InVivo Therapeutics Announces Complete 12-Month Data from the INSPIRE Study of the Investigational Neuro-Spinal Scaffold™ i...
August 28 2018 - 8:00AM
Business Wire
InVivo Therapeutics Holdings Corp. (Nasdaq: NVIV) today
announced the complete 12-month results from the company’s
single-arm 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).
As previously announced by InVivo, 7 of 16 (44%) patients who
reached the six-month primary endpoint visit in the INSPIRE study
had an ASIA Impairment Scale (AIS) conversion at 6 months, which is
the primary endpoint of the trial (defined as improvement in AIS
grade from baseline for all evaluable patients at the six-month
visit). The Objective Performance Criterion (OPC) (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.
Patients are scheduled to have full follow up visits at 12 and
24 months, and the visits include AIS conversion assessments. All
patients evaluated at the 12-month visit who had converted an AIS
grade at the 6 month visit remained converted at the 12 month
visit. One patient was lost to follow up after the 6-month visit
and was not assessed at a 12-month visit. Altogether, 19 patients
have been implanted with the Neuro-Spinal Scaffold in the INSPIRE
study. As previously disclosed, three patients died within two
weeks of implantation.
Richard Toselli, M.D., President and Chief Executive Officer of
InVivo, commented, “We will continue to follow this cohort of
patients as they progress through their 24-month follow up visit
and remain encouraged by the continued stability of the AIS
conversion rate past the six-month primary endpoint visit.”
InVivo has officially closed the INSPIRE study and has received
supplemental Investigational Device Exemption (IDE) approval from
the US Food and Drug Administration (FDA) for a second pivotal
clinical study of the company’s Neuro-Spinal Scaffold™ in
patients with acute SCI. The 20-patient (10 subjects in each study
arm), randomized, controlled trial, or INSPIRE 2.0, is designed to
enhance the existing clinical evidence for the Neuro-Spinal
Scaffold™ from the company’s single-arm INSPIRE study.
InVivo is currently focused on the initiation of the INSPIRE 2.0
study.
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
January 2018, the company announced updated clinical evidence,
including improvements in patients with acute spinal cord injury
(SCI), from its INSPIRE study of the Neuro-Spinal Scaffold™. 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” and similar
expressions, and include statements regarding future clinical
investigation of the Company’s Neuro-Spinal Scaffold. 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: successfully
decreasing costs and spending and successfully opening additional
clinical sites for enrollment and enrolling additional patients if
such trial is initiated; the timing of the Institutional Review
Board process; the company’s ability to obtain FDA approval to
commercialize its products; the company’s ability to develop,
market and sell products based on its technology; the expected
benefits and efficacy of the company’s products and technology in
connection with spinal cord injuries; the availability of
substantial additional funding for the company to continue its
operations and to conduct research and development, clinical
studies and future product commercialization; and other risks
associated with the company’s business, research, product
development, regulatory approval, marketing and distribution plans
and strategies identified and described in more detail in the
company’s Annual Report on Form 10-K for the year ended December
31, 2017 and its other filings with the SEC, including the
company’s quarterly reports on Form 10-Q and current reports on
Form 8-K. The company does not undertake to update these
forward-looking statements.
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InVivo Therapeutics Holdings Corp.Heather Hamel,
617-863-5530Investor
RelationsInvestor-relations@invivotherapeutics.com
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