17.01.2011 – 10:03
EANS-News: AGENNIX AG
Agennix AG Announces Longer-Term Mortality Data from
Talactoferrin Phase II Trial in Severe Sepsis Presented
at 40th Critical Care Congress
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Research & Development/Clinical Data - Sepsis
Heidelberg (euro adhoc) - Planegg/Munich (Germany), Princeton, NJ and Houston, TX, January 17, 2011 - Agennix AG (Frankfurt Stock Exchange: AGX) announced that new and more detailed data from a Phase II trial in severe sepsis with talactoferrin, an oral biologic therapy with immunomodulatory and antibacterial properties, were presented at the 40th Critical Care Congress of the Society of Critical Care Medicine in San Diego, California. 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 (13% absolute reduction). The presentation reported that the effect of talactoferrin on reduction in all-cause mortality was sustained at three and six months. The reduction in mortality was seen in patients with and without cardiovascular dysfunction. However, there appeared to be a greater, significant effect in patients without cardiovascular dysfunction, which is consistent with the effect seen on 28-day mortality.
Mitchell M. Levy, M.D., Professor of Medicine at Brown Medical School and Medical Director of the Medical Intensive Care Unit at Rhode Island Hospital, Providence, Rhode Island, presented the data. Dr. Levy said: "There is an urgent need for more effective treatment options for patients with severe sepsis, which affects over 750,000 patients annually in the U.S. alone. The results of this Phase II trial indicate that talactoferrin has the potential to reduce mortality in patients with severe sepsis while being very well tolerated and that the results are sustained over time to at least six months. These results warrant additional study of talactoferrin to treat this serious condition."
The following results were reported: Three-month all-cause mortality was 29.7% in the placebo arm compared to 17.9% in the talactoferrin arm, an absolute reduction of 12% (two-tailed p-value adjusted for cardiovascular dysfunction = 0.09). For patients with cardiovascular dysfunction, there was an absolute reduction of 7% in three-month all-cause mortality with 32.8% in the placebo arm compared to 26.3% in the talactoferrin arm. For patients without cardiovascular dysfunction, there was an absolute reduction of 18% with 23.3% in the placebo group and 5.3% in the talactoferrin group.
At six months, there was a statistically significant reduction in all-cause mortality from 35.6% in the placebo arm to 21.1% in the talactoferrin arm, an absolute reduction of 15% (p-value = 0.04). For patients with cardiovascular dysfunction, there was an absolute reduction of 10% in six-month all cause mortality with 38.3% in the placebo arm compared to 28.1% in the talactoferrin arm. For patients without cardiovascular dysfunction, there was an absolute reduction in six-month all cause mortality of 20% with 30.0% in the placebo group and 10.5% in the talactoferrin group.
The above analyses were all conducted on a modified intent-to-treat (ITT) as treated basis, meaning that patients were evaluated based on the treatment they actually received (talactoferrin or placebo) during the first week on study. Three-month and six-month all-cause mortality were secondary endpoints in the trial.
Talactoferrin was very well tolerated in the study with no significant differences in adverse events between the two treatment arms. Of those adverse events considered to be possibly related to treatment, the most frequently reported category in both treatment groups was gastrointestinal disorders (5.5% of patients in the talactoferrin arm and 5.4% in the placebo arm). There were no serious adverse events considered to be related to treatment with talactoferrin.
The Phase II trial was primarily funded by a grant from the U.S. National Institutes of Health.
Agennix plans to initiate the Phase II portion of a Phase II/III trial with talactoferrin in severe sepsis in March or April 2011.
Echocardiogram assessment of cardiac function also presented In a poster entitled, "Talactoferrin may confer increased survival in patients with septic shock and systolic cardiac dysfunction," echocardiogram data from patients at four clinical sites in the Phase II trial with talactoferrin in severe sepsis were presented. Forty-six patients were enrolled at the sites and had an interpretable echocardiogram within 24 hours preceding or following randomization. Among the 33 patients with septic shock and abnormal systolic function (heart contraction), talactoferrin therapy may be associated with improved survival.
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. More than 30% of people with severe sepsis are estimated 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 and expects to initiate the Phase II portion of a Phase II/III trial in that indication in March/April 2011. 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; 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 indication 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.
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