Biostage, Inc. (NASDAQ: BSTG) is trading 30% higher following news that the company’s Cellspan™ Esophageal Implant was granted Orphan Drug Designation to restore the structure and function of the esophagus subsequent to esophageal damage due to cancer, injury or congenital abnormalities. This designation provides for a seven-year marketing exclusivity period against competition upon marketing approval, as well as certain incentives, including tax credits and a waiver of PDUFA filing fees. Biostage said it expects to file its IND in the third quarter of 2017 followed by its phase 1 first-in-human clinical study in the fourth quarter of 2017. “We believe this Orphan Drug Designation and the regulatory guidance we recently received from the FDA, provide a clear development pathway which may potentially enable us to offer a promising treatment outcome for patients suffering from esophageal cancer. Our focus is steadfast on emerging as rapidly as possible as a clinical-stage company,” Biostage CEO Jim McGorry stated in the news release.
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About Biostage
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 (IND) application with the U.S. FDA in the third quarter of 2017. The IND will seek approval to initiate clinical trials for its esophageal implant product candidate in humans. For more information, visit www.biostage.com and connect with the Company on Twitter and LinkedIn.
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