Finnish Medicines Agency authorization of first-in-man clinical study with Lymfactin
Herantis Pharma Plc.
Company release 13 November 2015, 9:00 am
Finnish Medicines Agency Fimea has authorized Herantis Pharma Plc’s (“Herantis”) first-in-man clinical study of Lymfactin® for the treatment of breast-cancer associated lymphedema. Patient recruitment in the clinical study is planned to begin in Finland in the first half of 2016.
“There are no approved medicines for breast-cancer associated lymphedema”, says Burkhard Blank, MD, Chief Medical Officer of Herantis. “The symptoms are currently treated by compression garments, special massage, and exercises, which do not cure the cause of lymphedema. With Lymfactin® we aim exactly at that: Cure for lymphedema by recovering the damaged lymph system.”
“We estimate that more than 30,000 new patients suffering from breast-cancer associated lymphedema are diagnosed every year in Europe and USA”, adds Pekka Simula, CEO of Herantis. “We hope that our development program will eventually contribute to significantly improving the quality of life of hundreds of thousands of patients.”
In this clinical study a single dose Lymfactin® administration is combined with a surgical operation where the patient’s own lymph node tissue is transferred into the damaged area. Herantis will continue preparations of the clinical study and will issue a separate release upon commencing patient recruitment. Broadview Ventures I, LLC, a shareholder in Herantis, has committed to subscribing to 32,311 new shares of Herantis for a subscription price of €10.00 per share after Herantis receives authorization for a clinical study with Lymfactin®.
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 2538 0254
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 condition that severely affects 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 they do not cure the condition, which is caused by damage to the lymph system. There are currently no approved medicines for this condition.
Lymfactin® is an adenovirus-based gene therapy expressing the growth factor VEGF-C specific in the lymphatic system. In preclinical studies Lymfactin® has been administered in the tissue surrounding lymph nodes, which is considered comparable to administration in a surgical procedure as planned in the first-in-man clinical study with Lymfactin®. Lymfactin® is expected to improve growth of lymphatic vessels. Lymfactin® is based on the academic research of professor Kari Alitalo and his research group at the University of Helsinki.
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 a pharmaceutical company specialised in new drug research and development. The company focuses on diseases with an unmet clinical need. These diseases include for example Parkinson’s disease and secondary lymphedema. The shares of Herantis are listed on the First North Finland marketplace run by Nasdaq Helsinki stock exchange.