Procedure was approved via the FDA’s single-use expanded access program and was performed at a major U.S. hospital.
HOLLISTON, Mass., Aug. 7, 2017 /PRNewswire/ — Biostage Inc., (Nasdaq: BSTG), (“Biostage” or the “Company”), a biotechnology company developing bioengineered organ implants to treat cancer, congenital abnormalities and other life-threatening conditions of the esophagus, bronchus and trachea, today announced the use of Biostage’s Cellspan Esophageal Implant product candidate in a patient at a major U.S. hospital via an FDA-approved single-use expanded access application.
On May 4, 2017, the Cellspan Esophageal Implant was surgically implanted into a 75-year old male with a life-threatening cancerous mass in his chest. The surgery was required to address the tumor’s encroachment on the patient’s lung, heart, and esophagus. The portion of the esophagus affected by the cancer was removed and the Cellspan Esophageal Implant was utilized to reconstruct the esophagus. The patient is now alive three months after surgery. Biostage believes that the Cellspan Esophageal Implant has performed as designed.
Within a collaborative agreement between Biostage and The University of Texas Health Science Center at Houston(UTHealth), the patient’s own stem cells were processed, seeded and grown onto the scaffold at the Cellular Therapy Core of the Program in Children’s Regenerative Medicine at UTHealth, prior to release for transport to the institution carrying out the surgery.
Saverio La Francesca, M.D., President and Chief Medical Officer of Biostage, stated, “We are encouraged by the ongoing success of the Cellspan Esophageal Implant in our first in-patient case, and we look forward to additional opportunities to provide an alternative solution to patients in need of an esophageal replacement. Our large-animal preclinical data has been promising, so we are invigorated by the apparent reaffirmation of the regenerative properties of our technology and the clinical benefits in this extremely complex case.”
Jim McGorry, CEO of Biostage, commented, “The Cellspan Esophageal Implant has the potential to significantly improve quality of life for a patient who has undergone an esophageal resection, as it improves upon the current standard of care for the treatment of esophageal cancer. Regeneration of the esophagus in a high-risk patient and under extremely trying conditions, such as evidenced to date in this case, indicates that the regenerative properties of the implant may be reproducible in other patients.”
About Cellspan™ Esophageal Implants
Cellspan Esophageal Implants utilize the Company’s proprietary Cellframe technology and may offer improved outcomes for patients by potentially simplifying surgical techniques to reduce post-operative complications and improve quality of life, by prompting regrowth of the patient’s own esophagus. Cellspan 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 improved post-surgical morbidity.
Biostage is a biotechnology company developing bioengineered organ implants based on the Company’s new Cellframe™ technology which combines a proprietary biocompatible scaffold with a patient’s own stem cells to create Cellspan organ implants. Cellspan implants are being developed to treat life-threatening conditions of the esophagus, bronchus or trachea with the hope of dramatically improving the treatment paradigm for patients. Based on its preclinical data, Biostage has selected life-threatening conditions of the esophagus as the initial clinical application of its technology.
Cellspan implants are currently being advanced and tested in collaborative preclinical studies. Preclinical, large-animal safety studies, conducted in compliance with the FDA Good Laboratory Practice (“GLP”) regulations, for the Company’s Cellspan Esophageal Implant product candidate are ongoing, in support of Biostage’s goal of filing an Investigational New Drug application (“IND”) with the U.S. FDA in the third quarter of 2017. Upon IND approval, the Company plans to initiate its first-in-human clinical trials for its esophageal implant product candidate by the end of 2017.
For more information, please visit www.biostage.com.
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SOURCE: Biostage Inc.