Herantis Pharmaceuticals has announced positive results from a safety evaluation of its Phase I clinical trial of Lymfactin, the company’s investigational gene therapy product, as a treatment for secondary lymphoedema.
The study’s Data Monitoring Committee (DMC) said Lymfactin showed consistent safety and tolerability, with no dose-limiting toxicities observed. The evaluation was based on all clinical data available at approximately eight weeks following the final dose of Lymfactin, taken from all 15 subjects enrolled in the study.
The DMC’s approval means the company can move on to a Phase II study of Lymfactin, examining its efficacy in reducing patients’ swelling, immobility and pain, compared with placebo.
The current study sees Lymfactin administered in combination with lymph node transfer surgery, the current standard of care treatment for secondary lymphoedema.
As well as safety and tolerability, the trial is also examining the treatment’s effect on quality of life. Findings have shown an increase for this criterion, as measured by Lymphoedema Quality of Life Inventory. However, as this has not been assessed against a control group it will need to be followed up in the Phase II study.
"We are very grateful to everyone involved in this study and also to patients all over the world whose supporting messages have encouraged us," Herantis CEO Pekka Simula said.
"Lymphoedema, 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."
Finland-based Herantis has announced plans for a randomised Phase II study of Lymfactin as a treatment for breast cancer-associated lymphoedema, with a clinical trial application already submitted to regulatory authorities.
Lymphoedema is a condition that develops when the lymphatic system stops working properly, causing a build-up of fluid in the body’s tissues. Patients can experience either primary or secondary lymphoedema, the former of which is caused by faulty genes and the latter of which follows an infection, injury or cancer treatment.
Around 20% of breast cancer patients who undergo axillary lymph node dissection develop secondary lymphoedema. Symptoms include severe swelling of the upper limb, a hardening of the skin, loss of mobility and flexibility, pain, and susceptibility to secondary infections.
Current treatment options include compression garments such as sleeves or stockings, special massages, and exercises. Though these help to alleviate symptoms, they cannot cure the condition. There are currently no approved medicines for treating the disease.
Lymfactin works to repair damage in the lymphatic system by using the growth factor VEGF-C, which is specific to the development of lymphatic vessels. The therapy platform stimulates the growth of a new functional lymphatic vasculature in the damaged area, targeting the underlying cause of secondary lymphoedema in the process.