Isofol Medical AB today announced that the first patient treated with Modufolin®, as rescue therapy, after treatment with two cycles of HDMX successfully fulfilled the study objectives. The patient is participating in a Phase I/II open-label, multicenter clinical trial where each patient is evaluated during two treatment cycles with HDMTX and Modufolin®. This is a safety/efficacy study in 3-6 patients and is intended to identify the dose with most favorable safety that mitigates HDMTX induced toxicity.
This is the first study in which HDMTX rescue therapy with Modufolin® is investigated, and Isofol predicts that Modufolin® will give more reproducible, reliable and thus robust rescue treatment with HDMTX than leucovorin or levoleucovorin, this hypothesis is firmly underpinned by science. Previous clinical results have shown no Modufolin® related side effects observed at dose levels between 10-500 mg/m2 after more than 240 administrations
“I am very pleased that the first patient now has been treated with Modufolin® in this study and that the study objectives were fulfilled successfully. This study is an important part of our development strategy for Modufolin® and is planned to help us define the safe and efficacious dose of Modufolin® when administered as a rescue therapy with high dose methotrexate treatment in osteosarcoma patients” said Anders Rabbe, CEO of Isofol Medical.
Modufolin®(chemical name [6R]-5,10-methylenetetrahydrofolate), is a novel folate-based compound developed to increase the efficacy and reduce the side effects of antimetabolites used in cancer treatment. It is the key active metabolite of all clinically used folate-based drugs today including leucovorin and levoleucovorin and therefore does not require metabolic activation. This makes Modufolin® suitable for all patients irrespective of their capacity to activate folates and it is currently being evaluated in clinical phase II studies.
About Isofol Medical AB
Isofol Medical is a clinical stage pharmaceutical company developing novel products for unmet needs within oncology. Isofol’s lead clinical candidate is Modufolin®. 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
Modufolin® is a registered Trademark of Merck KGaA, Darmstadt, Germany.