InVivo Therapeutics Holdings Corp. (NVIV) announced it has
received conditional approval of a study protocol amendment from the
U.S. Food and Drug Administration (FDA) that will convert its ongoing
pilot study into a pivotal probable benefit study. The approval is
conditional solely upon a minor change to the informed consent form that
has already been submitted to the FDA. Full approval of the amendment is
expected in the next 30 days.
With this transition, the study will be known formally as “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.” The INSPIRE Study is
designed to enroll 20 implanted patients, inclusive of the five patients
already enrolled. The primary endpoint is defined as the proportion of
patients achieving an improvement of at least one ASIA Impairment Scale
(AIS) grade at 6 months post-implantation.
The INSPIRE study is conditionally approved to enroll up to 12 patients,
but InVivo expects that the FDA will approve the full 20 patients
following the review of 6-month safety data for the first five patients.
The company plans to submit these data in the second quarter of 2016.
An objective performance criterion (OPC) for the study to support
probable benefit using historical benchmarks is under discussion with
the FDA. In large European and US databases, the published rates of
spontaneous improvement of at least one AIS grade in complete (AIS A),
thoracic SCI patients at 6 months are less than 16%. An additional study
protocol amendment may be required to establish the OPC.
The inclusion criteria have also been broadened to include patients with
T2 injuries (new range T2-T12/L1) and ages 16-17 (new range 16-70). The
FDA has also agreed to increase the total number of allowable U.S. sites
to 40. In addition to the U.S. sites, the company plans to initiate the
study in Canada and the United Kingdom with the intent to include
patients enrolled at ex-U.S. sites as part of the 20 patient study.
“This conditional approval marks one of the most significant corporate
milestones the company has achieved to date. Being able to convert our
pilot study into a small pivotal probable benefit study provides us with
a very efficient path to commercialization,” said Mark Perrin, Chief
Executive Officer and Chairman. “We anticipate completing enrollment in
the pivotal probable benefit study and submitting an application for
Humanitarian Device Exemption (HDE) approval in 2017.”
The company will continue to announce the enrollment of each patient and
any conversions of AIS classification as well as any other dramatically
positive or negative events. The company will also seek to communicate
interim results at various scientific and medical meetings. The company
does not consider a patient’s unchanged AIS classification or a
medically insignificant adverse event to be material.
The company will discuss the details of the pivotal probable benefit
study during tonight’s KOL Event and Company Update webcast, which
begins at 5:15PM ET and will be broadly accessible through lifesci.rampard.com/20151203.
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) 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 FDA’s conditional approval of the company’s
pivotal probable benefit study, the expected timing of the FDA’s full
approval, and the expected timing of completion of enrollment in the
study and subsequent application for HDE approval and commercialization.
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 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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