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Biostage Announces IND Approval from FDA for its Lead Product Candidate Cellspan Esophageal Implant
March 25, 2020
Biostage, Inc., a bioengineering company developing next-generation esophageal implants, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug application (IND) for the Cellspan Esophageal Implant (CEI) to treat patients with end-stage esophageal disease that require a segmental surgical resection to repair the diseased tissue. The FDA notified the Company that it removed the clinical hold and that the Company may proceed with its study.
“FDA’s approval of Biostage’s first IND is an extremely important milestone for Biostage as it will transition Biostage into a clinical stage company. In addition, establishing a safety profile for the CEI in adults will facilitate and support the use of the CEI in Esophageal Atresia patients. Esophageal Atresia (EA) is a congenital condition in infants who are born with an incomplete esophagus and are unable to receive oral nutrition. We believe the CEI will be a significant advancement for EA and will provide a treatment option that will hopefully change the standard of care for these infants,” said Jason Jing Chen, Biostage’s Chairman. “Further, this IND approval is a very vital corporate milestone and a critical step forward to achieving a strategic partnering arrangement and/or capital funding. We are confident that the industry will recognize the tremendous value and the advancement in tissue engineering and cell-based therapies that the CEI product represents. I would especially thank Dr. William Fodor, our CSO and the Biostage team who managed the interactions with the FDA and the substantial and timely responses to the Agency. The team dedicated themselves to accomplishing this goal. Many long hours and weekends went into this IND submission to ensure that the FDA received the highest quality document possible.”
The approved IND will investigate the safety and feasibility of the CEI in adult patients. The study will be an unblinded single arm study in patients that require surgical resection of the esophagus. The CEI will be implanted into the resected esophagus vs. complete esophagectomy, which essentially removes the entire esophagus and replaces it with either a section of the colon or with a portion of the stomach that has been reconstructed. “The use of the CEI is an organ sparing approach that preserves the esophagus while treating conditions that would otherwise require the use of other organs to repair the diseased tissue,” commented Dr. William Fodor, Chief Scientific Officer of Biostage.
“Our next goal is focused on ‘clinical readiness’ and to build upon our expertise in the clinical application of tissue engineered and cell-based products”‘ stated Dr. Fodor. ‘This is an exciting time for Biostage to establish itself as a leader in the clinical application of regenerative medicinal products, such as the CEI, where the product provides the stimulus and the foundation for the body to heal itself.”
Written by: Biostage, Inc.
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