Genta Updates Progress of its Phase 3 Trial of Genasense(R) in Patients with Advanced Melanoma
AGENDA is a Phase 3, randomized, double-blind, placebo-controlled trialthat is intended to support global registration of Genasense for patients withadvanced melanoma. The study is designed to confirm certain safety andefficacy results from Genta's prior randomized trial of Genasense combinedwith dacarbazine (DTIC) in patients identified by a biomarker who have notpreviously received chemotherapy. The co-primary endpoints of AGENDA areprogression-free survival and overall survival. The trial is being led by theEADO in Europe and by the M.D. Anderson Cancer Center, Houston, TX in the U.S.
To date, more than one-third of the expected total number of patients havenow been randomized onto the AGENDA trial. A total of 83 sites in 12countries have been opened in Europe, the U.S., Canada, and Australia.Clinical characteristics of the first 70 patients accrued to AGENDA (notidentified by treatment group) were shown to be similar to thebiomarker-defined population accrued in the previous Phase 3 trial ofGenasense, known as GM301. The incidence of serious adverse events in AGENDAhas been somewhat lower, which probably reflects the routine use of prescribedsupportive care for all patients, as well as the double-blind design of AGENDAcompared with the open-label design of GM301. Target accrual of 300 patientsis expected to complete in the fourth quarter of 2008, with initial dataexpected shortly thereafter.
AGENDA is a global Phase 3, randomized, double-blind trial in patientswith advanced melanoma. The study is designed to confirm certain safety andefficacy results from an antecedent randomized trial of Genasense combinedwith dacarbazine (DTIC) in patients who have not previously receivedchemotherapy (GM301). AGENDA employs a biomarker to define those patients whoderived maximum clinical benefit during the preceding study. These patientsare characterized by low-normal levels of LDH (lactate dehydrogenase), atumor-derived enzyme that is readily detected in blood. Analysis of thoseefficacy outcomes in GM301, which were observed in 274 patients, showed thefollowing results:
A scientific article that describes efficacy and safety results from GM301can be accessed at: http://www.jco.org/cgi/content/abstract/JCO.2006.06.0483v1
About the EADO
The EADO is an independent non-profit organization dedicated to thepromotion, coordination, and improvement of clinical and laboratory researchactivities in the field of skin cancer. The organization has an European andinternational membership of dermatologists, oncologists and clinical as wellas basic research scientists interested in the field of dermato-oncology.EADO provides leadership by formulating and disseminating quality standardsand guide-lines for diagnosis and treatment of skin cancer, and it providesdirection, coordination and organizations of clinical, therapeutic, andexperimental trials.
Genasense inhibits production of Bcl-2, a protein made by cancer cellsthat is thought to block chemotherapy-induced apoptosis (programmed celldeath). By reducing the amount of Bcl-2 in cancer cells, Genasense mayenhance the effectiveness of current anticancer treatment. Genta is pursuinga broad clinical development program with Genasense evaluating its potentialto treat various forms of cancer.
Genta Incorporated is a
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