EANS-News: AGENNIX AG Reports Additional Talactoferrin Alfa Data
-------------------------------------------------------------------------------- Corporate news transmitted by euro adhoc. The issuer/originator is solely responsible for the content of this announcement. -------------------------------------------------------------------------------- Research & Development Planegg/Munich and Princeton, NJ (euro adhoc) - Agennix AG (Frankfurt Stock Exchange: AGX) today announced results from several clinical studies evaluating talactoferrin alfa (talactoferrin). FORTIS-C Phase III trial with talactoferrin in first-line non-small cell lung cancer closed early and unblinded; top-line results announced As previously announced, following the negative results of the FORTIS-M Phase III trial evaluating talactoferrin in non-small cell lung cancer (NSCLC) patients whose disease had progressed following two or more prior treatment regimens, Agennix made the decision to stop enrollment and analyze the results from the FORTIS-C Phase III trial. This trial evaluated talactoferrin in combination with a standard chemotherapy regimen, carboplatin plus paclitaxel, compared to placebo plus carboplatin and paclitaxel in first-line NSCLC patients with advanced or metastatic disease (patients who have not yet been treated for their disease). At the time the FORTIS-C trial was stopped, 94 of the planned 1,100 patients had been enrolled and received study drug; all patients were enrolled at five U.S. sites. The study had co-primary endpoints of progression-free survival (PFS) and overall survival (OS). Investigator-reported median PFS in the talactoferrin arm was 5.8 months compared to 5.6 months for placebo(hazard ratio 0.97, p-value 0.89). Median OS in the talactoferrin arm was 11.4 months compared to 12.7 months for placebo (hazard ratio 1.25, p-value 0.36). The nature and incidence of adverse events in the talactoferrin arm were similar to that of placebo. Final data reported in Phase I/II study evaluating talactoferrin's potential to prevent nosocomial infections in pre-term infants The Company also reported final data from a Phase I/II randomized, placebo- controlled trial, funded by a U.S. National Institutes of Health (NIH) grant, evaluating talactoferrin's potential to reduce the incidence of nosocomial (hospital acquired) infections in infants born prematurely, which was the primary endpoint. The study enrolled a total of 120 patients. Ten percent of patients (6 of 60) in the talactoferrin arm developed nosocomial infections compared to fifteen percent (9 of 60) in the placebo arm. This difference, while in favor of talactoferrin, was not statistically significant. The nature and incidence of adverse events in the talactoferrin arm were generally similar to that of placebo and consistent with expectations for the population under study. Final data from halted OASIS Phase II/III trial in severe sepsis presented at ISF Sepsis 2012 Final data from the halted OASIS Phase II/III trial evaluating talactoferrin in adult patients with severe sepsis were presented in November at the International Sepsis Forum Sepsis 2012 meeting. Data presented included 28-day and three-month all-cause mortality. As previously reported, talactoferrin did not improve 28-day all-cause mortality, the primary endpoint of the study, nor did it improve mortality at three months. The most commonly reported adverse events in the study were in line with those that generally occur with sepsis patients in the intensive care unit and were generally similar between placebo and talactoferrin. Rajesh Malik, M.D., Chief Medical Officer, said: "We have performed extensive analyses of the talactoferrin program to determine if there is a potential explanation for the outcomes of recent clinical trials compared to earlier promising results. If the hypotheses generated from these analyses can be confirmed by additional research, a new development path forward for talactoferrin may be considered. We will further update the market as soon as we are in a position to do so." 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 clinical development programs include oral talactoferrin alfa; a topical gel form of talactoferrin and RGB-286638, a multi-targeted kinase inhibitor. Agennix's registered seat is in Heidelberg, Germany. The Company has two sites of operation: Planegg/Munich, Germany and Princeton, New Jersey. For additional information, please visit the Agennix Web site at www.agennix.com. This press release 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 press release. The achievement of positive results in early stage clinical studies does not ensure that later stage 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 its product candidates or that it will be successful in pursuing a strategic transaction. 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: Agennix AG 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 end of announcement euro adhoc -------------------------------------------------------------------------------- company: 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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