HOLLISTON, Mass., June 19, 2017 /PRNewswire/ -- 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 that it presented positive preclinical
data of its proprietary Cellspan™ Esophageal Implant at the
International Society for Stem Cell Research (ISSCR) 2017 Annual
Meeting held June 14-17, 2017 in
Boston, MA.
KaLia Burnette, Biostage's Senior
Research Associate, presented the poster (No. F-3043) titled,
"Esophageal Regeneration with a Cell-Seeded Tissue Engineered
Graft," in a poster presentation on Friday,
June 16, 2017.
"Current reconstruction approaches are limited to utilization of
an autologous conduit such as the stomach, small bowel, or colon,
and we believe that our Cellspan Esophageal Implant, which provides
the potential for esophageal replacement or regeneration for
circumferential, full thickness defects, would have significant
clinical application and provide a groundbreaking solution for this
unmet medical need," Saverio La Francesca, MD, Biostage's President
and Chief Medical Officer, stated.
A synthetic graft was seeded with autologous adipose-derived
mesenchymal stem cells (aMSCs). Confirmation of aMSC-based seeding
was performed and anesthetized pigs have undergone full thickness
circumferential resection of a length of the esophagus in the
ongoing preclinical study. Implantation of the Cellspan Esophageal
Implant and esophageal stent deployment was performed, and the
scaffolds were then removed endoscopically after 3 weeks following
the regeneration of vascularized tissue, having reconstituted the
continuity and structural integrity of the esophagus. Animals
surviving up to 10 months showed durable tolerance to oral intake
and weight gain. Progressive esophageal regeneration, initiated by
the Cellspan Esophageal Implant, was observed over the course of
this study,as results from these animals showed gradual structural
regeneration of endogenous esophageal tissue layers, including
squamous esophageal mucosa, submucosa, and blood vessel formation.
Results from the study have implications for the esophagus as a
regenerative organ, and for novel applications in human esophageal
resection.
Charles S. Cox, Jr., MD, Professor of Pediatric Surgery,
McGovern Medical School at UTHealth, George and Cynthia Mitchell
Distinguished Chair of Neuroscience, stated, "Biostage's tissue
engineered esophageal replacement offers new therapeutic options in
difficult reconstructive circumstances, reducing the need for
tissue transfers and more extensive operations."
Jim McGorry, CEO of Biostage, commented, "In our ongoing
large-animal model preclinical studies, we have been able to
continually and consistently demonstrate that esophageal
regeneration is feasible and reproducible with our Cellspan
Esophageal Implant utilizing our proprietary Cellframe™ technology.
This gives us additional confidence as we look forward to
transitioning this technology into its first-in-human clinical
study by the end of 2017."
Cellspan Esophageal Implants utilize the Company's proprietary
Cellframe™ technology and may offer improved outcomes for patients
by potentially simplifying surgical techniques to reduce
postoperative complications and improve quality of life, by
prompting regeneration 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
improve post-surgical morbidity.
In November 2016, the Company's
Cellspan Esophageal Implant was granted Orphan Drug Designation by
the U.S. Food and Drug Administration ("FDA") to restore the
structure and function of the esophagus subsequent to esophageal
damage due to cancer, injury or congenital abnormalities.
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 U.S. Food and Drug
Administration ("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 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 and connect
with the Company on Twitter and LinkedIn.
Forward-Looking Statements:
Some of the statements in this press release are
"forward-looking" and are made pursuant to the safe harbor
provision of the Private Securities Litigation Reform Act of 1995.
These "forward-looking" statements in this press release include,
but are not limited to, statements relating to the development
expectations and regulatory approval of any of our products,
including those utilizing our Cellframe technology, by the U.S.
Food and Drug Administration, the European Medicines Agency or
otherwise, which expectations or approvals may not be achieved or
obtained on a timely basis or at all; or success with respect to
any collaborations, clinical trials and other development and
commercialization efforts of our products, including those
utilizing our Cellframe technology, which such success may not be
achieved or obtained on a timely basis or at all. These statements
involve risks and uncertainties that may cause results to differ
materially from the statements set forth in this press release,
including, among other things, our ability to obtain and maintain
regulatory approval for our products; plus other factors described
under the heading "Item 1A. Risk Factors" in our Annual Report on
Form 10-K for the fiscal year ended December
31, 2016 or described in our other public filings. Our
results may also be affected by factors of which we are not
currently aware. The forward-looking statements in this press
release speak only as of the date of this press release. Biostage
expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to such statements to reflect any
change in its expectations with regard thereto or any changes in
the events, conditions or circumstances on which any such statement
is based.
Investor Relations
Contacts:
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Tom
McNaughton
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Jenene
Thomas
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Chief Financial
Officer
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Jenene Thomas
Communications LLC
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774-233-7321
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(908)
938-1475
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tmcnaughton@biostage.com
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jtc@jenenethomascommunications.com
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Media
Contacts:
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David Schull or
Maggie Beller
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Russo Partners
LLC
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212-845-4271 or
646-942-5631
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Email:
Maggie.beller@russopartnersllc.com
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SOURCE Biostage Inc.