Genasense Triple Combination Therapy in Advanced Melanoma Presented at Chemotherapy Foundation SymposiumGenasense Plus Temodar® and Abraxane® Show Promising Early Clinical Activity
BERKELEY HEIGHTS, NJ – November 8, 2007 – Genta Incorporated (NASDAQ: GNTA) today announced the presentation of clinical data using the Company’s lead oncology drug, Genasense® (oblimersen sodium) Injection in combination with Abraxane® (paclitaxel proteinbound particles for injectable suspension) (albumin-bound; Abraxis BioScience, Inc.) and Temodar® (temozolomide; Schering Plough, Inc.) in patients with advanced metastatic melanoma. The study represents the rapid translation of preclinical results that demonstrated marked anticancer synergy with this drug combination. The results will be presented by Dr. Anna C. Pavlick, New York University School of Medicine, at the Chemotherapy Foundation Symposium XXV, entitled “Innovative Cancer Therapy for Tomorrow”, at the Marriott Hotel, New York, NY on November 9, 2007.
To date, 8 patients have been accrued to this trial. Of the first 7 evaluable patients, 5 patients have demonstrated clinical benefit, including 3 partial responses that occurred after the first treatment cycle, which have lasted for 40, 24 and 16 weeks, respectively. Two other patients have maintained stable disease lasting for a minimum of 24 weeks. Two patients had progressive disease, and one patient is too early to evaluate. There have been no episodes of Grade 4 (i.e., life-threatening) side-effects. Four patients experienced Grade 3 leukopenia (i.e., reduction in white blood cell count), and 1 patient had Grade 3 thrombocytopenia (i.e., reduction in platelet count).
“Our goal with this trial is to evaluate the synergy of Genasense with drugs other than dacarbazine that are currently used for treatment of patients with advanced melanoma,” commented Dr. Pavlick. “Genasense has already demonstrated significant benefit when combined with dacarbazine, and we are pleased to be participating in the confirmatory AGENDA trial. The early data from our new 3-drug study are highly encouraging, and we hope to extend these observations by incorporating the brief IV infusion schedule for Genasense that has recently been developed. This new regimen may offer an active, safe, and convenient treatment for patients with this devastating disease.”
The activity of this triple drug combination is supported by preclinical data that were presented at the 18th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics.
Results from the previous randomized trial of Genasense plus dacarbazine can be accessed at: http://www.jco.org/cgi/content/abstract/JCO.2006.06.0483v1
About AGENDA: A randomized Phase 3 trial of Genasense in advanced melanoma The AGENDA This trial seeks to confirm the effectiveness and safety of the Genasense/dacarbazine combination in patients who had the greatest benefit in a preceding randomized trial. AGENDA will enroll approximately 300 patients at sites in North America, Europe and Australia using a biomarker that has been confirmed as a powerful indicator of outcome.
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. Genta is currently recruiting patients for a global Phase 3 trial of Genasense in patients with advanced melanoma. 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 an oral formulation of the active ingredient in Ganite that is currently undergoing initial clinical trials as a potential treatment for diseases associated with accelerated bone loss. Ganite® and Genasense® are available on a “named-patient” basis in countries outside the United States.
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. Forward-looking statements include, without limitation, statements about: · the Company’s ability to obtain necessary regulatory approval for Genasense® from the U.S. Food and Drug Administration (“FDA”) or European Medicines Agency (“EMEA”); · the safety and efficacy of the Company’s products or product candidates; · the Company’s assessment of its clinical trials; · the commencement and completion of clinical trials; · the Company’s ability to develop, manufacture, license and sell its products or product candidates; · the Company’s ability to enter into and successfully execute license and collaborative agreements, if any; · the adequacy of the Company’s capital resources and cash flow projections, and the Company’s ability to obtain sufficient financing to maintain the Company’s planned operations; · the adequacy of the Company’s patents and proprietary rights; · the impact of litigation that has been brought against the Company and its officers and directors and any proposed settlement of such litigation; · the Company’s ability to retain compliance with the NASDAQ’s listing qualifications; 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.
The Company does not undertake to update any forward-looking statements. 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 2006 and its most recent quarterly report on Form 10-Q. SOURCE: Genta Incorporated
Posted: November 2007