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Research & Development
Planegg/Munich (Germany), Princeton, NJ and Houston, TX (euro adhoc) - Agennix AG (Frankfurt Stock Exchange: AGX) has announced the publication of a Phase II randomized, double-blind, placebo-controlled clinical trial evaluating the Company's lead product candidate, oral talactoferrin, in first-line non-small cell lung cancer (NSCLC) in the peer-reviewed medical journal, Journal of Thoracic Oncology. The publication, "A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Oral Talactoferrin in Combination with Carboplatin and Paclitaxel in Previously Untreated Locally Advanced or Metastatic Non-small Cell Lung Cancer" by R. Digumarti et al, appears in the June 2011 issue of the journal. As previously reported, this study achieved its primary endpoint of improvement in confirmed response rate in the evaluable population. Supportive results were seen in the secondary endpoints of progression-free survival and overall survival. Talactoferrin appeared to be well tolerated with a statistically significant decrease in adverse events compared to placebo.
"The results from this study show the potential activity, as well as good tolerability, of talactoferrin in this clinical setting," said Rajesh Malik, M.D., Chief Medical Officer. "These data provide support for the ongoing Phase III development program with talactoferrin in non-small cell lung cancer. Our Phase III trial, FORTIS-M, evaluating talactoferrin in non-small cell lung cancer patients whose disease has progressed following two or more prior treatment regimens, completed enrollment earlier this year, and we expect top-line results from that study in the first half of 2012."
The published Phase II trial involved 110 randomized patients with previously untreated stage IIIB/IV non-small cell lung cancer and evaluated the use of talactoferrin in combination with the standard chemotherapy regimen, carboplatin plus paclitaxel, compared to placebo plus the same chemotherapy treatment. The results showed that talactoferrin increased the confirmed response rate compared to placebo. The response rate in the 100-patient evaluable population, which was the pre-defined primary endpoint, increased from 29% (placebo) to 47% (talactoferrin) (one-tailed p-value = 0.05), meeting the pre-specified level of statistical significance for the primary endpoint. The evaluable population was defined as patients who received at least one dose of study drug and had at least one CT scan after the start of treatment, which is necessary to determine a response rate. The response rate in the 110-patient intent-to-treat population increased from 27% to 42% (one-tailed p=0.08). The maximum duration of treatment with talactoferrin or placebo was 18 weeks, as treatment was stopped at the same time treatment with carboplatin/paclitaxel was discontinued, even in the absence of disease progression. Median progression-free survival, overall survival, and duration of response were also longer in the talactoferrin arm, although the differences were not statistically significant.
In the study, talactoferrin appeared to be well tolerated. Patients who received talactoferrin had fewer total adverse events (two-tailed p=0.003), grade 3 or 4 adverse events (p=0.05), adverse events related to study drug or chemotherapy, incidence of serious adverse events, and discontinuations due to adverse events. The most frequently reported adverse events occurred at comparable rates in the two arms and were consistent with those typically observed in NSCLC patients undergoing chemotherapy, including myelotoxicity (affecting bone marrow), gastrointestinal disorders, respiratory disorders and alopecia (hair loss).
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 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 therapy 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. 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(TM) is a trademark of the Agennix group.
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