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Isofol Medical recruits first patient in rectal cancer drug Phase I/II trial

Isofol Medical has recruited first patient in a single-center, open-label, extended feasibility Phase I/II LARS2 trial to evaluate Modufolin in conjunction with the anti-cancer drug Alimta, for the treatment of rectal cancer.

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.