The topline results from the 12-month follow-up review of the Phase 1 Lymfactin trial in breast cancer-associated lymphedema has been announced.
The study’s data monitoring committee (DMC) concluded that the treatment continues to be safe and well-tolerated in all patients with no severe adverse events. Lymfactin, the novel gene therapy of Herantis that aims to repair the damaged lymphatic system in breast-cancer associated lymphedema patients, is currently in a multi-center Phase 2 clinical study AdeLE in Sweden and Finland.
“We are encouraged by the additional confirmation of the safety and tolerability of Lymfactin from the 12-month review. These data remain in line with what we have seen in our first interim analysis. This is a promising step for lymphedema patients who currently only have limited symptomatic treatment options, none of which render long-lasting therapeutic effects,” commented Pekka Simula, CEO of Herantis Pharma. “Following the positive safety data, we look forward to a more in-depth investigation of the benefits of Lymfactin in the ongoing Phase 2 AdeLE study, for which we expect initial results by the end of 2020.”
About the Phase I study
The Phase 1 study enrolled a total of 15 patients from three university hospitals in Finland: Helsinki, Tampere and Turku. Lymfactin was administered in a single dose following lymph node surgery. Safety and tolerability were assessed at baseline, 6-months and 12-months post-treatment. Based on the promising interim results announced in April 2018, Herantis has initiated the placebo-controlled Phase 2 AdeLE trial in June 2018.