InVivo Therapeutics Announces Latest Results from INSPIRE and Provides Update on Proposed Clinical Path Forward
04 January 2018 - 12:00AM
Business Wire
InVivo Therapeutics Holdings Corp. (Nasdaq:
NVIV) today announced the latest results from The
INSPIRE Study (InVivo Study of Probable Benefit of
the Neuro-Spinal Scaffold™ for Safety and Neurologic
Recovery in Subjects with Complete Thoracic AIS A Spinal
Cord Injury). The primary endpoint of the study is defined as
improvement in ASIA Impairment Scale (AIS) grade from baseline for
all evaluable patients at the six-month visit. Nineteen patients
have been implanted with the Neuro-Spinal Scaffold. Three patients
died within two weeks of implantation. The 16 evaluable patients
have now all reached the six-month primary endpoint visit. Seven of
the 16 (43.8%) evaluable patients had an AIS grade improvement from
baseline at six months. The Objective Performance Criterion (study
success definition) for the study was a 25% AIS conversion rate
based on the published conversion rates for thoracic spinal cord
injury (SCI) reported in the literature.1,2
The most recent patient to reach the primary endpoint visit was
assessed to be AIS C (motor incomplete) at six months, meaning that
some motor function was detected at the sacral level. Of the seven
INSPIRE patients who had AIS improvements at six months, five
patients improved from complete AIS A SCI to sensory incomplete AIS
B SCI, and two patients improved from complete AIS A SCI to motor
incomplete AIS C SCI. Two of the five patients who were assessed to
be AIS B at six months later improved to AIS C at 12 or 24
months.
In July 2017, enrollment of patients in the INSPIRE study was
placed on hold following the third patient death. Although InVivo
and the respective site principal investigators believe these
deaths were not related to the Neuro-Spinal Scaffold
investigational device, the company is in discussions with the FDA
to ensure that these cases have been comprehensively evaluated and
to ensure that all appropriate risk mitigation measures have been
implemented. As part of those ongoing discussions, InVivo has
proposed a randomized controlled trial to supplement the existing
clinical evidence for the Neuro-Spinal Scaffold. InVivo does not
anticipate reopening enrollment in INSPIRE and expects to provide
additional clarity on its clinical path forward in the second
quarter of 2018.
“I am pleased to report the latest AIS conversion results from
INSPIRE,” said Richard Toselli, Acting Chief Executive Officer.
“INSPIRE demonstrated the surgical feasibility of Neuro-Spinal
Scaffold implantation and produced encouraging data on AIS
conversions at six months compared to the Objective Performance
Criterion and natural history reported in the literature. We remain
in discussions with the FDA regarding the clinical path forward in
support of a Humanitarian Device Exemption filing. We are working
diligently to provide clarity as expeditiously as possible as we
evaluate various strategic and financing options. I look forward to
providing more details on our proposed randomized controlled study
in the second quarter of 2018.”
1 Zariffa et al., Spinal Cord (2011)2 Lee et al., J. Spinal Cord
Med (2014)
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a research and
clinical-stage biomaterials and biotechnology company with a focus
on treatment of spinal cord injuries. The company was founded in
2005 with proprietary technology co-invented by Robert Langer,
Sc.D., Professor at Massachusetts Institute of Technology, and
Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital
and who now is affiliated with Massachusetts General Hospital. In
2011, the company earned the David S. Apple Award from the American
Spinal Injury Association for its outstanding contribution to
spinal cord injury medicine. In 2015, the company’s investigational
Neuro-Spinal Scaffold™ received the 2015 Becker’s Healthcare Spine
Device Award. The publicly traded company is headquartered in
Cambridge, MA. For more details, visit
www.invivotherapeutics.com.
Safe Harbor Statement
Any statements contained in this press release that do not
describe historical facts may constitute forward-looking statements
within the meaning of the federal securities laws. These statements
can be identified by words such as "believe," "anticipate,"
"intend," "estimate," "will," "may," "should," "expect," “designed
to,” “potentially,” and similar expressions, and include statements
regarding the status of the company’s clinical program. Any
forward-looking statements contained herein are based on current
expectations, and are subject to a number of risks and
uncertainties. Factors that could cause actual future results to
differ materially from current expectations include, but are not
limited to, risks and uncertainties relating to the company’s
discussions and engagement with the FDA; the company’s ability to
initiate, conduct and complete clinical trials; the expected
benefits and potential efficacy of the company’s products and
technology in connection with the treatment of spinal cord
injuries; the availability of substantial additional funding for
the company to continue its operations and to conduct research and
development, clinical trials and future product commercialization;
and other risks associated with the company’s business, research,
product development, attainment of regulatory approval, marketing
and distribution plans and strategies identified and described in
more detail in the company’s Quarterly Report of the three months
ended September 30, 2017, and its other filings with the SEC,
including the company’s most recent Form 10-K, its Form 10-Qs and
its current reports on Form 8-K. The company does not undertake to
update these forward-looking statements.
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InVivo Therapeutics Holdings CorpHeather Hamel,
617-863-5530Investor
RelationsInvestor-relations@invivotherapeutics.com
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