Breast cancer patients may suffer from lymphedema, a severe swelling of an upper limb caused by axillary lymph node dissection or radiation therapy.
Lymfactin® is a drug candidate, which is currently being developed for the treatment of lymphedema (LE). Clinical studies will assess the safety and efficacy of Lymfactin® for the treatment of breast cancer associated secondary lymphedema (BCAL) when combined with a conventional surgical treatment, lymph node transplantation.
Lymfactin® has already been studied in a Phase 1 clinical study, a Phase 2 study is fully recruited
Lymfactin® has been studied in a Phase 1 clinical study in Finland. In total 15 patients participated in that study in which the first three patients received a lower and the last 12 patients a higher dose of Lymfactin®. Both doses were safe and well tolerated based on a one-year follow-up. The Phase 1 study continues with a long-term follow-up on all patients.
A randomized, placebo-controlled Phase 2 study has been fully recruited. The study continues with patient follow-up for 12 months for all patients after which the study will be unblinded to analyze the results. The Phase 2 study will continue thereafter with long-term patient follow-up with safety and efficacy related assessments. The Lymfactin® dose in the Phase 2 clinical study was the same as the higher dose in the Phase 1 study, which was concluded safe.
Lymfactin® is based on a natural human growth factor
Lymfactin® represents a novel class of drug compounds: it is a gene therapy, which means that a specific gene is delivered to the patient to treat a disease. In the case of Lymfactin® the transferred gene, also called transgene, exists also naturally in the human body. The transgene in Lymfactin® codes for a natural human growth factor, VEGF-C (vascular endothelial growth factor C), which is necessary for the growth of lymphatic vessels. Lymfactin® administration results in a temporary local expression of VEGF-C for about 2-3 weeks. A treatment with Lymfactin® does not change the genome of the patient. Lymfactin® is based on the internationally renowned scientific research at a national center of excellence lead by professor Kari Alitalo at the University of Helsinki.
Based on preclinical research studies, Lymfactin® dosing results in the formation of new functional lymphatic vessels. It thus repairs the damages that cause secondary lymphedema.
Please see the video below for more details on the mechanisms of Lymfactin®.
Lymfactin® gene therapy is based on the natural and common adenovirus, which has been modified to render it incapable of replication and thus unable to cause an infection typically associated with an adenovirus, such as a respiratory infection (common cold). The human gene coding for the growth factor VEGF-C has been added in the adenoviral genome using gene technology.
Drug compounds that are based on the adenovirus have been developed for decades and investigated in hundreds of clinical studies. Adenovirus-based drugs are not routinely used in Europe or USA and their possible long-term impacts are not yet known.