HOLLISTON, Mass., Oct. 6, 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, 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.
A video webcast of the Company's presentation from the Cell
& Gene Meeting on the Mesa is available at:
www.meetingonthemesa.com/webcast/track2/ and will also be published
on the Alliance for Regenerative Medicine's website shortly after
the event.
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 multistep
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 Implant
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, improve quality of life and enable
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 pre-clinical studies. Pre-clinical, large-animal
safety studies, conducted in compliance with the FDA Good
Laboratory Practice (GLP) regulations, for the Company's Cellspan
Esophageal Implant product candidate have begun, in support of
Biostage's goal of filing an Investigational New Drug (IND)
application with the U.S. FDA by the end of the second 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 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.
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
|
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SOURCE Biostage, Inc.