PLANEGG, GERMANY and MUNICH, GERMANY and PRINCETON, NJ and HOUSTON, TX--(Marketwire - August 06, 2012) -
- Trial does not achieve primary endpoint
- Company to hold conference call Tuesday, August 7th at 2 PM CET/8 AM EDT
Agennix AG (FRANKFURT: AGX) (XETRA: AGX) today announced that the FORTIS-M Phase III trial with talactoferrin alfa (talactoferrin) did not meet its primary endpoint of improving overall survival. The FORTIS-M trial evaluated talactoferrin plus best supportive care compared to placebo plus best supportive care in patients with non-small cell lung cancer (NSCLC) whose disease had progressed following two or more prior treatment regimens. Median overall survival in the talactoferrin arm was 7.5 months compared to 7.7 months for placebo (hazard ratio 1.04, p-value 0.66).
Rajesh Malik, M.D., Chief Medical Officer and Member of the Management Board, said: "We are extremely disappointed and surprised with today's results, especially considering the earlier promising results we had seen in two randomized Phase II trials with talactoferrin alfa in non-small cell lung cancer. We plan to thoroughly analyze the data to better understand these results. We would like to thank all of the patients and investigators who participated in this clinical trial. We hope that the results of this study will help to advance scientific knowledge in this area, as there is an urgent need for new treatment options for patients with advanced non-small cell lung cancer."
Torsten Hombeck, Ph.D., Chief Financial Officer and Spokesperson of the Management Board, said: "We are taking immediate steps to conserve cash while we evaluate our business options. We will provide more details on our corporate plans in the near future."
The FORTIS-M trial is a randomized, double-blind, placebo-controlled Phase III trial evaluating talactoferrin plus best supportive care compared to placebo plus best supportive care in Stage IIIb/IV NSCLC patients whose disease has progressed following two or more prior treatment regimens. There were 742 patients enrolled in the trial from over 160 clinical sites in North America, Europe and the Asia/Pacific region.
The nature and incidence of adverse events in the talactoferrin arm were similar to that of placebo and consistent with previous clinical trials.
Conference Call Scheduled
Agennix has scheduled a conference call, which will be conducted in English, to be held on Tuesday, August 7, 2012 at 8 AM EDT/2 PM CET. A live webcast will be available on the Agennix Web site at www.agennix.com. A replay will be available via the Web site following the live event.
Dial-in numbers for the call are as follows:
Participants from Europe:
0049 (0)69 7104 45598
0044 (0)20 3003 2666
Participants from the U.S.:
1 212 999 6659
Please dial in 10 minutes before the beginning of the conference call.
Agennix AG is a publicly listed biopharmaceutical company that is focused on the development of novel therapies that have the potential to substantially lengthen and improve the lives of critically ill patients in areas of major unmet medical need. The Company's most advanced investigational agent is talactoferrin alfa, a first-in-class oral Dendritic Cell Mediated Immunotherapy (DCMI). Talactoferrin alfa is currently being studied for the treatment of non-small cell lung cancer. Other clinical development programs include RGB-286638, a multi-targeted kinase inhibitor in Phase I testing for cancer, 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 those 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. There can be no guarantee that the Company will have or be able to obtain the financial resources to conduct additional studies with talactoferrin alfa or other product candidates or that such studies will yield results sufficient for approval. There can be no guarantee that the Company will be able to partner talactoferrin alfa or obtain additional financial resources. 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 Agennix AG.