Biostage pushes back human throat implant testing
PHOTO/LAURA FINALDI
Biostage CEO Jim McGorry (left) and Chief Medical Officer Saverio La Francesca hold one of the company's synthetic scaffolds that have worked to regrow esophaguses in pigs.
Under the advisement of the U.S. Food & Drug Administration, Biostage has decided to extend their animal testing of its Cellframe organ implants and push back its investigational new drug (IND) filing, the company announced Thursday.
Biostage management has opted to extend the duration of ongoing animal studies and now expects to file its IND application with the FDA by the end of the second quarter of 2017, according to a release from the company. This pushes back the company’s timeline for filing for its human testing of a bioengineered organ implants to regenerate parts of the throat for cancer patients.
The Holliston company, announced in May that it has already successfully regenerated a segment of esophagus in a study of the implants conducted with the Mayo Clinic using Yucatan pigs. It was planning on submitting its IND application with the goal of beginning human testing as early as the summer of 2017.
Although a disruption to its planned timeline, the company said that the meeting was positive overall and an affirmation of the clinical application of its technology. The company stated that it remains on track to file INDs for its Cellspan Pediatric Esophageal Implant and Cellspan Bronchial Implant as previously announced before the end of 2017.
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