Agennix AG Initiates Phase II/III OASIS Trial With Talactoferrin in Severe Sepsis

PLANEGG, GERMANY and MUNICH, GERMANY and PRINCETON, NJ and HOUSTON, TX--(Marketwire - June 30, 2011) - Agennix AG (FRANKFURT: AGX) (XETRA: AGX) today announced that the first patient has been dosed in the Phase II part of the OASIS (Oral Talactoferrin in Severe Sepsis) trial, a multicenter, double-blind, randomized Phase II/III trial evaluating the oral immunotherapy talactoferrin for the treatment of severe sepsis.

“With over 450,000 people in the U.S. and Europe alone estimated to die from severe sepsis every year, there is an urgent need for effective and well tolerated therapies to treat this very sick patient population,” said Rajesh Malik, M.D., Chief Medical Officer. “Building on the promising results from our earlier Phase II study with talactoferrin in severe sepsis, the OASIS trial should give us important insight into the potential utility of talactoferrin as a treatment for this major unmet medical need.”

The OASIS trial is evaluating talactoferrin plus standard care compared to placebo plus standard care in adult patients with severe sepsis. The Phase II part of the trial is planned to enroll approximately 350 patients at clinical sites predominantly in Western Europe and North America. The study’s primary objective is to determine the effect of talactoferrin on 28-day all-cause mortality. Secondary endpoints include three-month, six-month and twelve-month all-cause mortality. The study will also evaluate the safety and tolerability of talactoferrin in this patient population, and data will be collected to further elucidate the mechanism of action of talactoferrin. Additional information about the trial can be found at www.clinicaltrials.gov.

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 non-small cell lung cancer (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 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, 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.