CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced that
the first two patients have been enrolled into The INSPIRE 2.0
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).
“Having the first two patients enrolled into the INSPIRE 2.0 Study is a
critical milestone for the company and for the spinal cord injury
patient population, as there continues to be inadequate treatment
options for these patients. With eight clinical sites now open for
enrollment, we remain optimistic about continuing to execute on the
INSPIRE 2.0 study and will provide updates when appropriate,” commented
Richard Toselli, M.D., President and Chief Executive Officer of InVivo.
The INSPIRE 2.0 Study is a two-arm 20-patient (10 subjects in each study
arm), randomized, controlled trial designed to provide clinical data
that will supplement the existing clinical results from the company’s
previous single-arm study (INSPIRE 1.0). The definition of study success
for the INSPIRE 2.0 Study is that the difference in the proportion of
subjects who demonstrate an improvement of at least one grade on ASIA
Impairment Scale (AIS) assessment at the six-month primary endpoint
follow-up visit between the Scaffold Arm and the Comparator Arm must be
equal to or greater than 20%.
“We appreciate the investigators’ continued focus and willingness to
support not only this trial, but also this underserved patient
population. Ultimately, we hope to address a large unmet medical need
for spinal cord injury patients,” concluded Dr. Toselli.
INSPIRE 1.0 Study Results
As previously announced by InVivo, 7 of 16 (44 percent) patients who
reached the six-month primary endpoint visit in the INSPIRE 1.0 Study
had an AIS conversion at 6 months, which is the primary endpoint of the
INSPIRE 1.0 Study (defined as improvement in AIS grade from baseline for
all evaluable patients at the six-month visit). Altogether, 19 patients
were implanted with the Neuro-Spinal Scaffold in the INSPIRE
1.0 Study, which is officially closed. Three patients died within two
weeks of implantation, each death deemed unrelated to the Neuro-Spinal
Scaffold or implantation procedure by the respective site’s
Principal Investigators. The Objective Performance Criterion (study
success definition) for the INSPIRE 1.0 Study was a 25 percent AIS
conversion rate based on the published conversion rates for thoracic
spinal cord injury reported in the literature.
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. 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 expectations related to continued
updates from the INSPIRE 2.0 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 Quarterly Report on Form 10-Q for the quarter
ended March 31, 2019, and its other filings with the SEC, including the
Company’s Form 10-K, 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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