Herantis Pharma has gotten positive results from a safety evaluation in the ongoing Phase 1 clinical study of its investigational gene therapy product Lymfactin for the treatment of secondary lymphedema.
Herantis said that, based on data from all 15 patients recruited, the study’s Data Monitoring Committee (DMC) of independent experts concluded that Lymfactin continues to appear safe and well tolerated. No dose limiting toxicities were observed.
The safety evaluation was based on all available clinical data at approximately eight weeks after the last dosing of Lymfactin. Based on the DMC assessment, Herantis can proceed with a Phase 2 clinical study to investigate the therapeutic effect of Lymfactin over placebo on reducing the swelling, immobility, pain, and other symptoms associated with lymphedema, Herantis said.
Outi Lahdenperä, Herantis’ Chief Medical Officer is pleased with the positive data, noting that they provide a strong basis for continued clinical development as planned.
Pekka Simula, Herantis’ CEO, said: “Lymphedema, or LE, is a fairly common yet frequently overlooked disease. Fortunately, the international patient advocacy group LE&RN is making a significant difference in increasing awareness of the disease. We hope to make a similar difference in its treatment.”
Herantis said in the press release that it intends to proceed rapidly to a randomized, placebo-controlled Phase 2 study of Lymfactin for the treatment of breast cancer associated lymphedema. The company has also said that it has already submitted the clinical trial application to regulatory authorities.