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.
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 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 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 performance,
regenerative properties and reproducibility of our technology,
including the Cellspan Esophageal Implant, or any success of this
approved single-use expanded access use, which expectations may not
be achieved; 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 and our
ability to complete the private placement on a timely basis or at
all; 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:
Tom McNaughton
Chief Financial Officer
774-233-7321
tmcnaughton@biostage.com
Media Contacts:
Maggie
Beller
Russo Partners LLC
646-942-5631
maggie.beller@russopartnersllc.com
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SOURCE Biostage Inc.