Genasense Combined with Temodar and Abraxane Shows Preliminary Evidence of High Response Rates and Extended Survival in Patients with Advanced Melanoma
One-hour Infusion Schedule to be Tested in Next Cohort
BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--Jun 3, 2009 - Genta Incorporated (OTCBB: GNTA) announced preliminary results that show a high objective response rate and potentially extended survival in an ongoing pilot study that incorporates the Company's lead oncology product, Genasense® (oblimersen sodium) Injection, in a chemotherapy program for patients with advanced melanoma. The data were featured this week in a presentation at the annual meeting of the American Society of Clinical Oncology (ASCO) in Orlando, FL.
Based on preclinical evidence of synergy, Genasense was combined with temozolomide (Temodar®; Schering Plough, Inc.), the most commonly used anticancer drug for melanoma, plus ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension [albumen bound]; Abraxis Bioscience, Inc.).
To date, 18 patients have been accrued, all of whom had unresectable stage 4 melanoma. None had previously received chemotherapy, and their baseline LDH did not exceed 1.1 times the upper limit of normal. (LDH is a tumor-derived biomarker that has been associated with outcome in melanoma and other diseases.) To date, 7 patients (39%) have achieved major objective responses: one with complete response (CR) after 6 cycles of treatment, and 6 with at least a partial response after a minimum of 2 treatment cycles. Five patients have maintained stable disease (SD) after at least 3 treatment cycles (24 weeks), for an overall disease control rate (CR+PR+SD) of 68%. The most commonly observed side-effects were similar to those associated with the chemotherapy drugs used alone, including leukopenia, thrombocytopenia, neuropathy, and hair loss.
Overall median survival for all patients irrespective of response was 14.7 months, and 50% of patients have survived greater than 1 year. The patient who achieved a complete response has stopped all therapy and remains without recurrence for 20+ months. The single patient with ocular melanoma, a rare and highly aggressive subtype, survived for 15 months. These data compare very favorably with median survival reported in the randomized Phase 3 trial of patients with advanced melanoma and similar LDH criteria using dacarbazine alone (9.7 months) or dacarbazine plus Genasense (11.4 months) (Bedikian A, et al., J Clin Oncol. 24:4738, 2006).
“These initial data are very promising,” said Dr. Loretta M. Itri, Genta's President, Pharmaceutical Development. “Temozolomide is the active metabolite of dacarbazine that was used in our Phase 3 trial (AGENDA) in patients with advanced melanoma and low-normal LDH. Taxanes are being increasingly used in patients with metastatic melanoma, and this unique combination may offer substantial advantages. The next group of patients in this study will receive Genasense administered over 1 hour twice per week. This new, more convenient schedule is a key aspect of our clinical development plan.”
About the AGENDA trial in advanced melanoma
Genta has completed patient enrollment into AGENDA, a Phase 3, randomized, double-blind, placebo-controlled trial that is intended to support global registration of Genasense for patients with advanced melanoma. The study is designed to confirm certain safety and efficacy results from Genta's prior randomized trial of Genasense combined with dacarbazine in patients identified by a biomarker who have not previously received chemotherapy. The co-primary endpoints of AGENDA are progression-free survival (PFS) and overall survival. Genta anticipates that the final analysis of PFS will be available in the 4th quarter 2009, and if clinically meaningful, the Company plans to submit its regulatory applications based on this outcome.
Malignant melanoma is the most deadly form of skin cancer. The incidence of this disease is increasing by approximately 4% annually in the US. In 2004, the American Cancer Society estimates more than 55,000 cases of malignant melanoma will have been diagnosed. 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.
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 is pursuing a broad clinical development program with Genasense evaluating its potential to treat various forms of cancer.
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. 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 G4544, an oral formulation of the active ingredient in Ganite, that has recently entered clinical trials as a potential treatment for diseases associated with accelerated bone loss. The Company is also developing tesetaxel, a novel, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel. 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.
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:
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.
Contact: Genta Investor Relations
Posted: June 2009