BERKELEY HEIGHTS, N.J., Sept. 15 GentaIncorporated (OTC Bulletin Board: GNTA) announced today that the independentData Monitoring Board (DMB) for AGENDA, a Phase 3 trial of the Company's leadoncology product Genasense(R) (oblimersen sodium) Injection, has completed itsreview. During its review, the DMB evaluated safety data from the study andconducted an analysis for futility. With more than half of the initiallyplanned number of patients now enrolled, the Board recommended that the trialcontinue to completion of full enrollment.
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. A total of 300 patients areexpected to enroll in AGENDA.
Genta will provide a pooled update of blinded data from AGENDA, comparedwith data obtained in this biomarker-defined population from the Company'sprevious Phase 3 trial (see below), at an international scientific meeting,Perspectives in Melanoma XII, that is scheduled for October 2-4, 2008.
"We remain quite pleased with the high investigator enthusiasm forAGENDA," said Dr. Loretta M. Itri, M.D., Genta's President, PharmaceuticalDevelopment. "We currently anticipate that accrual will complete in the firstquarter of 2009."
AGENDA employs a biomarker to define those patients who derived maximumclinical benefit during a large randomized study of DTIC with or withoutGenasense, known as study GM301. These patients are characterized bylow-normal levels of LDH (lactate dehydrogenase), a tumor-derived enzyme thatis readily detected in blood. Analysis of the previous efficacy outcomesobserved in 274 patients from GM301, which AGENDA is designed to confirm,yielded the following 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 Perspectives in Melanoma Meeting
Held annually, Perspectives in Melanoma XII will provide an overview ofrecent advances and rigorous discussions of the most current and controversialtopics in the fields of melanoma diagnosis and therapy. Led by authoritiesand current investigators in the field, the program will explore several ofthe most promising new leads from the bench to the clinic. The conferenceswill be held October 2-4, 2008 in The Hague, The Netherlands:http://www.imedex.com/appweb/announcements/a030-01.asp.
Genasense inhibits production of Bcl-2, a protein made by cancer cellsthat is thought to block a key pathway of chemotherapy-induced cell death(apoptosis). 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 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 to the AGENDATrial, a global Phase 3 trial of Genasense in patients with advanced melanoma.The leading drug in Genta's Small Molecule program is Ganite(R) (galliumnitrate injection), whic