Genasense® Given as High-Dose IV Infusion with Chemotherapy Shows Promising Activity in Advanced Melanoma
Data Presented at International Melanoma Conference in Berlin Results Follow Decision by Company to Continue Phase 3 AGENDA Trial for Overall Survival
BERKELEY HEIGHTS, NJ – November 20, 2009 – Genta Incorporated (OTCBB: GETA.OB) announced preliminary results that show a high objective response rate in a pilot study of patients with advanced melanoma that incorporates the Company’s lead oncology product, Genasense® (oblimersen sodium) Injection, administered for the first time as a 1-hour high-dose intravenous (IV) infusion. The data were featured this week in a presentation at the annual World Meeting of Interdisciplinary Melanoma/Skin Cancer Centers in Berlin, Germany.
Based on preclinical evidence of synergy, this study combined Genasense with temozolomide (Temodar®; Schering Plough, Inc.), the most commonly used anticancer drug for melanoma, and Abraxane® (paclitaxel protein-bound particles for injectable suspension [albumen bound]; Abraxis Bioscience, Inc.). Previous results using a standard dose and schedule of Genasense (i.e., approximately 500 mg infused over 24 hours daily for 7 days) suggested this investigational combination was associated with clinical activity and good tolerability in 18 patients.
In the new schedule, Genasense was administered with the same chemotherapy as a brief IV infusion over 1-hour twice per week for 4 consecutive weeks at a dose of 900 mg. This schedule compresses approximately 48 hours of standard dosing into a brief 1-hour infusion.
To date, 10 patients with Stage IV metastatic melanoma have been accrued to this ongoing trial.
Three patients achieved confirmed partial responses after the first 2 treatment cycles with current durations lasting from 24 to 40 weeks. One patient has maintained stable disease that has lasted 16 weeks, two patients have progressed, and four patients are too early to evaluate, having received only a single cycle. Only one episode (i.e., Grade 3 neutropenia) of any Grade 3-4 adverse event has been observed.
“With a preliminary disease control rate (defined as complete or partial responses plus stable disease lasting at least 3 months) of 67%, we view these data as very promising,” said Dr.
Loretta M. Itri, Genta’s President, Pharmaceutical Development. “Temozolomide is the active metabolite of dacarbazine that has been used in our Phase 3 trial in patients with advanced melanoma. I am pleased to confirm that Genta will continue the Phase 3, randomized, doubleblind AGENDA trial in order to determine overall survival in that study. Finally, taxanes are being increasingly used in patients with metastatic melanoma. We intend to initiate a Phase 2 study of our proprietary oral taxane, tesetaxel, in advanced melanoma. We hope our comprehensive approach with these new medicines may improve the management of this devastating disease.” About the AGENDA trial in advanced melanoma Genta has completed enrollment into AGENDA, a Phase 3, randomized, double-blind, placebocontrolled trial of Genasense in patients with advanced melanoma. Initial results did not show statistically significant differences in overall response or progression-free survival. The endpoints of durable response (complete or partial response lasting > 6 months) and overall survival are too early to evaluate. An analysis for futility has been conducted for the survival endpoint, and the trial has passed that analysis. The Company has announced it plans to continue to follow patients on AGENDA in order to determine this endpoint.
About the World Meeting of Interdisciplinary Melanoma/Skin Cancer Centers This international conference is organized annually by the European Association of Dermatologic Oncology (EADO), which is a co-leader of the AGENDA trial. The meeting offers melanoma clinicians and researchers from multidisciplinary melanoma/skin cancer centers an opportunity to interact, establish collaborations, and set an agenda for the further evolution of melanoma care and research. Genta is a Co-Sponsor of the EADO meeting.
About Melanoma Malignant melanoma is the most deadly form of skin cancer. The incidence of this disease is increasing by approximately 4% annually in the U.S. Melanoma is the number one cause of cancer death in women aged 25 to 29. More information about melanoma can be accessed at the Melanoma Research Foundation: http://www.melanoma.org.
About Genasense 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 anticancer treatment. Genta has pursued a broad clinical development program with Genasense evaluating its potential to treat various forms of cancer.
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. Two major programs anchor the Company’s research platform: DNA/RNA-based Medicines and Small Molecules. Genasense® (oblimersen sodium) Injection is the Company's lead compound from its DNA/RNA Medicines program. Genasense is being developed as an agent that may enhance the effectiveness of current anticancer therapy. The leading drug in Genta’s Small Molecule program is Ganite® (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of symptomatic patients with cancer related hypercalcemia that is resistant to hydration. The Company has developed oral formulations of the active ingredient in Ganite, which have completed preliminary clinical trials, as a potential treatment for diseases associated with accelerated bone loss. The Company is developing tesetaxel, a novel, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel. Genta intends to evaluate the clinical activity of tesetaxel in a range of human cancers. Ganite and Genasense are available on a “named-patient” basis in countries outside the United States.
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Posted: November 2009