First Patient Dosed in Secondary Lymphedema Study
Published Online: Monday, Jul 25, 2016
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Eiger BioPharmceuticals dosed the first patient in the Phase 2 Ultra Study of their drug Ubenimex in patients diagnosed with secondary lymphedema. The Ultra study is designed to assess the effectiveness of ubenimex blocking the production of Leukotriene B4 (LTB4).
The study will evaluate the effects of ubenimex in patients with secondary lymphedema of the lower limb(s) who are optimized on physical therapies. The Ultra Study is a multi-center, randomized, double-blind, placebo-controlled Phase 2 trial assessing 40 patients that will be randomized to receive either 150 mg of ubenimex or placebo three times a day over 24 weeks.
Leukotriene B4 (LTB4) is a naturally-occurring inflammatory substance known to be elevated in both preclinical models of secondary lymphedema as well as human lymphedema disease. Elevated LTB4 causes tissue inflammation and impaired lymphatic function. Targeted pharmacologic inhibition of LTB4 promotes lymphatic repair and reverses lymphedema disease in treated animals.
Ubenimex is an oral, small-molecule inhibitor of leukotriene A4 hydrolase, which regulates the production of leukotriene B4 (LTB4), an inflammatory mediator implicated in PAH. LTB4 is produced from leukocytes in response to inflammatory mediators and is able to induce the adhesion and activation of leukocytes on the endothelium, allowing them to bind to and cross it into the tissue.
Ubenimex is also currently being evaluated in a Phase 2 study for the treatment of Pulmonary Arterial Hypertension (PAH).
Secondary lymphedema usually develops as a result of a lymph vessel blockage or interruption that alters the flow of lymph through the lymphatic system and can develop from an infection, malignancy, surgery, scar tissue formation, trauma, radiation, or other cancer treatment Radiation therapy can damage otherwise healthy lymph nodes and vessels, and can cause scarring of the lymphatic vessels which leads to fibrosis and subsequently diminish lymphatic flow.
Always excited to see any research into treating and curing Lymphedema …