A Phase I Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema

Phase 1 Terminated 15 enrolled Herantis Pharma Plc.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Indicated for the Treatment of Secondary Lymphedema Associated with the Treatment of Breast Cancer. Primary objective is to evaluate the safety and tolerability of a single dose of Lymfactin® in patients with secondary lymphedema associated with the treatment of breast cancer.

Timeline

Start: 2016-06
Primary completion: 2019-02-03
Completion: 2022-04-05

Outcome

Outcome not reported

Stopped: “Lack of efficacy”

Publications

Pajula S, Saarikko A, Suominen S, Kaartinen I, Kiiski J, Suominen E, Viitanen T, Maki M, Seppanen M, Lahdenpera O, Alitalo K, Hartiala P. Lymfactin(R) gene therapy with vascularized lymph node transfer reduces compression-free swelling and enhances quality of life in breast cancer-related lymphedema: Final Phase I trial results. J Plast Reconstr Aesthet Surg. 2025 Dec;111:312-321. doi: 10.1016/j.bjps.2025.10.013. Epub 2025 Oct 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Lymfactin®	Unknown	1e+10 unknown	Other
Comparator	Lymfactin®	Unknown	1e+11 unknown	Other