SOURCE: Agennix AG

Agennix AG

October 11, 2011 04:20 ET

Agennix Announces Data From Talactoferrin Phase II Trial in Non-Small Cell Lung Cancer Published in Journal of Clinical Oncology

PLANEGG, GERMANY and MUNICH, GERMANY and PRINCETON, NJ and HOUSTON, TX--(Marketwire - Oct 11, 2011) - Agennix AG (FRANKFURT: AGX) today announced that data from a Phase II randomized, double-blind, placebo-controlled clinical trial evaluating the oral immunotherapy, talactoferrin, in patients with previously treated non-small cell lung cancer (NSCLC) have been published in the peer-reviewed medical journal, Journal of Clinical Oncology. The article, "A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Oral Talactoferrin in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer that Progressed Following Chemotherapy," by P. Parikh et al, will appear in the November 1, 2011 print issue of the journal. As previously reported, this study, conducted in patients with NSCLC for whom one or more prior lines of anti-cancer therapy had failed, achieved its primary endpoint of improvement in overall survival. Talactoferrin also appeared to improve survival across a broad range of patient subsets, including those with squamous and non-squamous histologies, as well as other important prognostic factors. The results of this study served as the basis for the ongoing talactoferrin Phase III FORTIS-M trial, which is being conducted in patients whose disease has progressed following two or more prior treatment regimens. The FORTIS-M study has completed enrollment and topline results are expected in the first half of 2012.

"There is a major need for effective, easy-to-use, well tolerated treatments for patients with refractory non-small cell lung cancer," said Rajesh Malik, M.D., Chief Medical Officer. "The promising results from this study show the potential of talactoferrin to improve survival where previous therapies have failed, including effects across a broad range of clinically important subsets. Talactoferrin appears to provide anti-tumor activity without many of the common toxicities associated with other treatments for non-small cell lung cancer. In addition, talactoferrin is an oral liquid that offers convenience for both patients and physicians to use. We look forward to reporting topline results from our ongoing Phase III FORTIS-M registration trial in advanced non-small cell lung cancer in the first half of 2012."

The published randomized Phase II trial enrolled 100 patients with stage IIIB/IV non-small cell lung cancer whose disease had progressed following one or more lines of anti-cancer therapy and evaluated the use of talactoferrin plus best supportive care compared to placebo plus best supportive care. The results showed that talactoferrin improved median overall survival by 65% compared to placebo [6.1 months versus 3.7 months, hazard ratio = 0.68, 90% Confidence Interval: 0.47-0.98, p=0.04 (one-tailed log-rank test)], meeting the protocol-defined level of statistical significance. The six-month overall survival rate was 30% in the placebo arm and 52% in the talactoferrin arm. The one-year overall survival rate was 16% in the placebo arm compared to 29% in the talactoferrin arm. Supportive results were seen in the secondary endpoints of progression-free survival and disease control rate. The above analyses were conducted on an intent-to-treat basis.

Talactoferrin was shown to be very well tolerated in this study, with fewer adverse events compared to placebo. The most frequently reported severe (grade 3 or greater) 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.

About talactoferrin
Talactoferrin is an oral immunotherapy that 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 developing talactoferrin for the treatment of severe sepsis and has initiated a Phase II/III trial, called the OASIS 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 a Phase II/III trial with talactoferrin in severe sepsis is underway. 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

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. The achievement of positive results in early stage clinical studies does not ensure that later stage or large scale clinical studies will be successful. 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, there can be no guarantee that they will be sufficient to gain marketing approval in the United States or any other country, and 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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