HOLLISTON, Mass., June 29, 2016 /PRNewswire/ -- Biostage, Inc.
(Nasdaq: BSTG), a biotechnology company developing bioengineered
organ implants to treat cancers and other life-threatening
conditions of the esophagus, bronchus and trachea, today announced
it has submitted an application with the U.S. Food and Drug
Administration seeking orphan drug designation for its Cellspan
Esophageal Implants.
The Orphan Drug Act of 1983 provides a range of incentives to
encourage research and development investment in treatments for
rare medical conditions. These incentives include seven-year market
exclusivity commencing on product approval; tax credits; assistance
in regulatory proceedings – fast-track registrations; and full
exemption from the FDA's drug registration fees.
To receive orphan drug designation, a company must demonstrate
that the condition addressed by the drug or biologic affects less
than 200,000 persons in the U.S. The company must also provide the
FDA with sufficient information to establish a medically plausible
basis for expecting the product will be an effective treatment.
Biostage CEO Jim McGorry
commented, "This submission is the first step in our effort to
secure orphan status for our Cellspan esophageal implant, which we
believe has the potential to be a valuable option in the treatment
of esophageal cancer. The Biostage team is executing on the
key initiatives required to advance into human clinical trials for
our esophageal implant product candidate, and we remain on track
with our plan to conclude its pre-clinical development, to publish
our large-animal study results and to execute our related Good
Laboratory Practices (GLP) studies during Q3 and into Q4."
Mr. McGorry continued, "Our plan and goal is to file an
Investigational New Drug application (IND) with the FDA by the end
of the current year. Assuming approval on a normal time-frame, we
believe that by this time next year our Cellspan esophageal implant
should be in a human clinical pilot study."
About Biostage, Inc.: www.biostage.com
Biostage is a biotechnology company developing bioengineered organ
implants utilizing 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 and 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 a
collaborative preclinical study. This testing is intended to expand
the base of preclinical data in support of Biostage's goal of
filing an Investigational New Drug (IND) application with the U.S.
FDA in late 2016. The IND will seek approval to initiate clinical
trials for its esophageal implants in humans.
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 FDA, EMA, MHRA 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.
Twitter: @BiostageIR
StockTwits: BiostageIR
Media/Investor
Relations Contact:
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Tom
McNaughton
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David Collins, Bill
Jones
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Chief Financial
Officer
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Catalyst Global
LLC
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774-233-7321
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212-924-9800 w; 917
734-0339 m
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bstg@catalyst-ir.com
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SOURCE Biostage, Inc.