Herantis Pharma’s Lymfactin study advances to last patient cohort, company announces initial plans for continued development
Herantis Pharma's Lymfactin study advances to last patient cohort, company announces initial plans for continued development
Herantis Pharma Plc
Company release 22 June 2017 at 9:00 am
Herantis Pharma Plc's ("Herantis") clinical study with the company's investigational gene therapy product Lymfactin® for the treatment of secondary lymphedema has advanced to the last patient cohort, owing to good reported safety. After assessing safety data on all treated patients, including the first patients treated with the highest dose, the study's Data Monitoring Committee of independent experts recommended proceeding with the study as planned. With the recommendation the study centers can proceed to recruit patients at their own pace on the high dose level. Until now there has been a precautionary safety monitoring period following each patient treatment.
Herantis estimates that, as previously informed, the ongoing Phase 1 clinical study will complete patient recruitment by the end of 2017. In addition, encouraged by the strong reported safety data so far, the company aims to submit an application to regulatory authorities by the end of 2017 for a Phase 2, randomized, placebo-controlled clinical study on Lymfactin®. The company has initiated discussions on a Phase 2 study with regulatory authorities and study centers.
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 intention is to recruit a total of 15 patients in the clinical study by the end of 2017.
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 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 a gene therapy expressing the growth factor VEGF-C specific to 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. 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 for breakthrough in unmet clinical needs. Our first-in-class assets are based on globally leading scientific research in their fields: CDNF for disease modification in neurodegenerative diseases, primarily Parkinson's and ALS; and Lymfactin® for 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.