Herantis Pharma completes patient enrolment in Phase 1 study of Lymfactin gene therapy for secondary lymphedema and has submitted Phase 2 application

February 8, 2018 I Herantis Pharma Plc ("Herantis") has completed the patient enrolment in the clinical Phase 1 safety and tolerability study with the company's investigational gene therapy product Lymfactin® for the treatment of breast cancer associated secondary lymphedema. The company intends to proceed rapidly to a randomized, placebo-controlled Phase 2 study of Lymfactin® in the same indication and has already submitted the clinical trial application to the regulatory authorities.

"Thanks to the highly skilled teams of the three participating university hospitals, the first-in-human clinical study of Lymfactin® has proceeded as expected", comments Katarina Jääskeläinen, Herantis' Project Manager. "Based on favorable safety data from Phase 1 we are preparing for a rapid move to Phase 2 in Lymfactin® development."

"We are very grateful to the patients who by enrolling in this study help advance the development of a potential novel therapy for the treatment of lymphedema", adds Pekka Simula, Herantis' CEO. "Lymphedema causes suffering in millions of patients. Lymfactin®, based on leading science, could make a significant improvement in its treatment."

The Phase 1 study recruited in total 15 patients with breast cancer associated lymphedema. The study continues with a 12-month follow-up on the patients.

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.

About Lymfactin®

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. Initial 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 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.

SOURCE: Herantis Pharma

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