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Lymfactin® aims to become the first drug for treating secondary lymphedema

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Lymfactin® aims to become the first drug for treating secondary lymphedema

Lymfactin® is currently in a randomized, double-blind, placebo-controlled, multi center, Phase 2 clinical study in Finland and Sweden in patients suffering from breast cancer associated secondary lymphedema.

About Lymfactin®

Lymfactin® is based on the scientific discovery of VEGF-C, the natural human protein necessary for the growth of new lymphatic vessels. Lymfactin® is a gene therapy, which delivers the human gene coding for VEGF-C and thereby promotes the formation of new lymphatic vessels. Lymfactin® is administered locally at the site with injuries in the lymphatic system with the aim of repairing those injuries. In disease models, this local VEGF-C expression, which lasts for about two weeks, has resulted in the formation of new lymphatic vessels. This may eventually normalize the lymphatic flow and thereby stop the accumulation of the lymph in the patient’s tissue. If Lymfactin® works in human patients as well as it has worked in disease models, it can lead to a significant breakthrough in the treatment of secondary lymphedema. VEGF-C was discovered by Professor Kari Alitalo and his research group at the University of Helsinki.

Lymfactin® mode-of-action

Lymfactin® Clinical Development Status

Lymfactin® is presently being developed for the treatment of breast cancer associated secondary lymphedema (BCAL) in patients who undergo lymph node transplantation surgery. A Phase 1 clinical study is currently in a long-term follow-up and a Phase 2 clinical study is currently ongoing. The patient recruitment has been completed.

The ongoing Phase 2 clinical study is a multi-center, randomized, double-blind, placebo-controlled study. The study is planned to enroll about 40 patients in Finland and Sweden at five university hospitals in Uppsala, Stockholm, Helsinki, Tampere, and Turku. The Phase 2 study will assess the efficacy, safety, and tolerability of Lymfactin®. Half of the patients will receive one dose of Lymfactin® and half will receive placebo in combination with the lymph node transplantation surgery. The efficacy endpoints include the volume measurement of the affected vs. non-affected limb prior and after the treatment, lymphoscintigraphy prior vs. after the treatment for assessing the functionality of the lymphatic system, and the assessment of quality-of-life. More information about the ongoing clinical study is found at www.lymfactin.eu.

The Phase 1 clinical study recruited 15 patients from 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 the one-year follow-up. The higher dose was selected for the Phase 2 clinical study. The Phase 1 study continues with a long-term follow-up on all patients. In the Phase 1 study, there was no control group and, thus, no conclusions of the efficacy of the Lymfactin® treatment can be made based on the Phase 1 data.

About Secondary Lymphedema

Secondary lymphedema is caused by local injuries of the lymphatic system, which can manifest as a result of cancer treatments such as surgery and radiotherapy. The injuries of the lymphatic system may disrupt the normal flow of lymph, which will then start to accumulate in tissue, for instance in a limb. This results in chronic, progressive swelling.

Secondary lymphedema is a painful, deforming disease that often has a significant impact on the quality of life of the patients. Symptoms of secondary lymphedema include progressive swelling of the affected limb, pain, decreased mobility, and increased forming of connective tissue. Many patients also suffer from repeated infections of the affected tissue. Patients are often ashamed of their deformed appearance and may fail to seek appropriate treatment.

According to the global patient organization, LE&RN, misdiagnosis is common. Patients or even their treating oncologists or physicians may not know they are suffering from a disease.

A curative treatment for lymphedema is not known. Depending on the case, the symptoms of LE can be alleviated by physiotherapy or massage. Many patients who have lymphedema of the arm wear a compression garment. These kinds of treatments do not repair injuries of the lymphatic system, which cause the disease. Surgical procedures such as lymph node transplantation, lymphaticovenous anastomosis, and lymphaticolymphatic bypass are also used.

Based on published cancer incident data we estimate that about 30,000 breast cancer associated secondary lymphedema cases are diagnosed annually in the USA and Europe. Secondary lymphedema is also associated with other cancers including melanoma, gynaecologic cancers, and genitourinary cancers resulting in estimated 150,000 secondary lymphedema cases in the USA and Europe. In the USA it has been estimated that the treatment of breast cancer associated secondary lymphedema costs over 10,000 USD a year per patient.

Selected publications

Tervala TV, Hartiala P, Tammela T, Visuri MT, Ylä-Herttuala S, Alitalo K, Saarikko AM. Growth factor therapy and lymph node graft for lymphedema. J. Surg. Res. 196(1): 200-7, 2015.

Lähteenvuo M, Honkonen K, Tervala T, Tammela T, Suominen E, Lähteenvuo J, Kholová I, Alitalo K, Ylä-Herttuala S, Saaristo A. Growth factor therapy and autologous lymph node transfer in lymphedema. Circulation 123: 613-20, 2011.

 

Thanks to the following link: https://herantis.com/pipeline/#lymfactinsupsup

Autor: monica boersch

Vor ein paar Jahre bin ich an Krebs erkrankt, bedingt durch meine Wertheim OP, Bestrahlung und Afterloading habe ich Lymphödeme bekommen, für mich sehr überraschend da ein paar Jahre dazwischen lagen, ich wusste das etwas nicht stimmt aber leider konnten unzählige Ärzte nicht helfen. Hier ist es auch so, wie in viele viele andere Länder auch, dass Lymphatische Erkrankungen erstens nicht wirklich ernst genommen werden und zweitens das kaum ein Arzt darüber Bescheid weiß, wie den auch, wenn in den Lehrbüchern so gut wie NICHTS steht. Mein Bestreben ist alles zu tun was in meiner Macht steht um dafür zu sorgen das jeder der betroffen ist weiß was er/ sie tun kann um sein Leben wieder so gestalten zu können wie er/sie das möchte. . Ich suche und suche immer weiter nach alternativ Möglichkeiten um meinen Leben so normal wie möglich zu gestalten. Die Empfehlungen die ich gebe sind bei mir durchaus wirksam und ich erziele gute Erfolge und behalte meine Lebensqualität. Mein Blog ist kein Ersatz für eine Ärztliche Betreuung und ich empfehle jeden mit seinem Arzt über Therapie Möglichkeiten etc. zu sprechen. Ich kann nur anregen und durch meine eigene, persönliche Erfahrung eventuell einen weg aufzeigen. Seit 2009 beschäftige ich mich weit über das übliche hinaus mit Lymphödeme. Nicht nur die „Diagnose“ interessiert mich, sondern ebenso was für einen Effekt es hat auf unser Sozialleben und unser Selbstwertgefühl. Ich habe viel Zeit und Geld investiert in andere Länder zu reisen um alternativen kennenzulernen, ich war bei Internationale Firmen als Gast um zu sehen welche Lösungen geboten werden, habe fast jeden Lymphologischen Kongress besucht um mich weiter zu bilden und einige Projekte als Freelancer machen können. Wie ihr sieht ist das weitaus mehr als nur ein Blog, es müssen sich grundliegende Dinge verändern um uns alle das zu geben was wir verdienen, Respekt, Empathie und das Bewusstsein das wir nichts Vorübergehendes haben, sondern das dieses ein Teil unseres Lebens ist und auch bleibt. After being diagnosed with Cancer and going through treatments, Wertheim operation, radiation therapy and afterloading I was suddenly hit by Lymphedema. Totally surprising since nobody even gave me a hint that this could happen. Running from one doctor to the other trying to find out what is wrong with me and why my body was changing so quickly, once again being in the situation of not having control of anything. This made me so angry that I started studying like crazy, I wanted to find out why we are left alone, why doctors don’t have a clue (sorry, most doctors) about Lymphedema and the consequences in all aspects of our lives. Sadly, I had to realize that hardly anyone knows anything about it. I started my quest to find alternatives in treatments, I traveled around the world investing my time and money, fortunate enough to spend time in companies specialized in Lymphedema treatment to learn all that I could and can. I hardly miss any Lymphatic congress, listening to the internationally known doctors, discussing what is important for us as patients. I have done some freelance work for the companies that I believe in and had the chance to work with a wonderful company in New Jersey. I have tested alternatives and I am still searching and studying because it is my quest to change things for all affected by this, not only our physical wellbeing but most importantly the impact that it has on our daily life. It’s not something that’s going to go away, it’s with us until the end and the minimum that we can expect is being taken seriously, respect and empathy for our situation and the importance for all of us that have the possibilities to change things for the better. There is so much work to do, and I am not going to give up. As you can see this is more than a blog. If you find something interesting on Lymphfantastic but you are having problems with the German, then just send me a message and I will be happy to translate that for you, my native language is English so that is no problem. Have a great day and looking forward to hearing from you soon. Bless you all, Monica

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