Advertisement
The new Genasense trial, known as AGENDA, is a randomized, double-blind,placebo-controlled study in which patients are randomly assigned to receiveGenasense plus dacarbazine (DTIC) or DTIC alone. AGENDA is designed toconfirm the safety and efficacy of Genasense when combined with DTIC inpatients who have not previously received chemotherapy. The trial will accrueapproximately 300 patients who have been defined using a biomarker and will beconducted at approximately 100 sites worldwide, including North America,Europe and Australia. Patient enrollment into AGENDA has been initiated.
Advertisement
About Genasense in Advanced Melanoma
Genasense, Genta's lead anticancer drug, is a novel targeted therapy thatblocks the production of Bcl-2, a protein that appears to be a fundamentalcause of cancer treatment resistance. By knocking down Bcl-2, Genasense mayenhance the effectiveness of chemotherapy in patients with advanced melanoma.Genasense in melanoma has Orphan Drug designations in Australia and the U.S.,along with Fast Track designation in the U.S.
In its initial Phase 3 trial, Genta performed the largest randomizedcontrolled trial that has ever been conducted in patients with advancedmelanoma. In that trial, 771 patients were randomly assigned to receivechemotherapy with DTIC alone or in combination with Genasense. A scientificarticle that describes efficacy and safety results from this study can beaccessed at: http://www.jco.org/cgi/content/abstract/JCO.2006.06.0483v1.
In that trial, patients were prospectively stratified according to levelsof a blood enzyme known as LDH. Further analysis of this study showed thatmaximum benefit accrued to patients whose LDH biomarker did not exceed 80% ofthe upper limit of normal. Efficacy results in this group of 274 patients,which are the focus of the confirmatory AGENDA trial, are displayed in thetable below. (The hazard ratios indicate that the addition of Genasense toDTIC was associated with a 42% reduction in the risk of disease progressionand a 36% reduction in risk of death.)
About Melanoma
Malignant melanoma is the most deadly form of skin cancer. The incidenceof this disease is increasing by approximately 4% annually in the U.S. In2004, the American Cancer Society estimates more than 55,000 cases ofmalignant melanoma will have been diagnosed. Melanoma is the number one causeof cancer death in women aged 25 to 29. More information about melanoma canbe accessed at the Melanoma Research Foundation: http://www.melanoma.org.
About the EADO
The EADO is an international cooperative group dedicated to promote,coordinate and improve clinical and laboratory research activities in skincancer. Further information about the EADO can be viewed at:http://www.eado.org/.
About Genta
Genta Incorporated is a biopharmaceutical company with a diversifiedproduct portfolio that is focused on delivering innovative products for thetreatment of pati
