Herantis Pharma clinical study with the company’s innovative gene therapy investigational product Lymfactin for the treatment of secondary lymphedema has advanced to highest planned dose level owing to good reported safety.
As the company said in its press release, Data Monitoring Committee of independent experts has recommended proceeding to high dose treatments after assessing safety data on the previously treated patients. Following the recommendation, the first high dose treatment has already been administered, said the company.
Pekka Simula, Herantis’ CEO said, “This is the first clinical study in the world to apply gene therapy for repairing damages of the lymphatic system.”
“Collaboration with the participating university hospitals in this study has been excellent”, Katarina Jääskeläinen, Herantis’ Project Manager for the clinical study commented. “Secondary lymphedema is a disfiguring, disabling disease that severely impacts the quality of life of patients.” Jääskeläinen added.
Approximately 20% of breast cancer patients who undergo axillary lymph node dissection develop secondary lymphedema, a chronic, progressive, disabling and disfiguring disease that causes a chronic swelling of an upper limb, thickening and hardening of skin, loss of mobility and flexibility, pain, and susceptibility to secondary infections.
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 study intends to recruit at most 18 patients by the end of 2017, the company announced in its press release.
March 6 was officially recognized World Lymphedema Day since 2015 by e.g. the U.S. Senate. It is celebrated around the world largely thanks to the patient advocacy group Lymphatic Education & Research Network (LE&RN) to increase lymphedema awareness.