Herantis Pharma initiates patient recruitment for clinical study with Lymfactin® in breast cancer associated lymphedema
Herantis Pharma Plc
Company release 18 May 2016 at 9:00 am
Herantis Pharma Plc ("Herantis") has started patient recruitment for its clinical study with Lymfactin® for the treatment of breast cancer associated secondary lymphedema. While the primary endpoint of the study is to assess the safety and tolerability of Lymfactin® the study will also assess the preliminary efficacy of the treatment.
"Lymfactin® is a prime example of regenerative medicine", explains Burkhard Blank, MD, Chief Medical Officer of Herantis. "A human growth factor is harnessed for its natural purpose: To trigger the growth of new lymphatic vessels to repair the underlying cause of lymphedema. As of today an efficacious treatment of lymphedema is not known."
"General awareness of lymphedema has increased significantly thanks to the amazing work by Hollywood actress Kathy Bates and other brave patients", adds Pekka Simula, Herantis' CEO. "This huge unmet clinical need is acknowledged even by the U.S. Senate. There is a will; we have strong faith that Lymfactin® can provide the way by being the first efficacious treatment to this disabling and disfiguring condition, which severely affects the quality-of-life of patients. Our clinical study will also mark the first time in the world when gene therapy is applied to repairing damage of the human lymphatic system."
The Phase 1 clinical study is now recruiting patients with breast cancer associated lymphedema at the Helsinki University Central Hospital in Finland. Two further study sites in Finland are planned for opening later this year. The study intends to recruit at most 18 patients, and recruitment is expected to be completed in 2017.
Herantis Pharma Plc, Pekka Simula, CEO, telephone: +358 40 7300 445
Herantis Pharma Plc, Katarina Jääskeläinen, Project Manager, telephone +358 50 3055 582
Company web site: www.herantis.com
Certified Advisor: UB Securities Ltd, telephone: +358 9 25 380 246
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 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 an adenovirus-based gene therapy expressing the growth factor VEGF-C specific to the development of lymphatic vessels. Based on preclinical studies it is expected to trigger the growth of new functional lymphatic vasculature in the damaged area and thus repair the underlying cause of lymphedema. Lymfactin®, patented by Herantis, is based on the internationally renowned scientific research of academy professor Kari Alitalo and his research group at the University of Helsinki. Herantis also holds patents for a combination therapy, which may expand the use of Lymfactin® in primary lymphedema.
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. The scope and duration of a drug development program varies depending on the target indication, type of the investigational medicinal product, and other factors.
About Herantis Pharma Plc
Herantis Pharma Plc is a drug development company focused on early clinical development of innovative drugs in unmet clinical needs. Our special emphasis is in regenerative medicine where the company has two first-in-class assets based on globally leading science in their fields: CDNF for neurodegenerative diseases, primarily Parkinson's and ALS; and Lymfactin® for breast cancer associated lymphedema, with potential also in primary lymphedema. The shares of Herantis are listed on the First North Finland marketplace run by Nasdaq Helsinki stock exchange.