InVivo Therapeutics Announces Enrollment of First Two Patients into the INSPIRE 2.0 Study for the Treatment of Acute Spinal C...
May 29 2019 - 8:00AM
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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