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To date, 8 patients have been accrued to this trial. Of the first 7evaluable patients, 5 patients have demonstrated clinical benefit, including 3partial responses that occurred after the first treatment cycle, which havelasted for 40, 24 and 16 weeks, respectively. Two other patients havemaintained stable disease lasting for a minimum of 24 weeks. Two patientshad progressive disease, and one patient is too early to evaluate. There havebeen no episodes of Grade 4 (i.e., life-threatening) side-effects. Fourpatients experienced Grade 3 leukopenia (i.e., reduction in white blood cellcount), and 1 patient had Grade 3 thrombocytopenia (i.e., reduction inplatelet count).
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"Our goal with this trial is to evaluate the synergy of Genasense withdrugs other than dacarbazine that are currently used for treatment of patientswith advanced melanoma," commented Dr. Pavlick. "Genasense has alreadydemonstrated significant benefit when combined with dacarbazine, and we arepleased to be participating in the confirmatory AGENDA trial. The early datafrom our new 3-drug study are highly encouraging, and we hope to extend theseobservations by incorporating the brief IV infusion schedule for Genasensethat 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 preclinicaldata that were presented at the 18th EORTC-NCI-AACR Symposium on MolecularTargets and Cancer Therapeutics. These data can be accessed at:http://www.genta.com/index.php?option=com_content&task=view&id=60&Itemid=73&CID=43&SHID=&COID
Results from the previous randomized trial of Genasense plus dacarbazinecan be accessed at:http://www.jco.org/cgi/content/abstract/JCO.2006.06.0483v1
About AGENDA: A randomized Phase 3 trial of Genasense in advancedmelanoma
The AGENDA This trial seeks to confirm the effectiveness and safety of theGenasense/dacarbazine combination in patients who had the greatest benefit ina preceding randomized trial. AGENDA will enroll approximately 300 patientsat sites in North America, Europe and Australia using a biomarker that hasbeen confirmed as a powerful indicator of outcome. More information aboutAGENDA can be accessed at:http://www.genta.com/index.php?option=com_content&task=view&id=38&Itemid=55
About Genta
Genta Incorporated is a biopharmaceutical company with a diversifiedproduct portfolio that is focused on delivering innovative products for thetreatment of patients with cancer. Two major programs anchor the Company'sresearch platform: DNA/RNA-based Medicines and Small Molecules. Genasense(R)(oblimersen sodium) Injection is the Company's lead compound from its DNA/RNAMedicines program. Genta is currently recruiting patients for a global Phase3 trial of Genasense in patients with advanced melanoma. The leading drug inGenta's Small Molecule program is Ganite(R) (gallium nitrate injection), whichthe Company is exclusively marketing in the U.S. for treatment of symptomaticpatients w
