05.08.2010 – 08:37
EANS-News: AGENNIX AG /
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Research & Development
Heidelberg (euro adhoc) - Agennix AG Provides Update on Development of Talactoferrin Planegg/Munich (Germany), Princeton, NJ and Houston, TX, August 5, 2010 -
Agennix AG (Frankfurt Stock Exchange: AGX) today provided an update on its development status and plans for oral talactoferrin.
Enrollment on track in Phase III FORTIS-M trial in non-small cell lung cancer The Company reported that, as of July 31, 2010, 45% of patients (327) in the FORTIS-M trial had been enrolled. The total planned enrollment in the study is 720 patients. FORTIS-M is evaluating talactoferrin plus best supportive care compared to placebo plus best supportive care in patients with non-small cell lung cancer, whose disease has progressed following two or more prior treatment regimens. The trial remains on track with enrollment expected to complete in the first half of 2011 and topline data expected by the end of 2011, should all proceed as anticipated.
Phase III registration plan in severe sepsis The Company also reported that it has held an End-of-Phase II meeting with the U.S. Food & Drug Administration (FDA) to discuss future development plans for talactoferrin in severe sepsis. The Company plans to meet with European regulatory authorities within the next few months to discuss its development plans in this indication. In its discussions with the Company, the FDA strongly recommended that Agennix conduct two adequate and well-controlled Phase III studies to support a potential Biologic License Application (BLA) submission.
Agennix plans to start an initial randomized, double-blind, placebo-controlled Phase III trial evaluating oral talactoferrin in adult patients with severe sepsis (sepsis plus one or more organ dysfunctions) in early 2011. In order to maximize the chances of success, the Company intends to base the design of this initial Phase III trial closely on the randomized, double-blind, placebo- controlled Phase II trial, the topline results of which were announced in December 2009. In the Phase III trial, the Company plans to accrue approximately 930 adult patients with severe sepsis at 100-150 leading sites worldwide for the treatment of sepsis. Similar to the Phase II trial, all potentially eligible patients for the Phase III trial will be centrally screened prior to enrollment to confirm that they meet the eligibility criteria. Patients will be randomized to receive oral talactoferrin or placebo. Patients in both arms will also receive standard of care treatment for severe sepsis in an intensive care unit (ICU) setting. The primary endpoint of the Phase III trial will be 28-day all-cause mortality, with secondary endpoints to include longer-term survival. The FDA has confirmed that the proposed primary endpoint is acceptable and indicated that secondary endpoints should include assessment of mortality at 3, 6 and 12 months.
Rajesh Malik, M.D., Chief Medical Officer of Agennix, said, "We are excited to advance the development of talactoferrin in severe sepsis. This is a life- threatening condition that, with an estimated mortality rate of 30% or higher, is urgently in need of new, effective therapies. We look forward to initiating a Phase III trial in early 2011 in this important indication."
Data update from Phase II trial in severe sepsis The Company also reported that, as part of an independent final audit of the Phase II trial with talactoferrin in severe sepsis prior to preparing for publication of the results, it was determined that one additional patient was affected by the previously disclosed drug labeling and randomization error. The identified patient had mistakenly been included in the placebo arm and should have been included in the talactoferrin arm. Thus, there were 97 patients in the talactoferrin arm and 93 patients in the placebo arm (previously reported as 96 patients in the talactoferrin arm and 94 in the placebo arm). This change did not have a material effect on the outcome of the trial. Baseline characteristics of patients entering the study were mostly balanced between the talactoferrin and placebo groups.
The final primary endpoint results are now as follows: 46% relative reduction (13% absolute 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). These results reflect a slightly larger improvement in mortality in the talactoferrin arm when compared to the placebo arm than earlier reported. Talactoferrin continued to appear to show an effect over the longer term, at three and six months. These results reflect a slightly larger improvement in three- and six-month mortality in the talactoferrin arm when compared to the placebo arm than earlier 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% and relative reduction of 40% (adjusted two-tailed p-value = 0.08, odds ratio = 0.54). 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% and relative reduction of 41% (adjusted two-tailed p-value = 0.04, odds ratio = 0.50).
Talactoferrin continued to appear to show a substantial trend toward a decrease in 28-day all-cause mortality in the upper two baseline APACHE II score (an assessment of the severity of the condition) quartiles, with a slight decrease in the second quartile and a slight increase in patients in the lowest APACHE II quartile (scores 0-19), i.e., the least sick patients. It should be noted, however, that, for each of the lower two quartiles, the difference was only one death between the arms. None of the differences was statistically significant. In addition, there appears to have been no effect on mortality in women in this trial, although it is unclear whether this outcome would be seen in a larger Phase III trial or whether it is merely a consequence of the relatively small number of patients in this trial.
The above analyses were 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 their first week of treatment.
Talactoferrin was shown to be 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 Company expects the final results from the trial to be submitted for publication in a peer-reviewed journal. 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.
-----------------------  Previously, the reported 28-day all-cause mortality results were as follows: 26.6% in the placebo group compared to 14.6% in the talactoferrin group, a 12% absolute and 45% relative reduction (two-tailed adjusted p-value = 0.06, odds ratio = 0.49).
 Previously, the reported three-month all-cause mortality was 29.3% in the placebo arm compared to 18.1% in the talactoferrin arm (adjusted two-tailed p- value = 0.09, odds ratio = 0.55).
 Previously, the reported six-month all-cause mortality was 35.2% in the placebo arm versus 21.3% in the talactoferrin arm (adjusted two-tailed p-value = 0.05, odds ratio = 0.51).
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