Regenerative medicine company Tengion (NASDAQ:TNGN) has been granted orphan drug designation on its technology that is initially being developed to help patients with bladder cancer.
Tengion’s platform technology for organ regeneration can create organs and tissues that the body will recognize as its own. The technology is intended to offer an alternative to current practices of using tissue from one part of the body to replace tissue in another, which can cause complications. It could also be an alternative to organ donation, which requires anti-rejection medicines.
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Tengion’s first application target is helping bladder cancer patients who have had their bladders removed. The technology isn’t being used to develop a new bladder. Rather, the technology is used to make functional tissue that can form a conduit that diverts urine from the ureters to a removable, disposable bag outside the body. Patients who have their bladders removed currently have such conduits created from their bowel tissues, which raises several complications. Tengion’s tissue generation technology is in a phase 1 clinical trial. You can watch a video of construction of a conduit here.
Orphan drug status provides incentives for companies to develop products to address rare, unmet medical needs that affect fewer than 200,000 patients in the United States. The U.S. Food and Drug Administration’s orphan drug designation for Tengion’s Neo-Urinary Conduit would give the company seven years of U.S. marketing exclusivity if it receives regulatory approval. The company could also get tax credits for clinical research expenses and a waiver of some FDA fees.
Tengion is headquartered in Pennsylvania, but the company has most of its employees in Winston-Salem, North Carolina, where it maintains its R&D operations. Tengion was spun out of Wake Forest University based on the research of Dr. Anthony Atala, director of the Wake Forest Institute for Regenerative Medicine.
