Isofol Medical AB today announced that the Swedish Medical Products Agency has approved the use of Isofol Medical's newly-produced vials of Modufolin for clinical trials. This enables Isofol Medical to initiate its first clinical trial on humans, the LARS2 trial. The LARS2 trial offers proof of concept of Modufolin in combination with antifolates for neoadjuvant treatment of rectal cancer patients. It is performed in collaboration with Sahlgrenska University Hospital.
”We are very pleased by this regulatory approval as access to new Modufolin® vials enables us 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” said Anders Rabbe, Isofol Medical’s CEO.
As a first step, 3000 vials of Modufolin have been manufactured in December 2010 at Unitech Pharma’s plant in Matfors, Sweden. This batch will now be released. An additional 6000 vials will be manufactured and released during March 2011. These two batches will fulfill Isofol Medical’s pre-clinical and clinical requirements of Modufolin until 2013.
Isofol Medical AB