Information about new clinical studies will be published on this site and the study sponsor’s website when applicable (www.herantis.com)
The ongoing Phase 2 clinical study AdeLE (”Adenoviral gene therapy for the treatment of LymphEdema”) is a multi-center, randomized, double-blind, placebo-controlled study in patients with secondary lymphedema associated with the treatment of breast cancer and is currently in the follow-upp stage. A total of 39 patients were recruited in the study; new patients cannot be included in the study anymore. The study will assess the efficacy, safety, and tolerability of Lymfactin® in patients undergoing lymph node transfer surgery. Half of the patients will receive one dose of Lymfactin® and half will receive placebo. All patients will undergo a lymph node transplantation surgery, which can be of benefit for the patients regardless of being in the Lymfactin® group or placebo group.
The AdeLE study intends to assess the safety and efficacy of Lymfactin® in the treatment of breast cancer associated lymphedema when combined with a conventional lymph node transplantation surgery. The impact of the treatment on the lymphedema, quality of life of the patient, and possible adverse reactions are monitored in the study. In addition, the clinical study will investigate the distribution of the drug substance in the body and compare different methods of assessing the symptoms of lymphedema.
The combination of Lymfactin® and lymph node transplantation surgery has been assessed previously in 15 patients in a Phase 1 clinical study in Finland. Based on the results Lymfactin® is safe and well tolerated.