InVivo Therapeutics Holdings Corp. (NVIV) today announced a
three-month update for the first subject in the company’s ongoing pilot
trial of its investigational Neuro-Spinal Scaffold in subjects with
acute spinal cord injury. The Neuro-Spinal Scaffold was implanted in the
subject on October 14, 2014 at the Barrow Neurological Institute at St.
Joseph’s Hospital and Medical Center in Phoenix, AZ by Dr. Nicholas
Theodore, Chief of Spinal Surgery.
In the time between implantation and the 3-month post-injury assessment,
there were no reported serious adverse events associated with the
Neuro-Spinal Scaffold and the subject had progressed from a complete AIS
A injury to an incomplete AIS C injury with motor, sensory, bowel, and
bladder function improvements. Motor improvement from the pre-surgery
assessment to the 3-month visit involved the return of active movement
of the hip flexors against gravity (allowing for leg to chest motions)
and palpable contractions of the knee extensors. Sensory improvement
from the pre-surgery assessment to the 3-month visit involved the
bilateral return of sensation to two dermatomes extending down the top
of the subject’s legs and the S4-S5 dermatome. In addition, the
International Standards for Neurological Classification of Spinal Cord
Injury (ISNCSCI) exam, the Spinal Cord Independence Measure (SCIM III)
exam, and additional assessments of bowel and bladder function
demonstrated that between hospital discharge and the 3-month visit, the
subject has regained bowel function and improved bladder function.
Dr. Theodore said, “I am very pleased with the first subject’s progress
since the scaffold was implanted. In my experience, this degree of
sensory and motor improvement is unexpected. However, this is only one
patient and we do not want to over-interpret the data.”
Mark Perrin, InVivo’s CEO, said, “We are impressed with the first
subject’s progress to date since comparable spontaneous recovery occurs
infrequently in patients with similar injuries. We look forward to
continuing to evaluate the Neuro-Spinal Scaffold in this first subject
and the remaining subjects planned for this study.”
The data from the first subject were obtained and calculated in
accordance with the ISNCSCI, the standard examination used to determine
motor and sensory impairment and severity of a spinal cord injury. A
copy of the ISNCSCI exam worksheet can be found on the American Spinal
Injury Association (ASIA) website at http://www.asia-spinalinjury.org/elearning/ISNCSCI.php.
This is the company’s first clinical study of its investigational
degradable polymer Neuro-Spinal Scaffold. The Investigational Device
Exemption (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. As
previously announced, the company has reopened the trial for enrollment
of its second subject. Following the pilot trial, InVivo 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 company’s
ability to enroll additional patients in the pilot trial; the degree of
improvement in the first subject after implantation of the Scaffold
compared to other patients; 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