April 16, 2018
Herantis Pharma Plc
Company release 16 Apr 2018 at 9:00 am
Herantis Pharma Plc (“Herantis”) announced today positive results from a safety evaluation in the ongoing Phase 1 clinical study assessing the safety and tolerability of the company’s investigational gene therapy product Lymfactin® in the treatment of secondary lymphedema. Based on data from all 15 patients recruited, the study’s Data Monitoring Committee (“DMC”) of independent experts concluded that Lymfactin® continues to appear safe and well tolerated. No dose limiting toxicities were observed. The safety evaluation was based on all available clinical data at approximately eight weeks after the last dosing of Lymfactin®. Based on the DMC assessment, Herantis can proceed with a Phase 2 clinical study to investigate the therapeutic effect of Lymfactin® over placebo on reducing the swelling, immobility, pain, and other symptoms associated with lymphedema.