Biostage (BSTG) Says FDA Requests It to Extend Pre-Clinical Large-Animal Safety Study for Cellspan Esophageal Implant

October 6, 2016 4:11 PM EDT
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Biostage, Inc. (Nasdaq: BSTG), ("Biostage" or the "Company"), a biotechnology company developing bioengineered organ implants to treat cancers and other life-threatening conditions of the esophagus, bronchus and trachea, announced today a regulatory update following its planned pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) for the advancement of its lead product candidate, Cellspan Esophageal Implant, into human clinical studies.

The feedback provided by the FDA to Biostage's proposed clinical protocol for its Cellspan Esophageal Implant provided clarity for a clinical path forward for its intended IND filing and the advancement into Phase 1 human clinical studies. During the meeting, the FDA requested that the Company extend its pre-clinical large-animal safety study for its Cellspan Esophageal Implant, which is currently ongoing and being conducted in compliance with the FDA Good Laboratory Practice (GLP) regulation. The basis for the FDA's recommended extension is to mirror the duration of the proposed Phase 1 human clinical study outlined in the Company's clinical protocol for its first-in-human clinical study. Biostage management has determined that it will extend the duration of the ongoing GLP animal studies and given this update, now expects to file its IND application with the FDA by the end of the second quarter of 2017.

Jim McGorry, CEO of Biostage, commented, "We had a substantive interaction with the FDA including an in-depth review of our novel combination technology and the current unmet medical need in the patient population addressed in our proposed plan to support an IND to initiate a Phase 1 human clinical study for our Cellspan Esophageal Implant. Our technology has the potential to fill a major treatment gap for patients with esophageal cancer. We will implement the FDA's recommendation to extend our ongoing GLP animal studies and believe the outcome of this meeting enables us to now have a significant amount of clarity regarding our path to advancing this novel product into a Phase 1 human clinical study."

"While the FDA's guidance to extend the preclinical study will extend the filing date of our IND, our meeting was very productive in that we were able to discuss the potential therapeutic value of our technology and our ongoing pre-clinical results. Importantly, the FDA, in principle, agreed to our clinical study approach. As a result of our meeting, we have a strong rationale to move forward with a de-risked plan that provides the safety requirements outlined by FDA. Additionally, we believe our pre-clinical approach potentially de-risks our clinical development strategy not only for our Cellspan Esophageal Implant product but more broadly for the advancement of our Cellframe Technology platform."

The Company further 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.

Mr. McGorry concluded, "We look forward to providing ongoing insight around the paradigm shift this novel product represents in the regenerative medicine space and how we have the potential to address these current unmet needs. We are on track to finalize our manuscript and publication in collaboration with Mayo Clinic on esophageal regeneration and host KOL events by year-end with additional data updates which we believe will further de-risk this program. Our number one priority is to emerge as rapidly as possible as a clinical stage company. We believe this will best position the Company to leverage our proprietary Cellframe technology platform enabling Biostage to offer a promising opportunity for people suffering from a variety of oncology indications, beginning with esophageal cancer as the foundational program for our pipeline."

As the Company previously reported, Saverio La Francesca, MD, Executive VP and Chief Medical Officer of Biostage will present at the Cell & Gene Meeting on the Mesa today at 3:15 p.m. PT. As part of his presentation, Dr. La Francesca will provide an overview of the Company's Cellframe technology which combines a proprietary biocompatible scaffold with a patient's own stem cells to create Cellspan organ implants.



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