InVivo Therapeutics Announces Presentation of Twelve-Month Results from the INSPIRE Study of the Investigational Neuro-Spinal...
April 17 2019 - 8:00AM
Business Wire
- E-poster Presented at the 2019 American
Association of Neurological Surgeons (AANS) Annual Scientific
Meeting -
InVivo Therapeutics Holdings Corp. (Nasdaq: NVIV)
(“InVivo” or the “Company”) today announced the presentation of the
twelve-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). The findings were
presented at the 2019 AANS Meeting in San Diego, CA through an
e-poster titled, “Twelve Month Results from the INSPIRE Study of
the Investigational Neuro-Spinal Scaffold™ in Acute Thoracic
Complete Spinal Cord Injury”, co-authored by Kee Kim, M.D.,
Department of Neurosurgery, UC-Davis, Sacramento, CA, K. Stuart
Lee, M.D., Division of Neurosurgery, Vidant Health, Greenville, NC,
Lee, Domagoj Coric, M.D., Carolina Neurosurgery and Spine,
Charlotte, NC, Nicholas Theodore M.D., Department of Neurosurgery,
Johns Hopkins Hospital, Baltimore, MD, and Richard Toselli, M.D.,
President and Chief Executive Officer of InVivo.
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). Of the seven patients who reached the six-month primary
endpoint visit, six patients were later evaluated at the 12-month
exam and one patient was lost to follow-up before the 12-month
exam. All six patients who were examined at the 12-month exam and
had previously converted at the six-month exam remained converted
at the 12-month exam. Further, two of those six patients were
assessed to have AIS B spinal cord injury (SCI) at the six-month
primary endpoint but were later assessed to have improved to
AIS C SCI at the 12-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 SCI reported in the literature.
Dr. Toselli commented, “In addition to focusing on enrollment in
the INSPIRE 2.0 Study, we look forward to continuing to follow this
cohort of INSPIRE patients through their 24-month follow up visit,
and we remain encouraged by the continued stability of the AIS
conversion rates.”
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 the expected timing
for enrollment in the Inspire 2.0 Study and expectations regarding
continued follow up with patients in the INSPIRE Study. 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
ability to successfully open additional clinical sites for
enrollment and to enroll additional patients; 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, 2018, and its other filings with the SEC, including the
Company’s Form 10-Qs and current reports on Form 8-K. The Company
does not undertake to update these forward-looking statements.
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