Isofol Medical AB today announced that it successfully has completed the first part of its preclinical safety program on Modufolin®. The GLP program performed shows no Modufolin®- related toxicity in animals. Preliminary data from two separate clinical trials also show that Modufolin® is safe when administered to patients in the dose range evaluated. The company has also recently received preliminary data which indicates that Modufolin® enables substantially greater exposure to and peak concentrations of MTHF than those obtained after administration of Levoleucovorin (L-LV).
Results from pre-clinical investigations in animal models, performed accordingly to the ICH S9 guidance, show that Modufolin® is safe at the highest dose-levels administered to rats (100mg/kg/day) and dogs (50mg/kg/day). Clinical data furthermore show that Modufolin® administered in doses of up to 200 mg/m2 is safe for patients.
Isofol has also received preliminary data from the first 16 patients in the ongoing study, ISO-CC-002. The trial is a single-blinded, randomized phase I/II study performed on up to 64 patients with colon cancer. The study investigates pharmacokinetic and pharmacodynamic properties of Modufolin® compared to levoleucovorin in tumor tissue, adjacent mucosa and blood plasma. The first interim analysis demonstrates that administration of Modufolin® enables substantially greater exposure and peak concentrations of Methylenetetrahydrofolate (MTHF) than those obtained after administration of Levoleucovorin (L-LV).
”It is with great satisfaction that we can demonstrate positive safety data from both pre clinical and clinical trials. The data demonstrate that Modufolin® is safe for patients, and these studies are milestones in the ongoing development program of Modufolin®. We have also received information that supports the hypothesis of Isofol that Modufolin has a pharmacological advantage compared to Levoleucovorin (L-LV)”, said Anders Rabbe, CEO of Isofol Medical.
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® does not require enzymatic metabolic activation which may improve the therapeutic efficacy and safety as well as reliability for all patients receiving folate-based treatments with Modufolin®. Isofol Medical AB is currently evaluating Modufolin® in two clinical phase I/II studies.
About Isofol Medical
Isofol Medical is a clinical stage pharmaceutical company developing novel products for unmet needs within oncology. Isofol’s lead clinical candidate Modufolin® ([6R] 5,10-methylene tetrahydrofolate) is an endogenous folate-based biomodulator developed to increase the efficacy and decrease the side effects of chemotherapeutic agents used in the treatment of solid tumors. Isofol Medical collaborates closely with its strategic R&D partner Merck Millipore, the world’s leading manufacturer of reduced folates including leucovorin and levoleucovorin.
For more information, please contact:
Anders Rabbe, CEO, Isofol Medical AB
Phone: +46 (0)707 646 500