Genasense® Given as High-Dose IV Infusion with Chemotherapy Shows Promising Activity in Advanced Melanoma
November 20, 2009 13:04 UTC
Data Presented at International Melanoma Conference in Berlin
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, double-blind 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, placebo-controlled 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. For more information about Genta, please visit our website at: www.genta.com.
Safe Harbor
This press release may 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. Such forward-looking statements include those that express plan, anticipation, intent, contingency, goals, targets, or future developments and/or otherwise are not statements of historical fact. The words “potentially”, “anticipate”, “could”, “calls for”, and similar expressions also identify forward-looking statements. The Company does not undertake to update any forward-looking statements. Factors that could affect actual results include, without limitation, risks associated with:
the Company’s ability to obtain necessary regulatory approval for its product candidates from regulatory agencies, such as the U.S. Food and Drug Administration and the European Medicines Agency;
the safety and efficacy of the Company’s products or product candidates;
the commencement and completion of any clinical trials;
the Company’s assessment of its clinical trials;
the Company’s ability to develop, manufacture, license, or sell its products or product candidates;
the Company’s ability to enter into and successfully execute any license and collaborative agreements;
the adequacy of the Company’s capital resources and cash flow projections, the Company’s ability to obtain sufficient financing to maintain the Company’s planned operations, the Company’s ability to obtain sufficient financing to fund the AGENDA trial, or the Company’s risk of bankruptcy;
the adequacy of the Company’s patents and proprietary rights;
the impact of litigation that has been brought against the Company; and
the other risks described under Certain Risks and Uncertainties Related to the Company’s Business, as contained in the Company’s Annual Report on Form 10-K and Quarterly Report on Form 10-Q.
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 on Form 10-K for 2008 and its most recent quarterly report on Form 10-Q.
Genta Investor Relations
908-286-3980
info@genta.com
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