Modufolin (6R-5,10-methylenetetrahydrofolate) is a novel folate-based drug developed to increase the efficacy and reduce the side effects of antimetabolites used in cancer treatment.
However, Eli Lilly’s Alimta is a folate analog metabolic inhibitor indicated for locally advanced or metastatic nonsquamous Non-Small Cell Lung Cancer and Mesothelioma.
In the Phase I/II trial, the company is planning to investigate Alimta (at 500mg/m2) with Modufolin (at 100, 50 or 10mg/m2) in 43 to 58 chemo-naive patients with newly diagnosed operable rectal cancer.
The study is being conducted in collaboration with the principal investigator Bengt Gustavsson and the Sahlgrenska University Hospital in Goteborg, Sweden.