InVivo Therapeutics Announces Update on the INSPIRE Study and FDA Approval of Expansion of the Study to 20 Evaluable Patients

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today provided an
update on the INSPIRE study of the Neuro-Spinal Scaffold™.
Patient Enrollments
InVivo announced that the 9th and 10th patients have been implanted with
the Neuro-Spinal Scaffold in the INSPIRE study. The 9th patient
was implanted at Vidant Medical Center, a Level 1 trauma center located
in Greenville, North Carolina. The implantation was performed by Vidant
Medical Group neurosurgeons Stuart Lee, M.D., the Principal Investigator
at the site, and Hilal Kanaan, M.D., approximately 40 hours after the
injury occurred. Dr. Lee said, “The implantation procedure went smoothly
and the patient is doing well. We are excited to be a part of the
INSPIRE study and look forward to following the patient’s progress.”
The 10th patient was implanted approximately 18 hours after the injury
by Domagoj Coric, M.D., of Carolina Neurosurgery and Spine Associates,
Chief of Neurosurgery at the Carolinas Medical Center and a member of
the INSPIRE Study Steering Committee. Dr. Coric and Dr. William
Bockenek, Chief Medical Officer at Carolinas Rehabilitation, are
Co-principal Investigators at this site. Regrettably, the 10th patient
died from a stroke several days after the implantation procedure. The
cause of death was deemed by Dr. Coric and the Chairman of the DSMB to
be unrelated to the Neuro-Spinal Scaffold or the implantation
procedure.
Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said, “We
express our condolences to the family of the patient who passed away.
Each loss of an individual with a spinal cord injury strengthens our
resolve to develop and bring to market new treatments that will improve
the lives of patients with these devastating injuries.”
Expansion of INSPIRE Study
As previously communicated, the INSPIRE study was approved originally to
enroll 12 patients pending review of six-month safety data from the
first five patients implanted with the Neuro-Spinal Scaffold. In
addition to the 10 implanted patients, two patients were screen
failures, which means that the patients consented to participate in the
study but failed to meet all of the inclusion and exclusion criteria of
the study. Although these two screen failure patients were not implanted
with the Neuro-Spinal Scaffold, they were technically enrolled
into the INSPIRE study. Therefore, the study had enrolled 12 patients by
the end of May (when the 10th patient was implanted by Dr. Coric) and
the enrollment of additional patients required action from the FDA.
After reviewing the six-month safety data, the FDA requested minor
modifications to the INSPIRE study protocol and informed consent
documents. These modifications are being incorporated, and the FDA has
approved the enrollment of additional patients to allow for 20 evaluable
patients (with six months of follow up data) in the INSPIRE study.
Because of the frequent interactions with the FDA over the last several
weeks regarding relatively minor modifications, InVivo chose to postpone
updates on the INSPIRE study until there was clarity regarding the path
forward. “We are pleased that the FDA has approved expansion of the
INSPIRE study that clears the way for enrolling all 20 evaluable
patients,” Mr. Perrin said. “While the pause in enrollment for the last
several weeks was unfortunate, this approval is an important step toward
our goal of approaching full enrollment of the INSPIRE study by the end
of the year.”
During the interactions regarding the expansion of the INSPIRE study,
the FDA also recommended that InVivo include a control arm in the study
as part of a Study Design Consideration. Mr. Perrin said, “As is typical
of the regulatory process, we have addressed a number of Study Design
Considerations regarding the INSPIRE study and its pilot precursor study
over the last two years. We have begun a constructive discussion with
the FDA regarding this Study Design Consideration, and we will provide
an update if substantial changes are made to the study protocol. We
continue to believe that our current study design is sufficient to
demonstrate safety and probable benefit in support of a Humanitarian
Device Exemption (HDE) application for marketing approval. Given the
encouraging results that we have observed to date, we look forward to
working with the FDA to complete the INSPIRE study as efficiently as
possible.”
About The INSPIRE Study
The 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, is designed to demonstrate
the safety and probable benefit of the Neuro-Spinal Scaffold™
for the treatment of complete T2-T12/L1 spinal cord injury in support of
a Humanitarian Device Exemption (HDE) application for approval. For more
information, refer to https://clinicaltrials.gov/ct2/show/study/NCT02138110.
About the Neuro-Spinal Scaffold™ Implant
Following acute spinal cord injury, surgical implantation of the
biodegradable Neuro-Spinal Scaffold within the decompressed and
debrided injury epicenter is intended to support appositional healing,
thereby reducing post-traumatic cavity formation, sparing white matter,
and allowing neural regeneration across the healed wound epicenter. The Neuro-Spinal
Scaffold, an investigational device, has received a Humanitarian Use
Device (HUD) designation and currently is being evaluated in the INSPIRE
pivotal probable benefit study for the treatment of patients with
complete (AIS A) traumatic acute spinal cord injury.
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 2011, the company earned the David S.
Apple Award from the American Spinal Injury Association for its
outstanding contribution to spinal cord injury medicine. In 2015, the
company’s investigational Neuro-Spinal Scaffold received the 2015
Becker’s Healthcare Spine Device Award. 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,” “designed to,”
“potentially,” and similar expressions, and include statements regarding
the safety and effectiveness of the Neuro-Spinal Scaffold, the pace of
enrollment and anticipated completion of enrollment of additional
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; whether the company will be required to
include a control arm in the INSPIRE study and any resulting impact on
the timing and completion of the INSPIRE study and approval of any HDE
application; the expected timing of completion of enrollment in the
INSPIRE study and submission of a HDE application; the timing of the
Institutional Review Board process; the company’s ability to obtain FDA
approval of a HDE application for its Neuro-Spinal Scaffold; the
company’s ability 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 the treatment of 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, 2015, 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.