Agennix AG announced the completion of patient enrollment in the talactoferrin FORTIS-M phase III registration trial. The FORTIS-M trial is a global randomized, double-blind trial evaluating talactoferrin plus best supportive care compared to placebo plus best supportive care in patients with Non-Small Cell Lung Cancer (NSCLC) whose disease has progressed following two or more prior treatment regimens. The study enrolled 742 patients at over 160 sites globally.
“We are excited to have accomplished this important milestone in the development of talactoferrin by completing accrual in the FORTIS-M trial within the expected timeline,” said Rajesh Malik, MD, chief medical officer. “There is a major need for effective and well-tolerated treatments for non-small cell lung cancer patients whose disease has already progressed after multiple therapies. I would like to thank the clinical investigators and study site personnel for their dedication, as well as the patients and their families who are participating in the trial.”
The company also provided an update on the anticipated availability of topline data from the FORTIS-M trial. Agennix now expects to see these data in the first half of 2012. This updated timeline is based on currently available information on the number of blinded death events in the study and is subject to further change. The company will provide updates as appropriate when more information becomes available.
Lung cancer is one of the most commonly diagnosed cancers worldwide and is the leading cause of cancer-related deaths around the globe. In the US, more people die of lung cancer than of colon, breast and prostate cancers combined. According to the American Cancer Society, NSCLC accounts for approximately 85 per cent of all newly diagnosed lung cancer in the US. The symptoms of lung cancer usually do not appear until the disease is already in an advanced stage. Thus, over 50 per cent of NSCLC cases are already metastatic and not curable at the time of diagnosis. Despite recent advances in the treatment of this disease, NSCLC continues to be a major area of unmet medical need around the world.
Talactoferrin is an oral biologic therapy with immunomodulatory and antibacterial properties, which is being studied for the treatment of cancer and severe sepsis. It has demonstrated activity in randomized, double-blind, placebo-controlled phase II studies in Non-Small Cell Lung Cancer (NSCLC), as well as in severe sepsis, a condition with significant mortality marked by severe inflammation in response to a serious infection.
Agennix AG 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.