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-- NDA amendment for Genasense(R) in CLL submitted to FDA
-- AGENDA Phase 3 trial of Genasense in melanoma updated at EADO
-- Clinical hold on tesetaxel, a leading, clinical-stage oral taxane,lifted by FDA
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"Genta has three high-value clinical-stage products, and we have nowsecured funding that should enable us to conclude both our NDA amendment forGenasense(R) in CLL, as well as enrollment into our Phase 3 program inmelanoma," said Dr. Raymond P. Warrell, Jr., Genta's Chairman and ChiefExecutive Officer. "FDA has targeted December 3, 2008 as the action date forthe CLL NDA amendment, and we expect to report AGENDA results in melanomaduring 2009. In response to Genta's regulatory submission, FDA has now liftedthe clinical hold on tesetaxel, which will allow us to resume clinical trialswith a leading oral taxane that addresses a large, well-characterized market.Our portfolio includes unique compounds that offer significant revenue andpartnering opportunities."
Highlights of the Genta programs appear below.
Genasense: The Leading Antisense Drug in Clinical Development
Genasense in Melanoma: Genta is currently enrolling patients withadvanced melanoma in a Phase 3 trial of Genasense plus chemotherapy, known asAGENDA. AGENDA is a randomized, double-blind, placebo-controlled trial thatis 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 in patients identified by a biomarker who have not previouslyreceived chemotherapy. The co-primary endpoints of AGENDA areprogression-free survival and overall survival. This global trial istargeting the recruitment of 300 patients from Europe, the U.S., Canada, andAustralia.
Genasense in Chronic Lymphocytic Leukemia (CLL): During the quarter,Genta submitted an amendment to its New Drug Application (NDA) for the use ofGenasense plus chemotherapy in patients with relapsed/refractory CLL. Thesubmission was based primarily on new information from the Company'scompleted, randomized Phase 3 trial that showed, among other findings, asignificant increase in overall survival for patients who achieved a completeor partial response when treated with Genasense plus chemotherapy comparedwith patients treated with chemotherapy alone. Subsequently, FDA has notifiedthe Company that it considers Genta's submission as a complete response and aClass 2 resubmission with a Prescription Drug User Fee Act (PDUFA) goal datefor FDA's response of December 3, 2008. The submission requests marketingapproval of Genasense for the proposed indication.
Tesetaxel: A Leading Oral Taxane with Anticancer Activity
In other regulatory activity, Genta submitted its response to a priornotice from FDA that had placed tesetaxel, a clinical-stage oral taxane, onfull "clinical hold". During the quarter, the Company was notified by FDAthat the clinical hold had been lifted and that Genta may resume clinicaltrials with tesetaxel.
Tesetaxel is the latest addition to the Genta oncology portfolio. Theagent was developed to avoid serious effects associated with other taxanes(such as paclitaxel [Taxol(R); Bristol Myers Squibb] and docetaxel[Taxotere(R); sanofi aventis]), including severe infusion reactions,peripheral nerve damage, and drug resistance. More than 250 patients havereceived tesetaxel, and the drug has demonstrated anticancer activity inseveral clinical trials. If further studies document efficacy and safety,tesetaxel offers substantial opportunities to impro
