Isofol Medical AB today announced that the company has enrolled its first patient in the explorative phase I/II trial, LARS2, for the treatment of rectal cancer. A total of 43 to 58 patients will receive Isofol’s novel folate-based drug Modufolin® in combination with the anti-cancer drug Alimta®.
”This is a significant landmark in Isofol’s development since the LARS2 trial is the first human trial with our novel folate-based drug Modufolin®. We have great expectations on Modufolin® as pre-clinical data suggest an increased anti-tumor effect and reduced side effects of Alimta® when administered in combination with Modufolin®. We furthermore hope that the treated patients will experience the advantage of pre-operative treatment”, says Anders Rabbe, Isofol Medical’s CEO.
The LARS2 trial is a single-center, open-label, extended feasibility study of Alimta® (at 500 mg/m2) with Modufolin® (at 100, 50 or 10 mg/m2) in 43 to 58 chemo-naive patients with newly diagnosed operable rectal cancer. The study is performed in collaboration with the principal investigator Prof. Bengt Gustavsson and the Sahlgrenska University Hospital in Göteborg, Sweden.
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. Modufolin® is the key active metabolite of the widely used folate-based drug Leucovorin. Modufolin® stabilizes the binding of certain antimetabolites to the target enzyme Thymidylate Synthase (TS) and, in contrast to Leucovorin, does not require enzymatic metabolic activation which allows for a better therapeutic effect.
Alimta® (Eli Lilly and Co) is a folate analog metabolic inhibitor indicated for locally advanced or metastatic nonsquamous Non-Small Cell Lung Cancer and Mesothelioma.
About Isofol Medical AB
Isofol Medical is based on 30 years of medical research which has resulted in the novel folate-based pharmaceutical product Modufolin®. Modufolin® is anticipated to increase the efficacy and reduce the side effects of cytotoxic pharmaceuticals. Isofol works closely with its strategic Swiss R&D partner Merck & Cie, the world’s leading manufacturer of reduced folates. In parallel to the drug development, Isofol Medical is performing diagnostic research to personalize and optimize the use of folate-based therapies for cancer treatment.
For more information, please contact:
Anders Rabbe, CEO, Isofol Medical AB
Phone: +46 (0)707 646 500