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FDA grants orphan drug designation to Cellspan esophageal implant
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The FDA has issued orphan drug designation to Biostage’s Cellspan esophageal implant, which restores the structure and function of the esophagus following damage related to cancer, injury or congenital abnormalities, the company announced.
“The orphan drug designation for our Cellspan esophageal implant is an important achievement in our regulatory strategy as we advance this novel product candidate that we believe has the opportunity to create a significant treatment paradigm shift in regenerative medicine,” Jim McGorry, CEO of Biostage, said in the press release. “Based on preclinical, large-animal studies conducted to date, we believe our Cellspan esophageal implants may have the potential to offer improved outcomes for patients by reducing post-operative complications and providing an improved quality of life, by prompting regeneration of the patient’s own esophagus.”
The Cellspan esophageal implants use Biostage’s Cellframe technology, which uses the patient’s own stem cells to regenerate tissue and restore function of the esophagus.
“This technology is based on the concept of in situ tissue regeneration using the body’s own biologic resources and reparative capability in combination with tissue-specific biomaterials implanted at the sites of disease or injury,” according to the press release. The implants “are intended to offer numerous advantages over standard surgical resection including: eliminating the use of the stomach or intestine to create a mock esophagus, reduced complications and improve post-surgical morbidity.”
The company plans to file an Investigational New Drug application and begin phase 1 human clinical studies in the third and fourth quarters of 2017, respectively.
Orphan designation is issued to drugs and biologics that treat rare diseases or disorders that affect fewer than 200,000 Americans, or for those that are not expected to recover development and marketing costs. This status provides 7-years marketing exclusivity against competition upon approval, and other incentives.
Disclosures: McGorry is employed by Biostage.