InVivo Therapeutics Announces Enrollment of Fifth Patient in Pilot Spinal Cord Injury Study
September 08 2015 - 8:00AM
Business Wire
- 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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InVivo TherapeuticsBrian Luque, 617-863-5535Investor
Relationsbluque@invivotherapeutics.com
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