Agennix AG Announces Positive Results with Talactoferrin In
Randomized, Double-Blind, Placebo-Contro
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.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 tolerated- Conference call and webcast scheduled for Wednesday,December 2 at 9 AM ET/3 PM CETMartinsried/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)."We are very excited to see such compelling results withtalactoferrin in severe sepsis, a life-threatening and notoriouslyhard-to-treat disease," said Rajesh Malik, M.D., Chief MedicalOfficer. "There are currently very limited treatment optionsavailable, with only one drug in the U.S. approved specifically forsevere sepsis, a disease that results in hundreds of thousands ofdeaths each year in the U.S. and Europe alone. Given the strength ofthese clinical trial results, we plan to talk with regulatoryauthorities, as well as key opinion leaders and potential partners,about advancing talactoferrin for this indication."Patients were stratified by clinical site and by the presence orabsence of cardiovascular dysfunction. Cardiovascular dysfunction isa major prognostic factor for severe sepsis. A similar number ofpatients had cardiovascular dysfunction in the two treatment groups.Sixty-four percent (64%) of patients (n=121) in the trial hadcardiovascular dysfunction and 36% (n=69) did not. For thosepatients with cardiovascular dysfunction, 28-day all cause mortalitywas 28.6% for the placebo arm and 22.4% for the talactoferrin arm.For patients who did not have cardiovascular dysfunction, 28-day allcause mortality was 22.6% in the placebo arm compared to 2.6% in thetalactoferrin arm. When the trial results were adjusted forcardiovascular dysfunction, the two-tailed p-value was 0.06, and theodds ratio was 0.49.The above analyses were all conducted on an intent-to-treat (ITT), astreated basis, meaning that patients were evaluated based on thetreatment they actually received (talactoferrin or placebo). An ITTas treated analysis is a method to address patient assignment errorsin a way that mitigates the potential impact on the data analysis ofa trial. In this study, the quality control process identifiederrors in drug labeling and randomization during the conduct of thetrial that affected the drug assignment for some patients. That iswhy this analysis was used, following feedback from the U.S. Food andDrug Administration (FDA). To determine if the assignment error hadan impact on the outcome of the trial, as recommended by the FDA, theCompany conducted a sensitivity analysis evaluating 28-day all causemortality by excluding 22 patients who mistakenly received bothtalactoferrin and placebo. This analysis indicated that there was noapparent effect of the patient assignment errors on the outcome ofthe trial. The sensitivity analysis showed that 28-day all causemortality in the placebo arm was 25.9% compared to 15.1% for thetalactoferrin arm.Talactoferrin was shown to be very well tolerated in the study withno major differences in adverse events between the two treatmentarms.The study included 96 patients in the talactoferrin arm and 94patients in the placebo arm. In addition, four patients wererandomized but did not receive study drug due to withdrawal prior toreceiving the first dose. All patients were centrally screened foreligibility prior to randomization. The arms were well balanced interms of baseline characteristics.The Phase 2 trial was primarily funded by a grant from the U.S.National Institutes of Health.The Company plans to present data from the trial at an upcoming majormedical meeting.Conference 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 severe sepsisSepsis is a condition involving known or suspected infection andgeneralized inflammation. The body's normal response to an infectionis to set off a limited chain reaction to fight the infection. Insevere sepsis, this systemic response escalates into an overreactionby the body that leads to dysfunction of one or more organs. Eachyear, approximately 750,000 people in North America develop severesepsis, and a similar number of people are affected in Europe. Thosefigures are expected to rise due to the aging population and otherfactors. Approximately 30% of people with severe sepsis areestimated to die annually from this condition in the U.S., and theU.S. Centers for Disease Control and Prevention indicates that sepsisis one of the top ten leading causes of death in the U.S. Patientssuffering from severe sepsis must be hospitalized, often in anintensive care unit, and the medical costs to treat sepsis areestimated to be over $16 billion annually in the U.S. alone.About talactoferrinTalactoferrin is an oral novel targeted dendritic cell recruiter andactivator being studied mainly for the treatment of cancer.Talactoferrin has demonstrated anti-cancer activity in tworandomized, double-blind, placebo-controlled Phase 2 studies innon-small cell lung cancer (NSCLC). NSCLC is one of the most commontypes of cancer worldwide and the most frequent cause of cancerdeath. As a result of the promising results from Phase 2 studies, twoPhase 3 studies with talactoferrin in NSCLC have been initiated.Talactoferrin has also shown activity in renal cell carcinoma, aswell as severe sepsis. Talactoferrin has been shown to be very welltolerated in these patient populations. The Company also has atopical formulation of talactoferrin for wound healing.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 press release contains forward-looking statements, which expressthe current beliefs and expectations of the management of Agennix AG.Such statements are based on current expectations and are subject torisks and uncertainties, many of which are beyond our control, thatcould cause future results, performance or achievements to differsignificantly from the results, performance or achievements expressedor implied by such forward-looking statements. There can be noguarantee 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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Datum: 01.12.2009 - 17:33 Uhr
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