Lymfactin® for lymphedema
Lymphedema (LE) means chronic, progressive swelling of the affected tissues due to dysfunction of the lymphatic system. It is a disabling and disfiguring disease, which severely affects the patients’ quality of life. There is no cure.
Secondary LE is a common consequence of cancer therapies with an estimated 150,000 cases of cancer-associated LE diagnosed annually in Europe and the USA. There are no approved medicines for the treatment of LE; while available therapies such as compression garments and exercise alleviate the symptoms, there is no cure.
Herantis’ Lymfactin® is the world’s first and only clinical stage gene therapy that repairs damages of the lymphatic system. It expresses the human growth factor VEGF-C, which is natural and specific for the development of lymphatic vessels. Based on preclinical studies, Lymfactin® triggers the growth of new functional lymphatic vasculature in the damaged area and thus repairs the underlying cause of secondary lymphedema. Lymfactin®, patented by Herantis, is based on the internationally renowned scientific research of academy professor Kari Alitalo and his research group, a national centre of excellence at the University of Helsinki.
Lymfactin® is currently in the Phase 2 clinical study AdeLE (Adenoviral gene therapy for the treatment of LE). AdeLE is a Phase 2 multi-center, randomized, double-blind, placebo-controlled study in patients with secondary lymphedema associated with the treatment of breast cancer. The study is planned to enrol 40 patients in Finland and Sweden and will assess the efficacy, safety and tolerability of a single dose of Lymfactin® compared to placebo in patients undergoing lymph node transfer surgery. Primary endpoints include volumetric measurements of the arm, quantitative lymphoscintigraphy, and quality-of-life assessment.
Data from a Phase 1 clinical study in 15 patients with breast cancer associated LE suggest Lymfactin® is safe and well tolerated. The Phase 1 study continues with follow-up on the patients.
Participation in the AdeLE study
If you are interested in participating in the Phase 2 clinical study AdeLE please contact the study nurse at the hospital most conveniently located for you. The e-mail addresses for the currently recruiting study sites are:
- Helsinki University Hospital: Study nurse Kira Olenius, kira.e.olenius (at) hus.fi
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.