of Genasense (oblimersen sodium) Injection for use in combination with dacarbazine (DTIC) through an Expanded Access Program (EAP) for eligible patients in the U.S. with advanced melanoma who have not previously received chemotherapy. Genasense in combination with dacarbazine has been granted priority review by the U.S. Food and Drug Administration (FDA) for potential approval for the treatment of advanced melanoma.
Expanded access programs are designed to make investigational agents available at the earliest opportunity for the treatment of patients with diseases for which no comparable or satisfactory alternative drug is available.
Genasense is being made available for use in combination with dacarbazine at certain clinical sites throughout the U.S. for eligible patients with Stage IV and unresectable Stage III melanoma who have not been previously treated with dacarbazine or temozolomide-containing chemotherapy regimens. For more information regarding enrollment and additional details on the Genasense Expanded Access Program, please call: 1-800-RX-TRIALS.
Genasense has been studied in this patient population through the largest randomized trial ever conducted for advanced melanoma. In this phase 3 trial, 771 patients who had not previously received chemotherapy were randomized to receive either Genasense plus dacarbazine or dacarbazine alone.
"Advanced melanoma is a devastating disease that is very resistant to treatment," said Dr. Evan Hersh, Director, Melanoma Program, Arizona Cancer Center. "Our center participated in the Genasense trial, and we were very encouraged by the results. Genasense may represent a significant step forward in the way in which we treat this disease."
"There has been almost no progress in the treatment of melanoma in the past 30 years," stated Karen Graham, President of The Billy Foundation for Melanoma Research. "A potential new treatment is welcome news and offers hope to the melanoma community."
In this phase 3 clinical trial, when Genasense was combined with dacarbazine, the most frequent serious adverse event occurring in more than 5 percent of patients was fever (5.9 percent); the most frequent Grade 3 or 4 adverse events occurring in more than 5 percent of patients were neutropenia (21.3 percent), thrombocytopenia (15.6 percent), leukopenia (7.5 percent), anemia (7.0 percent), and nausea (7.0 percent).
Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current treatments for advanced melanoma.
About Advanced Melanoma
Advanced -- or malignant -- melanoma is the most deadly form of skin cancer. The incidence of melanoma has increased more rapidly than any other cancer, and has more than doubled in the last 30 years. According to the American Cancer Society, more than 55,000 cases of melanoma will be diagnosed in 2004. Melanoma is the number one cause of cancer death in the United States for women aged 25 to 29, and it ranks second in incidence to breast cancer in women aged 30-34.
Genta Incorporated is a pharmaceutical 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 (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(R) (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.
Aventis is dedicated to treating and preventing disease by discovering and developing innovative prescription drugs and human vaccines. In 2003, Aventis generated sales of euro 16.79 billion (US $18.99), invested euro 2.86 billion (US $3.24) in research and development and employed approximately 69,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. The company's prescription drugs business is conducted in the U.S. by Aventis Pharmaceuticals Inc., which is headquartered in Bridgewater, New Jersey. For more information, please visit www.aventis-us.com
Posted: April 2004
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