SOURCE: Agennix AG

Agennix AG

February 26, 2010 02:40 ET

Agennix AG Announces Longer-Term Mortality Results From Talactoferrin Phase 2 Trial in Severe Sepsis

Trial Results Show Effect of Talactoferrin on Reduction in Mortality Is Sustained at Three Months and Six Months

MARTINSRIED/MUNICH, GERMANY and PRINCETON, NJ and HOUSTON, TX--(Marketwire - February 26, 2010) -  Agennix AG (FRANKFURT: AGX) (XETRA: AGX) today announced longer-term mortality results from the talactoferrin randomized, double-blind, placebo-controlled Phase 2 trial in severe sepsis. The trial evaluated talactoferrin versus placebo in 190 adult patients with severe sepsis enrolled at 25 leading centers across the U.S. Patients in both arms received standard of care treatment for severe sepsis in an intensive care unit (ICU) setting. As previously reported, the trial achieved its primary endpoint of a reduction in 28-day all-cause mortality. The results announced today showed that talactoferrin also reduced all-cause mortality compared to placebo over the longer term -- at three months and at six months.

Three-month all-cause mortality was 29.3% in the placebo arm compared to 18.1% in the talactoferrin arm, an absolute reduction of 11% and relative reduction of 38% (unadjusted two-tailed p-value = 0.07, odds ratio by logistic regression analysis = 0.53). When the results were adjusted for cardiovascular dysfunction, a major prognostic factor for severe sepsis, the two-tailed p-value was 0.09, and the odds ratio was 0.55.

At six months, there was a statistically significant reduction in all-cause mortality from 35.2% in the placebo arm to 21.3% in the talactoferrin arm, an absolute reduction of 14% and relative reduction of 39% (unadjusted two-tailed p-value = 0.04, odds ratio = 0.50; adjusted two-tailed p-value = 0.05, odds ratio = 0.51). The absolute reduction in six-month all-cause mortality of 14% was greater than the absolute reduction seen in 28-day all-cause mortality (which was 12%, from 26.6% in the placebo arm to 14.6% in the talactoferrin arm).

The results for three- and six-month all-cause mortality in the study were consistent and sustained for patients with and without cardiovascular dysfunction.

"We are extremely pleased to see that the treatment effect of talactoferrin in severe sepsis appears to be sustained over a longer time period," said Rajesh Malik, M.D., Chief Medical Officer. "There are currently very limited treatment options available, with only one drug approved specifically for severe sepsis, a disease that results in hundreds of thousands of deaths each year in the U.S. and Europe alone. We plan to meet with regulatory authorities within the next few months to discuss plans for advancing talactoferrin for this indication."

The above analyses were all conducted on an intent-to-treat (ITT) as-treated basis, meaning that patients were evaluated based on the treatment they actually received (talactoferrin or placebo).

Talactoferrin was shown to be very well tolerated in the study with no major differences in adverse events between the two treatment arms.

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 major medical meeting.

About severe sepsis
Sepsis is a condition involving known or suspected 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 response escalates into an overreaction by the body that leads to dysfunction of one or more organs. Each year, approximately 750,000 people in the U.S. alone develop severe sepsis, and a similar number of people are affected in Europe. Those figures are expected to rise due to the aging population and other factors. Approximately 30-40% 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.

About oral talactoferrin
Talactoferrin is an oral novel targeted dendritic cell recruiter and activator being studied mainly for the treatment of cancer and severe sepsis. Talactoferrin has demonstrated activity in randomized, double-blind, placebo-controlled Phase 2 studies in non-small cell lung cancer (NSCLC) as well as in severe sepsis. As a result of the promising results from Phase 2 NSCLC studies, two Phase 3 studies have been initiated with talactoferrin in NSCLC. The Company is planning to meet with regulatory authorities to discuss a plan for the further development of talactoferrin 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 traded biopharmaceutical company that is developing novel therapies in areas of major unmet medical need to improve the length and quality of life of seriously ill patients. The Company's most advanced program is talactoferrin, an oral targeted therapy that has demonstrated activity in randomized, double-blind, placebo-controlled Phase 2 studies in non-small cell lung cancer as well as in severe sepsis. Talactoferrin is currently in Phase 3 clinical trials in non-small cell lung cancer. 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: Martinsried/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.

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