SOURCE: Agennix AG

Agennix  AG

January 21, 2010 04:32 ET

Agennix Expands Talactoferrin Phase 3 FORTIS-M Registration Trial Globally

MARTINSRIED, GERMANY and PRINCETON, NJ and HOUSTON, TX--(Marketwire - January 21, 2010) - Agennix AG (FRANKFURT: AGX) today announced that the next stage of the FORTIS-M trial has begun, with the first patient being dosed in Europe. FORTIS-M is a Phase 3 registration trial evaluating oral talactoferrin versus placebo in advanced non-small cell lung cancer (NSCLC) in patients whose disease has progressed following two or more prior therapies. The trial is expected to enroll approximately 720 patients. Enrollment is ongoing at sites in the U.S. and is now being expanded into Europe and the rest of the world.

"Expansion of the FORTIS-M trial to sites outside the U.S. is an important step in the continued development of talactoferrin for non-small cell lung cancer," said Rajesh Malik, M.D., Chief Medical Officer. "Patient recruitment is on track and, assuming the trial proceeds as planned, completion of enrollment is anticipated to occur sometime in the first half of 2011, with top line data available by the end of 2011."

About non-small cell lung cancer

Lung cancer is one of the most commonly diagnosed cancers worldwide and is the leading cause of cancer-related deaths around the globe. Recent statistics estimate that over 219,000 people in the U.S. and over 265,000 people in the European Union (EU) are diagnosed with lung cancer each year. Over 160,000 people in the U.S. and approximately 236,000 in the EU are expected to die from this disease annually. According to the American Cancer Society, non-small cell lung cancer (NSCLC) accounts for 85% of all newly diagnosed lung cancer in the United States. Over 50% of NSCLC cases are already metastatic and not curable when diagnosed, and the 5-year survival rate in the U.S. is only about 15%. Despite recent advances in the treatment of this disease, NSCLC continues to be a major area of unmet medical need around the world.

About the FORTIS-M trial

FORTIS-M is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial evaluating oral talactoferrin plus best supportive care compared to placebo plus best supportive care in patients with Stage IIIB/IV non-small cell lung cancer whose disease has progressed after two or more prior treatment regimens. The study is expected to enroll approximately 720 patients at clinical sites around the world. The primary endpoint of the study is overall survival. For more information about the trial, please visit www.clinicaltrials.gov.

About talactoferrin

Talactoferrin is an oral novel targeted dendritic cell recruiter and activator (DCRA) being studied mainly for the treatment of cancer and severe sepsis. Talactoferrin has demonstrated anti-cancer activity in two randomized, double-blind, placebo-controlled Phase 2 studies in NSCLC. In the Phase 2 trial in 100 patients with NSCLC whose disease had progressed following one or more prior therapies, talactoferrin showed a statistically significant improvement in overall survival compared to placebo (median survival of 6.1 vs. 3.7 months, hazard ratio: 0.68, one-tailed p-value=0.04). Talactoferrin appeared to be well tolerated in this study. The total occurrence of adverse events and severe adverse events (Grade 3/4/5) was statistically significantly lower in the talactoferrin arm compared to the placebo group (p-value=0.0013 and p-value=0.0005, respectively). No talactoferrin-related serious adverse events were reported in either Phase 2 trial in NSCLC. As a result of the promising results from Phase 2 studies, two Phase 3 studies with talactoferrin in NSCLC have been initiated. Talactoferrin has also shown activity in renal cell carcinoma, as well as severe sepsis and has been shown to be very well tolerated in all of these patient populations. The Company also has an investigational topical formulation of talactoferrin for diabetic foot ulcers.

About Agennix

Agennix AG is a publicly traded biopharmaceutical company that is developing novel therapies in areas of major unmet medical need to improve the length and quality of life of seriously ill patients. The Company's most advanced program is talactoferrin, an oral targeted therapy that is in Phase 3 clinical trials in non-small cell lung cancer. 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 is a transatlantic company with sites in 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 FORTIS-M trial will be completed in a timely manner, if at all, or that, if completed, as to what the trial results will be 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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