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EANS-News: Agennix Announces New Data from Talactoferrin Phase II Trials in Non-Small Cell Lung Cancer and in Severe Sepsis Presented at ASCO Annual Meeting
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Research & Development
Planegg/Munich (Germany), Princeton, NJ and Houston, TX, (euro adhoc) - Agennix AG (Frankfurt Stock Exchange: AGX) announced that new data from Phase II trials in non-small cell lung cancer and in severe sepsis demonstrating the activity and tolerability of talactoferrin, an oral immunotherapy with antibacterial properties, were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.
Talactoferrin appears to improve survival in various prognostic subsets in Phase II trial in 2nd-line+ non-small cell lung cancer
Data from the Company´s Phase II trial evaluating talactoferrin plus best supportive care compared to placebo plus best supportive care in 2nd-line+ non-small cell lung cancer (NSCLC) were presented as a poster, "The effect of talactoferrin on overall survival in prognostically important NSCLC subsets in a randomized, placebo-controlled Phase II trial" (abstract #7569). The effect of talactoferrin on overall survival in this study was seen in a number of prognostically important patient subsets, including squamous and non-squamous histologies (tissue types). As previously disclosed, the trial met its primary endpoint, showing a 65% increase in median overall survival in the talactoferrin arm compared to control (6.1 months for talactoferrin versus 3.7 months for placebo; hazard ratio 0.68, one-tailed p-value <0.05).
Rajesh Malik, M.D., Chief Medical Officer of Agennix, said: "Treatment options for non-small cell lung cancer patients with refractory disease are often limited by, amongst other things, the histology of their disease, age or the patient´s ability to handle the toxic side effects of systemic therapy. The data from this study, although preliminary, suggest that talactoferrin has activity in various prognostically important subsets. Talactoferrin was also shown to be very well tolerated, which could provide a significant advantage for these sick patients, if the safety profile is reproduced in our ongoing Phase III study."
Dr. Malik continued: "The promising activity and safety data from this Phase II trial served as the basis for our ongoing Phase III FORTIS-M trial in advanced non-small cell lung cancer, which completed enrollment earlier this year. We anticipate top-line results from the FORTIS-M trial in the first half of 2012."
Overall survival data from a variety of patient subsets were presented in the poster at ASCO:
Group Subgroup N Hazard Ratio (90% Confidence Interval) ITT (overall population) 100 0.68 (0.47, 0.98) Histology Non-squamous 79 0.70 (0.45, 1.07) Squamous 21 0.43 (0.16, 1.13) Gender Male 66 0.62 (0.39, 0.99) Female 34 0.97 (0.51, 1.83) Age Group < or = 65 yr 75 0.70 (0.45, 1.08) >65 25 0.54 (0.25, 1.18) Disease Stage IIIB 25 0.61 (0.30, 1.22) IV 75 0.68 (0.44, 1.06) Line of Therapy 2nd 75 0.71 (0.46,1.10) > or = 3rd 25 0.58 (0.26, 1.28) ECOG PS 0 23 0.54 (0.24, 1.18) 1 77 0.70 (0.46, 1.08)
Talactoferrin was shown to be very well tolerated in this study, with fewer adverse events compared to placebo. The most frequently reported severe adverse event was dyspnea (labored breathing), which occurred in 15% of patients in the talactoferrin arm and 26% in the control arm. There were no serious adverse events considered to be related to treatment with talactoferrin.
Enrollment has completed in the Company´s ongoing Phase III FORTIS-M trial evaluating talactoferrin plus best supportive care compared to placebo plus best supportive care in NSCLC patients whose disease has progressed following two or more prior treatment regimens. Topline results are expected in the first half of 2012.
Talactoferrin reduces mortality in severe sepsis patients with different types of infections
Data from a randomized Phase II study that evaluated 190 patients with severe sepsis who received talactoferrin or placebo were presented in a poster discussion session, "Consistent mortality reduction by talactoferrin alfa (TLF) in severe sepsis with different types of infections" (abstract #9024). As previously reported, the study met the primary endpoint of reducing 28-day all-cause mortality. Talactoferrin was shown to have an effect across different sites and types of infection.
Jeffrey Crawford, M.D., Chief, Division of Medical Oncology, Duke University School of Medicine, said: "Talactoferrin appears to reduce mortality in severe sepsis patients while being well tolerated in this very sick patient population. A Phase II/III trial is planned in patients with severe sepsis. This could have important implications for subsequent studies in cancer patients, who are particularly susceptible to developing sepsis as their immune systems are often depressed by the treatments they receive, in addition to an increased risk of infection due to frequent hospitalization, surgeries and weakness due to illness. Thus it is important to the cancer care community that effective treatments be found for this condition."
In the talactoferrin Phase II trial in severe sepsis, the most common sites of infection were the lungs and blood. There was a consistent mortality decrease in the talactoferrin arm by sites of infection with the exception of intra-abdominal infection. A consistent reduction in mortality also occurred in patients with different types of infections, such as those caused by a single organism (e.g., a bacterium or fungus) or multiple organisms.
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.
Talactoferrin was very well tolerated in the study with no significant differences between the two treatment arms in frequency or severity of adverse events. 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 the second quarter of 2011.
About talactoferrin Talactoferrin is an oral immunotherapy with antibacterial properties, which is being studied for the treatment of cancer and severe sepsis. Talactoferrin has demonstrated promising activity in randomized, double-blind, placebo-controlled Phase II studies in NSCLC and in severe sepsis. Two Phase III trials with talactoferrin in NSCLC are ongoing. The FORTIS-M trial, which completed enrollment in March 2011, is evaluating talactoferrin in NSCLC patients whose disease has progressed following two or more prior treatment regimens. A second Phase III trial - FORTIS-C - is evaluating talactoferrin in combination with the standard chemotherapy regimen, carboplatin/paclitaxel, in first-line NSCLC patients. NSCLC is one of the most common types of cancer worldwide and the most frequent cause of cancer death. Agennix is also continuing the development of talactoferrin for the treatment of severe sepsis and plans to initiate a Phase II/III trial in that indication. 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 immunotherapy that has demonstrated activity in randomized, double-blind, placebo-controlled Phase II studies in non-small cell lung cancer and in severe sepsis. Talactoferrin is currently in Phase III clinical trials in non-small cell lung cancer, and Agennix is also continuing the development of this program for the treatment of severe sepsis. Other clinical development programs include RGB-286638, a multi-targeted kinase inhibitor in Phase I 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. 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. There can be no guarantee that the Company will move talactoferrin forward in development for severe sepsis in a timely manner, if at all. Even if the results from our later stage trials with talactoferrin, including the ongoing FORTIS-M trial in non-small cell lung cancer, are considered positive, they may not be sufficient to gain marketing approval in the United States or any other country, and the regulatory authorities may require additional information, data and/or further pre-clinical or clinical studies to support approval. In such event, there can be no guarantee that the Company will have or be able to obtain the financial resources to conduct any such additional studies or that such studies will yield results sufficient for approval. 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.
Agennix is a trademark of the Agennix group.
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