Agennix Expands Talactoferrin Phase 3 FORTIS-M Registration Trial Globally
(Thomson Reuters ONE) - Agennix AG / Agennix Expands Talactoferrin Phase 3 FORTIS-M Registration Trial Globally processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement. Martinsried/Munich (Germany), Princeton, NJ and Houston, TX, January 21, 2010 -Agennix AG (Frankfurt Stock Exchange: AGX) today announced that the next stageof the FORTIS-M trial has begun, with the first patient being dosed in Europe.FORTIS-M is a Phase 3 registration trial evaluating oral talactoferrin versusplacebo in advanced non-small cell lung cancer (NSCLC) in patients whose diseasehas progressed following two or more prior therapies. The trial is expected toenroll approximately 720 patients. Enrollment is ongoing at sites in the U.S.and is now being expanded into Europe and the rest of the world."Expansion of the FORTIS-M trial to sites outside the U.S. is an important stepin the continued development of talactoferrin for non-small cell lung cancer,"said Rajesh Malik, M.D., Chief Medical Officer. "Patient recruitment is ontrack and, assuming the trial proceeds as planned, completion of enrollment isanticipated to occur sometime in the first half of 2011, with top line dataavailable by the end of 2011."About non-small cell lung cancerLung cancer is one of the most commonly diagnosed cancers worldwide and is theleading cause of cancer-related deaths around the globe. Recent statisticsestimate that over 219,000 people in the U.S. and over 265,000 people in theEuropean Union (EU) are diagnosed with lung cancer each year. Over 160,000people in the U.S. and approximately 236,000 in the EU are expected to die fromthis disease annually. According to the American Cancer Society, non-small celllung cancer (NSCLC) accounts for 85% of all newly diagnosed lung cancer in theUnited States. Over 50% of NSCLC cases are already metastatic and not curablewhen diagnosed, and the 5-year survival rate in the U.S. is only about 15%.Despite recent advances in the treatment of this disease, NSCLC continues to bea major area of unmet medical need around the world.About the FORTIS-M trialFORTIS-M is a global, multicenter, randomized, double-blind, placebo-controlledPhase 3 trial evaluating oral talactoferrin plus best supportive care comparedto placebo plus best supportive care in patients with Stage IIIB/IV non-smallcell lung cancer whose disease has progressed after two or more prior treatmentregimens. The study is expected to enroll approximately 720 patients at clinicalsites around the world. The primary endpoint of the study is overall survival.For more information about the trial, please visit www.clinicaltrials.gov.About talactoferrinTalactoferrin is an oral novel targeted dendritic cell recruiter and activator(DCRA) being studied mainly for the treatment of cancer and severe sepsis.Talactoferrin has demonstrated anti-cancer activity in two randomized,double-blind, placebo-controlled Phase 2 studies in NSCLC. In the Phase 2 trialin 100 patients with NSCLC whose disease had progressed following one or moreprior therapies, talactoferrin showed a statistically significant improvement inoverall survival compared to placebo (median survival of 6.1 vs. 3.7 months,hazard ratio: 0.68, one-tailed p-value=0.04). Talactoferrin appeared to bewell tolerated in this study. The total occurrence of adverse events and severeadverse events (Grade 3/4/5) was statistically significantly lower in thetalactoferrin arm compared to the placebo group (p-value=0.0013 andp-value=0.0005, respectively). No talactoferrin-related serious adverse eventswere reported in either Phase 2 trial in NSCLC. As a result of the promisingresults from Phase 2 studies, two Phase 3 studies with talactoferrin in NSCLChave been initiated. Talactoferrin has also shown activity in renal cellcarcinoma, as well as severe sepsis and has been shown to be very well toleratedin all of these patient populations. The Company also has an investigationaltopical formulation of talactoferrin for diabetic foot ulcers.About AgennixAgennix AG is a publicly traded biopharmaceutical company that is developingnovel therapies in areas of major unmet medical need to improve the length andquality of life of seriously ill patients. The Company's most advanced programis talactoferrin, an oral targeted therapy that is in Phase 3 clinical trials innon-small cell lung cancer. Other clinical development programs includeRGB-286638, a multi-targeted kinase inhibitor in Phase 1 testing; the oralplatinum-based compound satraplatin; and a topical gel form of talactoferrin fordiabetic foot ulcers. Agennix is a transatlantic company with sites in Munich,Germany; Princeton, New Jersey and Houston, Texas. For additional information,please visit the Agennix Web site at www.agennix.com.This press release contains forward-looking statements, which express thecurrent beliefs and expectations of the management of Agennix AG. Suchstatements are based on current expectations and are subject to risks anduncertainties, many of which are beyond our control, that could cause futureresults, performance or achievements to differ significantly from the results,performance or achievements expressed or implied by such forward-lookingstatements. There can be no guarantee that the FORTIS-M trial will be completedin a timely manner, if at all, or that, if completed, as to what the trialresults will be or that talactoferrin will ultimately be approved for sale inany country. Actual results could differ materially depending on a number offactors, and we caution investors not to place undue reliance on theforward-looking statements contained in this press release. Forward-lookingstatements speak only as of the date on which they are made and Agennixundertakes no obligation to update these forward-looking statements, even if newinformation becomes available in the future.For further information, please contact:AgennixAGInvestor Relations & Corporate CommunicationsPhone: +49 (0)89 8565 2693ir(at)agennix.comIn the U.S.: Laurie DoyleDirector, Investor Relations & Corporate CommunicationsPhone: +1 609 524 5884laurie.doyle(at)agennix.com Additional media contacts for Europe:MC Services AGPhone: +49 (0) 89 210 228 0Raimund Gabrielraimund.gabriel(at)mc-services.euHilda Juhaszhilda.juhasz(at)mc-services.eu Additional investor contact for Europe:Trout International LLCLauren Williams, Vice PresidentPhone: +44 207 936 9325lwilliams(at)troutgroup.com [HUG#1375567] --- End of Message --- Agennix AGFraunhoferstr. 20 Martinsried GermanyISIN: DE000A1A6XX4;Listed: Prime Standard in Frankfurter Wertpapierb?,Regulierter Markt in Frankfurter Wertpapierb?;
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Datum: 21.01.2010 - 04:15 Uhr
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