InVivo Therapeutics Provides Enrollment Update for INSPIRE 2.0 Study for the Treatment of Acute Spinal Cord Injury
October 22 2019 - 08:00AM
Business Wire
- First Five Patients Enrolled into Study,
Reaching 25% Completion of Targeted Enrollment –
InVivo Therapeutics Holdings Corp. (NVIV) today announced
that a total of five 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), bringing the study to 25% completion of targeted
enrollment. The first patient was enrolled into the INSPIRE 2.0
Study in May of 2019, and 14 sites are currently open for
enrollment into the study.
Richard Toselli, M.D., President and Chief Executive Officer of
InVivo, said, “We made a dedicated effort to efficiently activate
strategic clinical sites during the first half of the year and are
pleased with the resulting pace of enrollment to date, with our
team maintaining focus on enrollment efforts and engagement at the
site level. In addition, we appreciate the investigators’ support
of this trial, which we believe has the potential to address a long
unmet medical need for spinal cord injury patients.”
About the INSPIRE 2.0 Study
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
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%.
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 and outcomes 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 June
30, 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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