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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.
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At the end of the first quarter, the trial had accrued approximately 50patients with approximately 60% of planned investigative sites having beeninitiated. Countries with sites currently open for enrollment include theU.S., Canada, Australia, France, Germany, Austria, and the Czech Republic. Thetrial is planned to open at approximately 90 sites worldwide, and mostremaining sites are expected to initiate within the next 30 days. Targetaccrual of 300 patients is expected to complete in the fourth quarter of 2008,with initial data expected shortly thereafter.
"Investigator enthusiasm for AGENDA is quite high, and we are currentlyrecruiting at our expected rate," said Dr. Loretta M. Itri, M.D., Genta'sPresident, Pharmaceutical Development. "We believe the current rate, combinedwith enrollment from new sites that will open in the near future, should allowus to maintain our timelines for completion of accrual."
About AGENDA
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 by low-normal levels of LDH (lactate dehydrogenase), a tumor-derived enzyme that isreadily 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 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 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), which the Company is exclusively marketing in the U.S. fortreatment of symptomatic patients with cancer related hypercalcemia that isresistant to hydration. The Company has developed G4544, an oral formulationof the active ingredient in Ganite, that has recently entered clinical trialsas 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 drug class as paclitaxel and docetaxel.Ganite and Genasense are available on a "named-patient" basis in countriesoutside the United States. For more information about Genta, please visit ourwebsite at: www.genta.com.
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This press release may contain forward-looking statements with respect tobusiness conducted by Genta Incorporated. By
