I had contact from a fellow “lymphie” who also happens to be a research scientist and she has passed on to me some of the latest research and updates. Some of these studies could still be years in the pipeline but for me I think it is great that money and time is being put into research to find a cure for lymphoedema. Some of you may have heard of Lymfactin which is a virus that delivers epidermal growth factor to the Flap of tissue containing the nodes to be transferred. This increases the success rate of transfer and promotes lymphatic growth, as well as venous growth. It is in clinical trial stage 1 at Stanford University after being developed in Finland. Small studies so far have on animals have had good outcomes and a company has been set up to produce Lymfactin commercially. Human trials are due to start this year, research is needed especially the long-term effects. There is a concern re cancer, as it is a growth factor and given that many patients have secondary Lymphoedema as a result of cancer, this then becomes a very real risk in case of abnormal changes. The belief is that the doses are very small and should therefore not cause harm.
Some of the studies on animals have shown amazing results in that one node has been used and divided, growth factor has then been used as the fragments of nodes are transferred and some of the fragments have been shown to grow. So in theory it is possible for one node to give rise to multiple new nodes, the combination of divided nodes and Lymfactin gives rise to some fantastic possibilities especially for Primary Lymphoedema when there are so few nodes available. Commercially lymfactin is still a years away as FDA approval has to pass through three stages usually it at least five years but could be much longer.
Thank you Tracy for passing this info on to me and helping me to understand the whole process.. At least we are seeing work being done to improve future outcomes for those with Lymphoedema..
Professor Kari Alitalo of the University of Helsinki, who made the discovery that the growth factor VEGF-C regulates the growth and development of the lymphatic system in humans and other mammals, presented the findings. From this discovery and in association with his co-workers Dr. Tuomas Tammela and Dr. Anne Saaristo, they identified that if VEGF-C is injected into tissues in mice and subsequently in pigs, growth of new lymphatic vessels and the restoration of the lymphatic architecture is catalyzed. Previous studies have shown that transferring lymph nodes from the inguinal region to the axillary region in patients with secondary lymphedema following their treatment for breast cancer was found to offer a slight improvement in their condition. Removal of old scar tissue from the axilla is considered an important step of this procedure.
The team in Finland then went a step further and showed that by combining VEGF-C injections with lymph node transfer in animal models using mice and then pigs, the response seen was even better than lymph node transfer alone. The results in mice indicated that lymphedema treated with lymph node transfer alone resulted in about 20% improvement. However, when combined with the administration of VEGF-C, the overall response was increased to around 80%.
In collaboration with Dr. Rockson, Dr. Anne Saaristo, MD and Prof. Kari Alitalo, Laurantis researchers, are developing a treatment to potentianlly enable much higher transfer success. The Company plans to start a phase I/II study in patients with breast cancer associated lymphedema in early 2013. Lymfactin is an investigational therapy and has not been approved by the U.S. Food and Drug Administration. Excerpt http://www.marketwire.com/press-release/research-team-discovers-four-fold-improvement-ability-restore-lymphatic-function-with-1628749.htm
Laurantis Pharma and Ark Therapeutics Sign Manufacturing Agreement for Production of Lymfactin™ Investigational Treatment for Breast Cancer-Associated Lymphedema
LONDON and TURKU, FINLAND–(Marketwire – Oct 15, 2012) – Ark Therapeutics has been selected to manufacture and supply Lymfactin™ to Laurantis Pharma under a conditional agreement announced today by the Finland-based companies. The agreement is subject to Laurantis receiving regulatory approval to commence its phase I clinical trial. Specific terms of the agreement are not disclosed. Lymfactin™ uses an adenoviral vector to deliver vascular endothelial growth factor (VEGF-C) during transplantation of lymph nodes in order to avoid lymphedema.
The phase I clinical trial using Lymfactin™ to treat breast cancer-associated lymphedema is targeted to begin in 2013, and will recruit patients in the USA and Finland. Breast cancer-associated lymphedema is the most common form of secondary lymphedema, occurring in approximately 20% of breast cancer patients who undergo axillary lymph node dissection. The incidence is even higher in those who also receive radiotherapy, and this complication may even occur in those who undergo a lymph node biopsy as part of treatment. No therapeutic treatment currently exists to treat this disease.
In the US, approximately 110,000 patients are living with breast cancer-associated lymphedema, and nearly 15,000 new patients develop the complication each year. The number of lymphedema patients in Europe is estimated to be roughly the same as in the US.
About Laurantis Pharma Oy
Based in Turku, Finland, Laurantis is a privately held clinical-stage biotechnology company with a broad portfolio of first-in-class products based on two proprietary technologies. The Company’s pipeline includes proprietary and patent-protected formulations and applications of cis-urocanic acid, a locally acting anti-inflammatory and anti-proliferative agent for the treatment of Atopic Dermatitis, Dry Eye, Interstitial Cystitis, and Bladder Cancer. Laurantis is also developing Lymfactin™, a vascular endothelial growth factor C (VEGF-C) in an adenoviral vector, as a gene therapy product for the treatment of secondary lymphedema. Excerpt from http://www.marketwire.com/press-release/laurantis-pharma-ark-therapeutics-sign-manufacturing-agreement-production-lymfactin-lse-akt-1713211.htm