Herantis Pharma Plc (“Herantis”) announced today positive results from a safety evaluation in the ongoing Phase 1 clinical study assessing the safety and tolerability of the company’s investigational gene therapy product Lymfactin® in the treatment of secondary lymphedema. 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.
In the current study, Lymfactin® is combined with lymph node transfer surgery, which is a standard of care for secondary lymphedema. In addition to safety and tolerability, the trial evaluates for instance the quality of life of the patients. The quality of life has improved consistently after treatment as measured by mean scores assessed by Lymphedema Quality of Life Inventory. Although encouraging, the quality of life data have not been substantiated against a control group in this study and therefore this and other possible benefits need to be assessed in a follow-up Phase 2 study including a placebo control. The Phase 1 study continues with a 12-month follow-up on the patients.
“The safety and well-being of patients is always our first priority,” commented Outi Lahdenperä, MD, PhD, Herantis’ Chief Medical Officer. “We are of course very pleased with these positive data that provide a strong basis for continued clinical development as planned.”
“We are very grateful to everyone involved in this study and also to patients all over the world whose supporting messages have encouraged us,” adds Pekka Simula, Herantis’ CEO. “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 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 already submitted the clinical trial application to regulatory authorities.
Herantis Pharma Plc, Pekka Simula, CEO, telephone: +358 40 7300 445
Company web site: www.herantis.com
Certified Advisor: UB Securities Ltd, telephone: +358 9 25 380 225
About breast cancer associated lymphedema
Approximately 20% of breast cancer patients who undergo axillary lymph node dissection develop secondary lymphedema, a chronic, progressive, disabling and disfiguring disease that severely affects the quality of life. Symptoms include a chronic swelling of an upper limb, thickening and hardening of skin, loss of mobility and flexibility, pain, and susceptibility to secondary infections. Secondary lymphedema is currently treated with compression garments, special massage, and exercises. While these therapies may relief the symptoms in some patients they do not cure lymphedema, which is caused by damage to the lymphatic system. There are currently no approved medicines for the treatment of this condition.
Lymfactin® is world’s first and only clinical stage gene therapy repairing damages of the lymphatic system. It expresses the growth factor VEGF-C, which is specific for the development of lymphatic vessels. Based on preclinical studies, Lymfactin® triggers the growth of new functional lymphatic vasculature in the damaged area and thus repairs the underlying cause of secondary lymphedema. Interim data from a clinical Phase 1 study suggest Lymfactin® is safe and well tolerated. Lymfactin®, patented by Herantis, is based on the internationally renowned scientific research of academy professor Kari Alitalo and his research group, a national centre of excellence at the University of Helsinki. Herantis also holds patents for a combination therapy, which may expand the use of Lymfactin® in other lymphedemas. See our introductory video on Lymfactin®: http://herantis.com/media/videos/
About drug development in general
Drug development projects can usually be divided in two stages: The preclinical stage, and the clinical stage involving human subjects. The clinical stage can be further broken in three formal phases. Phase 1 clinical studies assess the safety of a drug candidate in human subjects. In Phase 2, the optimal dosing and possible efficacy in the treatment of a particular disease is studied. Phase 3 studies finally aim to establish a statistical proof of safety and efficacy of the drug candidate in typically hundreds or thousands of patients for market approval. Drug development can take 10-15 years from the first preclinical studies to market approval.
About Herantis Pharma Plc
Herantis Pharma Plc is an innovative drug development company focused on regenerative medicine and unmet clinical needs. Our clinical stage assets CDNF and Lymfactin® are based on globally leading scientific research in their fields. They both aim at breakthrough in the treatment of severe diseases: CDNF in neurodegenerative diseases such as Parkinson’s disease; and Lymfactin® in breast cancer associated lymphedema with potential also in other lymphedemas. The shares of Herantis are listed on the First North Finland marketplace run by Nasdaq Helsinki stock exchange.