Herantis announces initial plans for continued development of Lymfactin

Herantis Pharma’s clinical study with its investigational gene therapy product Lymfactin for treating secondary lymphedema has advanced to the last patient cohort, owing to good reported safety, the company said Thursday.

After assessing safety data on all treated patients, including the first patients treated with the highest dose, the study’s Data Monitoring Committee of independent experts recommended proceeding with the study as planned. With the recommendation the study centers can proceed to recruit patients at their own pace on the high dose level. Herantis says that until now there has been a precautionary safety monitoring period following each patient treatment.

Herantis estimates that, as previously informed, the ongoing Phase 1 clinical study will complete patient recruitment by the end of 2017. In addition, encouraged by the strong reported safety data so far, the company aims to submit an application to regulatory authorities by the end of 2017 for a Phase 2, randomized, placebo-controlled clinical study on Lymfactin. The company has started discussions on a Phase 2 study with regulatory authorities and study centers.

The Phase 1 clinical study continues recruiting patients with breast cancer associated lymphedema at three university hospitals in Finland: In Helsinki, Tampere, and Turku. The intention is to recruit a total of 15 patients in the clinical study by the end of 2017.