Herantis Pharma announces positive interim data from Lymfactin study in secondary lymphedema

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.

In the current study, Lymfactin® is combined with lymph node transfer surgery, which is a standard of care for secondary lymphedema. In addition to safety and tolerability, the trial evaluates for instance the quality of life of the patients. The quality of life has improved consistently after treatment as measured by mean scores assessed by Lymphedema Quality of Life Inventory. Although encouraging, the quality of life data have not been substantiated against a control group in this study and therefore this and other possible benefits need to be assessed in a follow-up Phase 2 study including a placebo control. The Phase 1 study continues with a 12-month follow-up on the patients.

"The safety and well-being of patients is always our first priority," commented Outi Lahdenperä, MD, PhD, Herantis' Chief Medical Officer. "We are of course very pleased with these positive data that provide a strong basis for continued clinical development as planned."

"We are very grateful to everyone involved in this study and also to patients all over the world whose supporting messages have encouraged us," adds Pekka Simula, Herantis' CEO. "Lymphedema, or LE, is a fairly common yet frequently overlooked disease. Fortunately, the international patient advocacy group LE&RN is making a significant difference in increasing awareness of the disease. We hope to make a similar difference in its treatment."

Herantis intends to proceed rapidly to a randomized, placebo-controlled Phase 2 study of Lymfactin® for the treatment of breast cancer associated lymphedema. The company has already submitted the clinical trial application to regulatory authorities

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