EANS-Adhoc: Agennix Reports Results of FORTIS-M Phase III Trial with Talactoferrin Alfa in Non-small Cell Lung Cancer
-------------------------------------------------------------------------------- ad-hoc disclosure pursuant to section 15 of the WpHG transmitted by euro adhoc with the aim of a Europe-wide distribution. The issuer is solely responsible for the content of this announcement. -------------------------------------------------------------------------------- Research & Development/Phase III study results 06.08.2012 - TRIAL DOES NOT ACHIEVE PRIMARY ENDPOINT - COMPANY TO HOLD CONFERENCE CALL TUESDAY, AUGUST 7TH AT 2 PM CET/8 AM EDT Planegg/Munich (Germany), Princeton, NJ and Houston, TX, August 6, 2012 - Agennix AG (Frankfurt Stock Exchange: AGX) today announced that the FORTIS-M Phase III trial with talactoferrin alfa (talactoferrin) did not meet its primary endpoint of improving overall survival. The FORTIS-M trial evaluated talactoferrin plus best supportive care compared to placebo plus best supportive care in patients with non-small cell lung cancer (NSCLC) whose disease had progressed following two or more prior treatment regimens. Median overall survival in the talactoferrin arm was 7.5 months compared to 7.7 months for placebo (hazard ratio 1.04, p-value 0.66). The nature and incidence of adverse events in the talactoferrin arm were similar to that of placebo and consistent with previous clinical trials. Agennix is taking immediate steps to conserve cash while it evaluates its business options and will provide more details on its corporate plans in the near future. END OF AD HOC ANNOUNCEMENT Conference Call Scheduled Agennix has scheduled a conference call, which will be conducted in English, to be held on Tuesday, August 7, 2012 at 8 AM EDT/2 PM CET. A live webcast will be available on the Agennix Web site at www.agennix.com. A replay will be available via the Web site following the live event. Dial-in numbers for the call are as follows: Participants from Europe: 0049 (0)69 7104 45598 0044 (0)20 3003 2666 Participants from the U.S.: 1 212 999 6659 Please dial in 10 minutes before the beginning of the conference call. About Agennix Agennix AG is a publicly listed biopharmaceutical company that is focused on the development of novel therapies that have the potential to substantially lengthen and improve the lives of critically ill patients in areas of major unmet medical need. The Company's most advanced investigational agent is talactoferrin alfa, a first-in-class oral Dendritic Cell Mediated Immunotherapy (DCMI). Talactoferrin alfa is currently being studied for the treatment of non-small cell lung cancer. Other clinical development programs include RGB-286638, a multi-targeted kinase inhibitor in Phase I testing for cancer, and a topical gel form of talactoferrin for diabetic foot ulcers. Agennix's registered seat is in Heidelberg, Germany. The Company has three sites of operation: Planegg/Munich, Germany; Princeton, New Jersey and Houston, Texas. For additional information, please visit the Agennix Web site at www.agennix.com. This adhoc announcement contains forward-looking statements, which express the current beliefs and expectations of the management of Agennix AG. Such statements are based on current expectations and are subject to risks and uncertainties, many of which are beyond our control, that could cause future results, performance or achievements to differ significantly from those expressed or implied by such forward-looking statements. Actual results could differ materially depending on a number of factors, and we caution investors not to place undue reliance on the forward-looking statements contained in this ad hoc announcement. The achievement of positive results in early stage clinical studies does not ensure that later stage or large scale clinical studies will be successful. There can be no guarantee that the Company will have or be able to obtain the financial resources to conduct additional studies with talactoferrin alfa or other product candidates or that such studies will yield results sufficient for approval. There can be no guarantee that the Company will be able to partner talactoferrin alfa or obtain additional financial resources. Forward-looking statements speak only as of the date on which they are made and Agennix undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future. Agennix® is a trademark of Agennix AG. Further inquiry note: Barbara Mueller Manager, Investor Relations & Corporate Communications Phone: +49 (0)89 8565 2693 ir@agennix.com In the U.S.: Laurie Doyle Senior Director, Investor Relations & Corporate Communications Phone: +1 609 524 5884 laurie.doyle@agennix.com Additional media contact for Europe: MC Services AG Raimund Gabriel Phone: +49 (0) 89 210 228 0 raimund.gabriel@mc-services.eu Additional investor contact: Trout International LLC Lauren Williams, Senior Vice President Phone: +44 207 936 9325 lwilliams@troutgroup.com end of announcement euro adhoc -------------------------------------------------------------------------------- issuer: AGENNIX AG Im Neuenheimer Feld 515 D-69120 Heidelberg phone: +49 89 8565 2693 FAX: +49 89 8565 2610 mail: ir@agennix.com WWW: http://www.agennix.com sector: Pharmaceuticals ISIN: DE000A1A6XX4 indexes: CDAX, Prime All Share, Technology All Share stockmarkets: free trade: Hannover, Berlin, München, Hamburg, Düsseldorf, regulated dealing/prime standard: Frankfurt language: English
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