Agennix has stopped its Phase II/III Oasis study evaluating lead candidate oral talactoferrin in the treatment of severe sepsis, after a data review by the trial’s data safety monitoring board (DSMB) found that the 28-day mortality rate was higher in the talactoferrin cohort than in the placebo cohort. The firm says the move shouldn’t impact ongoing Phase III studies investigating talactoferrin as a treatment for non-small cell lung cancer.
A full review of the Oasis study data will be carried out to determine the future for talactoferrin in the severe sepsis indication, Agennix says. "We are extremely disappointed and surprised by this result," admits CEO Rajesh Malik, M.D. "Given the challenge of treating this life-threatening condition, we had made the decision prior to initiating the Oasis trial to obtain additional clinical data before entering a large Phase III study. We will look closely at the data to better understand these results and to determine the best next steps related to further development of talactoferrin for the treatment of severe sepsis."
Talactoferrin is an orally administered dendritic cell mediated immunotherapy (DCMI) comprising a recombinant form of human lactoferrin. Two Phase III trials with talactoferrin in NSCLC are ongoing. Fortis-M is evaluating talactoferrin in NSCLC patients whose disease has progressed following two or more prior treatment regimens. Top-line data from the registrationaI Fortis-M study is expected during the second quarter of 2012. The second Phase III trial, Fortis-C, is evaluating talactoferrin in combination with standard carboplatin/paclitaxel chemotherapy as first-line therapy in NSCLC patients. Agennix has separately carried out initial clinical evaluation of a topical form of talactoferrin in the treatment of diabetic foot ulcers.
The firm’s clinical development pipeline also includes the Phase I-stage multitargeted kinase inhibitor anticancer candidate RGB-286638, and satraplatin is an oral platinum-based compound that has been tested for a variety of cancer indications and is currently under development by Yakult Honsha, Agennix’ partner for the drug in Japan.