Ad hoc: Agennix AG: Agennix AG Announces Positive Results with Talactoferrin In
Randomized, Double-B
(Thomson Reuters ONE) - Agennix AG / Misc. matters / Ad hoc: Agennix AG Announces Positive Results with Talactoferrin InRandomized, Double-Blind, Placebo-Controlled Phase 2 Trial Ad hoc announcement according to §15 WpHG processed and transmitted by Hugin. The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------- Trial results show 45% overall reduction in 28-day allcause mortality with talactoferrin versus placebo- Talactoferrin again shown to be very well toleratedMartinsried/Munich (Germany), Princeton, NJ and Houston, TX, December1, 2009 - Agennix AG (Frankfurt Stock Exchange: AGX) today reportedresults from the talactoferrin randomized, double-blind,placebo-controlled Phase 2 trial in severe sepsis. The trialevaluated talactoferrin versus placebo in 190 adult patients withsevere sepsis enrolled at 25 leading centers across the U.S.Patients in both arms also received standard of care treatment forsevere sepsis in an intensive care unit (ICU) setting. The trialachieved its primary endpoint of a reduction in 28-day all-causemortality. The trial showed a 45% reduction in the 28-day all-causemortality from 26.6% in the placebo arm to 14.6% in the talactoferrinarm (two-tailed p-value = 0.04, odds ratio by logistic regressionanalysis = 0.47). The above analyses were conducted on anintent-to-treat (ITT), as treated basis.Talactoferrin was shown to be very well tolerated in the study withno major differences in adverse events between the two treatmentarms.END OF AD HOC ANNOUNCEMENTConference call scheduledThe Company has scheduled a conference call to which participants maylisten via live webcast, accessible through the Agennix Web site atwww.agennix.com or via telephone. A replay will be available on theWeb site following the live event. The call, which will be conductedin English, will be held on Wednesday, December 2, 2009 at 15:00CET/9:00 AM ET. The dial-in numbers for the call are as follows:Participants in Europe: 0049 69 667775756 0044 20 3003 2666Participants in the U.S.: 1-646 843 4608Please dial in 10 minutes before the beginning of the call.About AgennixAgennix AG is a publicly traded biopharmaceutical company focused ondeveloping novel anti-cancer therapies. The Company was formed by thecombination of GPC Biotech AG and Agennix Incorporated. The Company'smost advanced program is talactoferrin, an oral targeted therapy thatis in Phase 3 clinical trials in non-small cell lung cancer. Otherclinical development programs include RGB-286638, a multi-targetedkinase inhibitor in Phase 1 testing; the oral platinum-based compoundsatraplatin; and a topical gel form of talactoferrin for woundhealing. Agennix is a transatlantic company with sites in Munich,Germany; Princeton, New Jersey and Houston, Texas. For additionalinformation, please visit the Agennix Web site at www.agennix.com.This ad hoc announcement contains forward-looking statements, whichexpress the current beliefs and expectations of the management ofAgennix AG. Such statements are based on current expectations and aresubject to risks and uncertainties, many of which are beyond ourcontrol, that could cause future results, performance or achievementsto differ significantly from the results, performance or achievementsexpressed or implied by such forward-looking statements. There can beno guarantee that the Company will move talactoferrin forward indevelopment for severe sepsis in a timely manner, if at all, or thattalactoferrin will ultimately be approved for sale in any 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-looking statements speak only as of the date on which theyare made and Agennix undertakes no obligation to update theseforward-looking statements, even if new information becomes availablein the future.For further information, please contact:Agennix AGInvestor 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.comAdditional media contacts for Europe:MC Services AGPhone: +49 (0) 89 210 228 0Raimund Gabrielraimund.gabriel(at)mc-services.euHilda Juhaszhilda.juhasz(at)mc-services.euAdditional investor contact for Europe:Trout International LLCLauren (Rigg) Williams, Vice PresidentPhone: +44 207 936 9325lwilliams(at)troutgroup.com --- End of Message ---Agennix AGFraunhoferstr. 20 Martinsried GermanyISIN: DE000A1A6XX4; Listed: Regulierter Markt in Frankfurter Wertpapierbörse, Prime Standard in Frankfurter Wertpapierbörse;
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