- Communicates Intent to Incorporate Pilot Study into Pivotal
Probable Benefit Study -
InVivo Therapeutics Holdings Corp. (NVIV) today announced that
the fifth patient has been enrolled in the company’s ongoing pilot study
of its investigational Neuro-Spinal Scaffold™ implant in patients
with acute thoracic spinal cord injury at the Keck Hospital of
University of Southern California (USC) in Los Angeles.
Patrick Hsieh, M.D., Principal Investigator at this site, performed the
fifth-ever Neuro-Spinal Scaffold implantation approximately 69
hours after the injury occurred.
“Enrolling the fifth patient in our first clinical study is a momentous
milestone for the company, and we are pleased this accomplishment came
ahead of previous guidance,” said Mark Perrin, InVivo’s CEO and
Chairman. “We are in productive discussions with the FDA regarding the
transition to the pivotal probable benefit study, and our plan is to
incorporate the pilot study into the pivotal probable benefit study. We
expect to use this single study as the basis for a Humanitarian Device
Exemption (HDE) application, which would allow us to dramatically reduce
the time to approval and commercialization.”
Mr. Perrin continued, “While we are discussing plans with the FDA for
the pivotal probable benefit study and the incorporation of the pilot
study, we intend to request expanding the number of patients in the
current pilot study beyond five to further compress clinical timelines.
We anticipate that we will receive formal approval of this expansion
within the next two months. During this interim period, additional
eligible patients at participating clinical sites may receive the Neuro-Spinal
Scaffold under the Emergency Use Expanded Access Mechanism on a
case-by-case basis, and the safety and outcomes data from these patients
will be included in the HDE application. We have fostered a
collaborative relationship with the FDA, and we are optimistic that we
will finalize the pivotal probable benefit study design in the coming
months.”
For more information, please visit the company’s ClinicalTrials.gov
registration site: http://clinicaltrials.gov/ct2/show/study/NCT02138110
About the Neuro-Spinal Scaffold™
Following an acute spinal cord injury, the biodegradable Neuro-Spinal
Scaffold is surgically implanted at the epicenter of the wound and
is designed to act as a physical substrate for nerve sprouting.
Appositional healing to spare spinal cord tissue, decreased
post-traumatic cyst formation, and decreased spinal cord tissue pressure
have been demonstrated in preclinical models of spinal cord contusion
injury. The Neuro-Spinal Scaffold, an investigational device, has
received a Humanitarian Use Device (HUD) designation and is currently
being studied in an Investigational Device Exemption (IDE) pilot 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. 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 FDA’s approval of a new pivotal study and/or an
expansion of the company’s pilot study and the timing of such approvals
and the nature of the company’s negotiations with the FDA and the
timeline for commercialization of the Neuro-Spinal Scaffold. 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 volatility of the trading price of the
company’s common stock; 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 modify its pilot trial
protocol or to conduct a future study; 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, 2014, 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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