HOLLISTON, Mass., Dec. 1, 2016 /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, today announced that its 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.
The FDA Orphan Drug Designation program provides a special
status to drugs and biologics intended to treat, diagnose or
prevent diseases and disorders that affect fewer than 200,000
people in the U.S. 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.
"The Orphan Drug Designation for our Cellspan Esophageal Implant
is an important achievement in our regulatory strategy as we
advance this novel product candidate that we believe, has the
opportunity to create a significant treatment paradigm shift in
regenerative medicine," said Jim McGorry, CEO of Biostage. "Based
on preclinical, large-animal studies conducted to date, we believe
our Cellspan esophageal implants may have the potential to offer
improved outcomes for patients by reducing post-operative
complications and providing an improved quality of life, by
prompting regeneration of the patient's own esophagus."
The Company recently provided a regulatory update of its
Cellspan esophageal implant following its substantive pre-IND
meeting with the FDA. The feedback provided by the FDA to
Biostage's proposed clinical protocol for its esophageal implant
provided clarity for a clinical path forward for its intended
Investigational New Drug (IND) application and the advancement into
Phase 1 human clinical studies. The Company expects to file its IND
in the third quarter of 2017 and commence 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," concluded Mr. McGorry.
About Cellframe™ Technology
The Company's proprietary
Cellframe technology is designed to harness the full potential of
the in vivo microenvironment to achieve tissue regeneration
and restore organ function. It employs a multi-step process in
which the patient's own stem cells are taken from a simple
adipose/fat tissue biopsy, expanded and banked, and then seeded
onto a proprietary scaffold that mimics the natural dimensions of
the organ being regenerated. After several days in a rotating
bioreactor, the biocompatible scaffold containing the stem cells is
ready to be implanted. Preclinical studies suggest that the organ
implant signals the stem cell niche in the surrounding native
tissue to guide the regeneration of a biological structure. This
technology is based on the concept of in situ tissue
regeneration using the body's own biologic resources and reparative
capability in combination with tissue-specific biomaterials
implanted at the sites of disease or injury.
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 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.
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, 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, 2015 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
|
Jenene
Thomas
|
Chief Financial
Officer
|
Jenene Thomas
Communications LLC
|
774-233-7321
|
(908)
938-1475
|
tmcnaughton@biostage.com
|
jtc@jenenethomascommunications.com
|
|
|
Media
Contacts:
|
David Schull or
Maggie Beller
|
|
Russo Partners
LLC
|
|
212-845-4271 or
646-942-5631
|
|
Email:
Maggie.beller@russopartnersllc.com
|
|
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SOURCE Biostage, Inc.