Celltaxis LLC is a clinical stage company developing the investigational drug Acebilustat. Acebilustat, is a novel synthetic small molecule leukotriene A4 hydrolase (LTA4H) inhibitor being developed for the treatment of conditions involving dysregulated immune response, such as Lymphedema. Acebilustat may limit the pathogenesis of Lymphedema and enhance lymphatic repair offering an effective treatment for a debilitating disease currently in need of therapeutic solutions.
We are currently conducting a Phase II, open label, Lymphedema trial with Acebilustat. Previously, Acebilustat has been evaluated in several Phase I and II studies for other indications, and has demonstrated a favorable safety, tolerability and PK profile.
We believe that Acebilustat, a potent immune system modulating investigational drug, when taken orally once a day, may help reduce the inflammatory pathology and abnormal skin thickening of lymphedema.
Arm Lymphedema is a debilitating chronic condition that can arise after cancer treatment or after other forms of lymphatic injury or abnormal lymphatic development. It occurs when impaired fluid transport through the lymphatic circulation leads to non-resolving progressive fluid retention, resulting in increasing limb girth, fibrosis, inflammation, abnormal fat deposition and skin changes. At present, there is no definitive drug treatment for lymphedema.
Acebilustat for Arm Lymphedema is under investigation in a Phase II clinical trial at Stanford University, a LE&RN-designated Center of Excellence, led by Dr. Stanley G. Rockson. Additional studies of Acebilustat for other aspects of Lymphedema, including lymphedema of the trunk and legs, are in the planning stages.
Participation in the Acebilustat Phase II “HEAL" Study
Celltaxis is pleased to announce that our Phase II Trial of Acebilustat for the Treatment of Upper Arm Lymphedema (HEAL) is underway at Stanford University. We hope to determine if oral administration of Acebilustat will improve the skin manifestations of chronic unilateral upper extremity Lymphedema.
Arm Lymphedema is a debilitating chronic condition often secondary to Breast Cancer, with no definitive curative treatment. It occurs when impaired fluid transport through the lymphatic circulation leads to non-resolving progressive fluid retention, resulting in increasing limb girth, fibrosis, inflammation abnormal fat deposition and skin changes.
• Participants age 18-75 are eligible
• With unilateral Stage II chronic lymphedema of the arm.
• Unaffected limb volume ratio of > 1.2 and duration of > 6 months
• The Study is 9 months long with ~ 5 site visits
If interested please contact:
Stanley Rockson, MD
Falk Cardiovascular Research Center
300 Pasteur Dr, CVRC 261
Stanford, CA 94305 5406
650 725 7571 (office); 650 725 1599 (fax)