EANS-News: AGENNIX AG
Agennix AG Announces Data from Talactoferrin Randomized,
Double-Blind, Placebo-Controlled Phase II Trial in Severe Sepsis Presented at
the Sepsis 2010 International Symposium
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Research & Development/Severe Sepsis
Heidelberg (euro adhoc) - Planegg/Munich (Germany), Princeton, NJ and Houston, TX, September 3, 2010 - Agennix AG (Frankfurt Stock Exchange: AGX) announced that data from a Phase II trial with talactoferrin in severe sepsis were presented today at the Sepsis 2010 International Symposium, which was hosted by the International Sepsis Forum, in Paris, France. The double-blind, placebo-controlled trial evaluated talactoferrin versus placebo in 190 adult patients with severe sepsis enrolled at 25 leading centers across the U.S. As previously reported, the Phase II trial achieved its primary endpoint of a reduction in 28-day all-cause mortality from 26.9% in the placebo arm to 14.4% in the talactoferrin arm (two-tailed p-value adjusted for cardiovascular dysfunction = 0.05, odds ratio by logistic regression analysis = 0.48), a 46% relative reduction (12.5% absolute reduction).
Steven Opal, M.D., Professor of Medicine, Infectious Disease Division, Alpert Medical School, Brown University, Providence, Rhode Island, presented the data. Dr. Opal said: "There is an urgent need for more effective treatment options for patients with severe sepsis, a challenging to treat condition that affects over 750,000 people in the U.S. annually and a similar number in Europe. The results of this Phase II trial indicate that talactoferrin has the potential to reduce mortality in patients with severe sepsis while being well tolerated in this very sick patient population. These results warrant additional study of talactoferrin to treat this condition."
The Phase II trial was primarily funded by a $3 million grant from the U.S. National Institutes of Health.
Agennix plans to start an initial Phase III trial with talactoferrin in severe sepsis in early 2011.
About severe sepsis Sepsis is a condition involving infection and generalized inflammation. The body´s normal response to an infection is to set off a limited chain reaction to fight the infection. In severe sepsis, this systemic immune response becomes overactive and results in damage to vital body organs, leading to a shutdown of one or more organs and, in many cases, death. Each year, approximately 750,000 people in the U.S. develop severe sepsis, and a similar number of people are affected in Europe. Due to the aging of the population, this number is expected to grow over time. An estimated 30-35% of people with severe sepsis are expected to die annually from this condition in the U.S., and the U.S. Centers for Disease Control and Prevention indicates that sepsis is one of the top ten leading causes of death in the U.S. Patients suffering from severe sepsis must be hospitalized, often in an intensive care unit, and the medical costs to treat sepsis were estimated in 2001 to be over $16 billion in the U.S. alone, a number that is believed to have increased significantly over time.
About talactoferrin Talactoferrin is an oral biologic therapy with immunomodulatory and antibacterial properties, which is being studied for the treatment of cancer and severe sepsis. Talactoferrin has demonstrated activity in randomized, double-blind, placebo-controlled Phase II studies in non-small cell lung cancer (NSCLC), as well as in severe sepsis. As a result of the promising results from Phase II studies, two Phase III trials with talactoferrin in NSCLC have been initiated. NSCLC is one of the most common types of cancer worldwide and the most frequent cause of cancer death. Agennix also plans to develop talactoferrin further for the treatment of severe sepsis. Talactoferrin has been shown to be very well tolerated in these patient populations.
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 improve the length and quality of life of critically ill patients in areas of major unmet medical need. The Company´s most advanced program is talactoferrin, an oral therapy that has demonstrated activity in randomized, double-blind, placebo-controlled Phase II studies in non-small cell lung cancer, as well as in severe sepsis. Talactoferrin is currently in Phase III clinical trials in non-small cell lung cancer, and Agennix plans to develop this program further for the treatment of severe sepsis. Other clinical development programs include RGB-286638, a multi-targeted kinase inhibitor in Phase 1 testing; the oral platinum-based compound satraplatin; 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 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 the results, performance or achievements expressed or implied by such forward-looking statements. There can be no guarantee that the Company will move talactoferrin forward in development for severe sepsis in a timely manner, if at all, or that talactoferrin will ultimately be approved for sale in any country. 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. 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.
end of announcement euro adhoc --------------------------------------------------------------------------------
Further inquiry note:
Agennix AG
Investor Relations & Corporate Communications
Phone: +49 (0)89 8565 2693
ir@agennix.com
In the U.S.: Laurie Doyle
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 for Europe:
Trout International LLC
Lauren Williams, Vice President
Phone: +44 207 936 9325
lwilliams@troutgroup.com
Branche: Pharmaceuticals
ISIN: DE000A1A6XX4
WKN: A1A6XX
Index: CDAX, Prime All Share, Technology All Share
Börsen: Frankfurt / regulated dealing/prime standard
Berlin / free trade
Hamburg / free trade
Düsseldorf / free trade
Hannover / free trade
München / free trade
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