InVivo Therapeutics Announces Contemporary Thoracic SCI Registry Study (the “CONTEMPO Registry Study”) Findings
March 19 2018 - 8:00AM
Business Wire
-Validates previously established Objective
Performance Criterion (OPC)-
InVivo Therapeutics Holdings Corp. (NVIV) today
announced top-line findings from its CONTEMPO Registry Study,
designed to provide comprehensive natural history benchmarks for
Neuro-Spinal Scaffold™ clinical study results. The CONTEMPO study
includes neurological recovery data from registries of spinal cord
injury (SCI) patients with similar baseline characteristics to
those in the INSPIRE study. Specifically, only patients injured
between 2006 and 2016 and meeting inclusion and exclusion criteria
similar to those in INSPIRE were included. Examples of such
criteria include age (16-70 years), T2-T12 neurological level of
injury (NLI), complete (AIS A), non-penetrating injury, acute
neurological exam within 7 days of injury, and follow-up
neurological exam at about 6 months post-injury. The results were
presented by James Guest, M.D., Ph.D., CONTEMPO Principal
Investigator and Professor of Neurological Surgery at the Miller
School of Medicine and the Miami Project to Cure Paralysis in
Miami, FL, at the 2018 Spine Summit, held in Orlando, FL.
A compilation of neurological recovery data from three
established SCI registries was used for the CONTEMPO Registry
Study, including the North American Clinical Trials Network
(NACTN), European Multicenter Study about Spinal Cord Injury
(EMSCI), and Spinal Cord Injury Model Systems. A total of 170
patients were included from the three registries: 12 individuals
from NACTN, 64 from EMSCI, and 94 from Model Systems. AIS
conversion rates at approximately six months post-injury varied
from 16.7% - 23.4% across the three registries.
In two of the registries, there was a skew of the patient
population to low (T10-T12) thoracic injuries, representing 46-47%
of the registry population. This compares to just four out of
sixteen patients (25%) in follow-up in the INSPIRE study with low
thoracic injuries. Patients with low thoracic injuries are known to
have the best prognoses, and the conversion rates were the highest
in the low thoracic group in all three registries and the INSPIRE
study. When all three registries were normalized to the INSPIRE
patient population distribution across T2-T5, T6-T9 and T10-T12
injury groups, the normalized conversion rate for CONTEMPO
registries ranged from 15.5%-20.6%.
“The CONTEMPO study represents a valuable compilation of
neurological recovery data from three established SCI registries.
This compilation, which is first of its kind, can help guide the
development of future clinical trial protocols and aid in the
interpretation of the safety and potential clinical benefit of new
therapies,” stated Dr. Guest.
“Given that published historical benchmarks for AIS conversion
rates were used to establish the INSPIRE OPC of 25%, we were
pleased to see that the CONTEMPO Registry Study results validated
and supported our OPC,” Richard Toselli, Chief Executive Officer,
said. “The CONTEMPO Study will be an important component of our
planned Humanitarian Device Exemption (HDE) regulatory submission,
and we were pleased to have Dr. Guest present topline findings of
the CONTEMPO Registry Study in Orlando.”
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
January 2018, the company announced updated clinical evidence,
including improvements in patients with acute spinal cord injury
(SCI), from its INSPIRE study of the Neuro-Spinal Scaffold™. 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 planned
HDE regulatory submission and the value of the CONTEMPO 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 identify financing alternatives and raise
the capital necessary to undertake the second pivotal trial, the
ability to successfully open additional clinical sites for
enrollment and to enroll additional patients if such trial is
initiated; 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, 2017, 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 Therapeutics Holdings Corp.Heather Hamel,
617-863-5530Investor
RelationsInvestor-relations@invivotherapeutics.com
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