InVivo Therapeutics Holdings Corp. (NVIV) today announced the
reopening of subject enrollment for the company’s ongoing pilot trial of
its investigational Neuro-Spinal Scaffold in patients with acute spinal
cord injury. To date, there have been no reported serious safety events
with the study’s first subject, and InVivo has been cleared by the Data
Safety Monitoring Board (DSMB) to move forward with the study. As
specified in the study protocol, the DSMB is a committee of independent
clinical research experts charged with examining the safety data
accumulated during the trial.
Mark Perrin, InVivo’s CEO, said, “It is gratifying to know that the
first subject is doing well and we are pleased to be moving forward with
our pilot study. Since enrolling the first subject, we have increased
the number of clinical sites from three to six, putting us in a much
better position to enroll the second subject. Although we cannot predict
when subjects will present, we anticipate enrolling our second subject
more quickly than our first.
As we have already announced, once the second subject is enrolled, the
FDA will require only 30 days of safety data for that subject, rather
than 90 days, before reopening enrollment. Barring any significant
safety issues, we anticipate reopening the study for concurrent
enrollment of subjects three through five about two months after the
second subject is enrolled,” Perrin said. “In parallel, we are taking
full advantage of a previous FDA approval and are making significant
progress to increase the number of participating clinical sites up to
20.”
This is the company’s first clinical study of its investigational
degradable polymer Neuro-Spinal Scaffold. The IDE pilot study has been
approved by the FDA and is intended to capture preliminary safety and
effectiveness data of the Neuro-Spinal Scaffold in five subjects with
acute thoracic spinal cord injury. InVivo then expects to conduct a
pivotal study to obtain FDA approval to commence commercialization under
a Humanitarian Device Exemption (HDE).
For more information, please visit the company’s ClinicalTrials.gov
registration site: http://clinicaltrials.gov/ct2/show/study/NCT02138110
About the Neuro-Spinal Scaffold
The biodegradable Neuro-Spinal Scaffold is surgically implanted at the
epicenter of the wound after an acute spinal cord injury and acts by
appositional healing to spare spinal cord tissue, decrease
post-traumatic cyst formation, and decrease spinal cord tissue pressure
in preclinical models of spinal cord contusion injury. The Neuro-Spinal
Scaffold, an investigational device, has received a Humanitarian Use
Device designation and is currently being studied in a pilot study for
the treatment of complete (AIS A) traumatic acute spinal cord injury.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a pioneering 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, ScD, Professor at Massachusetts Institute of
Technology, and Joseph P. Vacanti, MD, 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" and
similar expressions, and include statements regarding the pace of
enrollment of additional patients in the pilot trial; the company’s
ability to successfully open additional clinical sites for enrollment;
and the company’s ability to conduct a second pivotal 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 Annual Report on Form 10-K for the year
ended December 31, 2013, as amended, 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.
Copyright Business Wire 2015