On December 17, 2019 Herantis Pharma Plc ("Herantis" or "Company") reported that patient recruitment in the Company’s Phase 2 clinical trial AdeLE ("Adenoviral gene therapy for the treatment of LymphEdema") has been completed (Press release, Herantis Pharma, DEC 17, 2019, View Source [SID1234552451]). All of the 39 patients with breast cancer associated lymphedema have been randomized to receive either Lymfactin or placebo treatment, and their treatments have been completed according to the study protocol. The AdeLE trial will continue with a 12-month blinded follow-up to evaluate the safety and efficacy of Lymfactin in the treatment of breast cancer associated lymphedema, when combined with a conventional lymph node transplantation surgery. Herantis expects to unblind the study and announce its top-line results in the first quarter of 2021.

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"The rapid enrolment completion demonstrates not only that there is a significant need for novel treatment options in lymphedema, but it is also an important milestone for our Lymfactin program as we are advancing into late-stage clinical development. We are truly grateful to the patients who participated in the AdeLE study, the supporting physicians and staff at the study sites, and to the international patient organization LE&RN, which fights to raise awareness for lymphedema as a significant unmet clinical need," commented Pekka Simula, CEO of Herantis. "Based on the cumulated safety data and assessments of the trial’s independent Data Safety Monitoring Board, we are encouraged by the established safety profile of Lymfactin. We look forward to the efficacy read-outs that could bring new hope to lymphedema patients all around the world."

Study Design

The AdeLE study is a multi-center, randomized, double-blind, placebo-controlled Phase 2 trial that evaluates the safety and efficacy of Lymfactin in the treatment of breast cancer associated lymphedema, when combined with a conventional lymph node transplantation surgery. In total, 39 patients with breast cancer associated lymphedema have been recruited in the study and randomized 1:1 to receive a single dose of either Lymfactin or placebo as an adjunct to surgery. The active patient treatment period was completed with last dosing in December 2019 and the study continues with a 12-month blinded follow-up.

Study Objectives

The primary endpoint of the AdeLE study is efficacy in the treatment of breast cancer associated lymphedema. Efficacy will be assessed by changes in the volume of the affected arm compared with the unaffected arm, quality of life of the patient based on the Lymphedema Quality of Life Inventory and the assessment of the lymph flow of the affected arm by quantitative lymphoscintigraphy.

Further Information:

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 Lymfactin

Lymfactin is the world’s first and only clinical stage gene therapy that repairs damages of the lymphatic system. It expresses the human growth factor VEGF-C, which is naturally associated with the development of lymphatic vessels. Based on preclinical studies, Lymfactin triggers the growth of new functional lymphatic vasculature in the injured area and thus repairs the underlying cause of secondary lymphedema. The first target indication for Lymfactin is Breast Cancer Associated Lymphedema; Herantis believes that Lymfactin may also be suitable for the treatment of other forms of secondary lymphedema if its safety and efficacy are established in the first indication. Based on cumulated data from a Phase 1 clinical study in 15 patients with breast cancer associated lymphedema, Lymfactin is safe and well tolerated. The efficacy of Lymfactin is currently studied in the Phase 2 clinical study AdeLE in Finland and Sweden.

Lymfactin, patented by Herantis, is based on the internationally renowned scientific research of academy professor Kari Alitalo and his research group, a national center of excellence at the University of Helsinki. For more information please see View Source

About Breast Cancer Associated Lymphedema

Approximately 20% of breast cancer patients who undergo axillary lymph node dissection develop secondary lymphedema: a 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 address the underlying cause of lymphedema, which results from damage to the lymphatic system. There are currently no approved medicines for the treatment of secondary lymphedema.