SOURCE: Agennix AG

Agennix AG

May 17, 2010 09:22 ET

Agennix AG Announces Presentation of New Data From Talactoferrin Randomized, Double-Blind, Placebo-Controlled Phase II Trial in Severe Sepsis at American Thoracic Society International Conference

Results Show Talactoferrin Reduces 28-Day All-Cause Mortality Across Wide Range of Baseline Prognostic Factors, Including APACHE II Score; Results Show No Significant Differences in Adverse Events for Talactoferrin Compared to Placebo

MARTINSRIED, GERMANY and PRINCETON, NJ and HOUSTON, TX--(Marketwire - May 17, 2010) -  Agennix AG (FRANKFURT: AGX) (XETRA: AGX) today announced the presentation of promising new activity and safety data from a Phase II trial with talactoferrin in severe sepsis at the International Conference of the American Thoracic Society in New Orleans, Louisiana. 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. Patients in both arms also received standard of care treatment for severe sepsis in an intensive care unit (ICU) setting. The data presented today show that talactoferrin reduced 28-day all-cause mortality in the overall population by 12% compared to placebo (45% relative reduction) and appeared to show an effect across a broad range of baseline characteristics, including APACHE II score, cardiovascular dysfunction and the number and type of organ dysfunctions, all of which are important prognostic factors for severe sepsis. The results showed that talactoferrin also reduced all-cause mortality compared to placebo over the longer term -- at three months and at six months.

Kalpalatha Guntupalli, M.D., Professor and Chief, Pulmonary Critical Care and Sleep Medicine, Baylor College of Medicine and principal investigator of the talactoferrin Phase II trial, said: "There are currently limited treatment options for patients with severe sepsis, a condition that is very challenging to treat and for which the mortality rate is approximately 30-40%. This study demonstrates that talactoferrin has the potential to have a major impact on reducing mortality in patients with severe sepsis and that this improvement appears to be consistent regardless of APACHE II baseline score. Talactoferrin was also shown to be well tolerated in this very sick patient population."

Rajesh Malik, M.D., Chief Medical Officer of Agennix AG, said: "We are very excited about the data presented today from our Phase II trial with talactoferrin in severe sepsis. Once we have met with regulatory authorities to discuss these data and our plans, we look forward to advancing the development of talactoferrin for this indication." 

The Phase II trial achieved its primary endpoint of a reduction in 28-day all-cause mortality from 26.6% in the placebo arm to 14.6% in the talactoferrin arm (two-tailed unadjusted p-value = 0.04, odds ratio by logistic regression analysis = 0.47), as previously disclosed. Patients were stratified by clinical site and by the presence or absence of cardiovascular dysfunction due to sepsis. When the trial results were adjusted for cardiovascular dysfunction, the two-tailed p-value was 0.06, and the odds ratio was 0.49. 

Sixty-four percent (64%) of patients (n=121) in the trial had cardiovascular dysfunction due to sepsis and 36% (n=69) did not at baseline. For those patients with cardiovascular dysfunction, talactoferrin showed a relative reduction in 28-day all-cause mortality of 22% (28.6% for the placebo arm versus 22.4% for the talactoferrin arm). For patients who did not have cardiovascular dysfunction, talactoferrin showed a relative reduction in 28-day all-cause mortality of 88% (22.6% for placebo vs. 2.6% in the talactoferrin arm). 

Talactoferrin showed a trend toward a decrease in 28-day all-cause mortality across all baseline APACHE II score quartiles. In patients with APACHE II scores of 0-18, talactoferrin reduced mortality by 56% (8.7% for placebo vs. 3.8% for talactoferrin); in patients with APACHE II scores of 19-23, talactoferrin reduced mortality by 44% (13.8% for placebo vs. 7.7% for talactoferrin); in patients with APACHE II scores between 24-27, talactoferrin reduced mortality by 50% (33.3% for placebo vs. 16.7% for talactoferrin) and in patients with scores greater than 27, the sickest patient group, mortality was reduced by 42% (60% for placebo vs. 35% for talactoferrin). 

In addition, talactoferrin reduced mortality in patients with different numbers and types of organ dysfunctions at baseline. For patients with three or less organ dysfunctions at baseline (89% of enrolled patients), there was a statistically significant 53% reduction in mortality from 24.4% for placebo versus 11.4% for talactoferrin (two-tailed p-value by Fisher's Exact test = 0.03).

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 (5.6% of patients in the talactoferrin arm and 5.3% in the placebo arm). There were no serious adverse events considered to be related to treatment with talactoferrin. 

The above analyses were all conducted on a modified intent-to-treat basis (also referred to as intent-to-treat as treated), meaning that patients were evaluated based on the treatment they actually received (talactoferrin or placebo) during the first week of treatment. The median number of treatment days was 6.0 for the talactoferrin group and 4.5 days for placebo.

All patients were centrally screened for eligibility prior to randomization. The arms were generally well balanced in terms of baseline characteristics. 

The Phase II trial was primarily funded by a $3 million grant from the U.S. National Institutes of Health.

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 30-40% 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 studies 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 traded biopharmaceutical company that is focused on the development of novel therapies to improve the length and quality of life of seriously 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: 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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