Lymfactin® for lymphedema
Lymphedema means chronic, progressive swelling of affected tissues. Approximately 20% of breast cancer patients who undergo axillary lymph node dissection get secondary lymphedema, a disabling and disfiguring condition that severely affects quality of life. There is no cure.
Over 200,000 patients in the USA and Europe are estimated to live with breast-cancer associated lymphedema, with an estimated 30,000 new patients developing the complication each year. Secondary lymphedema is currently treated e.g. with compression garments, special massage, and exercises. While these therapies may relief the symptoms they do not cure the condition, which is caused by damage to the lymph system.
Herantis’ Lymfactin® aims at recovering the damaged lymph system by reconstituting lymphatic vasculature. Preclinical pharmacology studies in lymphedema models have confirmed the effects of Lymfactin® on growth of new functional lymphatic vessels and functional improvement of lymphatic flow.
Herantis launched a phase I clinical study in 2016 in women with breast cancer associated secondary lymphedema. While the primary endpoint of the study is to assess the safety and tolerability of Lymfactin®, the study will also assess the preliminary efficacy of the treatment. A total of 15 patients were enrolled in the phase I clinical study; the enrollment was completed in February 2018. The study continues with a 12-month follow-up on the patients.
The company intends to proceed rapidly to a randomized, placebo-controlled Phase 2 study of Lymfactin® in the same indication and has already submitted the clinical trial application to the regulatory authorities.
Introductory video on Lymfactin®
Herantis is a member of the non-profit organisation LE&RN (Lymphatic Education & Research Network) whose vision is a world without Lymphedema. Herantis and LE&RN provide an introductory video on Lymfactin®, which is available here.