Modufolin is anticipated to increase the efficacy and reduce the side effects of cytotoxic pharmaceuticals.
The approval allows Isofol Medical to start its first clinical trial on humans, the LARS2 trial.
LARS2 trial offers proof of concept of Modufolin in combination with antifolates for neoadjuvant treatment of rectal cancer patients.
Isofol Medical CEO Anders Rabbe said they are very pleased by this regulatory approval as access to new Modufolin vials enables them to directly initiate the already approved LARS2 trial.
"Isofol would like to thank both Unitech Pharma and Merck & Cie for their strong efforts throughout the manufacturing process," Rabbe said.