First patient enrolled in Isofol Medical’s initial trial with Modufolin® for treatment of neoadjuvant rectal cancer

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.

About Modufolin®
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.

About Alimta®
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
E-mail: anders.rabbe@isofolmedical.com
Phone: +46 (0)707 646 500