t2cure’s Cellular Therapeutic Receives Orphan Drug Designation from FDA, EMA Recommendation for Buerger’s Disease
t2cure GmbH announced that the FDA has granted Orphan Drug Designation to t2c001 for the treatment of Buerger’s Disease. The Company also announced that in a concurrent application in Europe the EMA’s Committee for Orphan Medicinal Products recently recommended t2c001 for orphan designation to the European Commission.
Buerger’s Disease, or thromboangiitis obliterans, is a rare and severe disease affecting the blood vessels of the legs and arms. It is characterized by inflammation and occlusion of the vessels of extremities resulting in reduced blood flow to these areas, thus leading to severe pain and ulcers or necrosis, which finally may require amputation. t2c001 is an autologous cellular therapeutic, consisting of stem cells derived from the patient’s own bone marrow. The treatment is designed to enhance the body’s limited capability to restore blood flow in ischemic tissue by improving neovascularization.
“The orphan drug status for t2c001 in Buerger’s Disease is an important milestone, as it provides market exclusivity for 7 years in the United States and 10 years in Europe, thereby significantly increasing the commercial potential of this groundbreaking therapy”, commented Dr. Petra Rueck, CEO of t2cure.
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