InVivo Therapeutics Holdings Corp. (NVIV) today announced that it
has sent to the United States Food and Drug Administration the revised
protocol and related study documents for a clinical study to test the
safety of its investigational scaffold device for spinal cord repair.
The revised protocol includes all changes that were conditions of
approval by the FDA. On Monday, it will send the revised protocol and
related study documents to six sites in the United States so that they
can now begin their Institutional Review Board submissions and finalize
clinical study contracts with InVivo.
With the in-house manufacturing process still on track to provide
scaffolds in mid-February, InVivo expects that its first clinical study
site will be ready to enroll subjects in the first two weeks of March,
although it is difficult to project when the first subject will both
present at the hospital and consent to participate in the study. The
company expects that the wait for each enrolled subject will decrease as
the number of sites expands to six.
The company also announced that it has completed a strategic review of
its Hydrogel program and will focus its efforts on accelerating one
program rather than diluting its limited resources with multiple
projects. The company expects that it will decide in the second quarter
whether that program will be funded by a partnership currently under
discussion with a larger company which owns a proprietary protein or
whether it will be a self-generated program. In the meantime, InVivo
scientists are producing more safety data on their Hydrogel platform so
that products being developed will be more ready for licensing and
clinical trials.
Interim Chief Executive Officer Michael Astrue said, “Today’s
announcements mark the end of a difficult but successful transition
period for InVivo. Our incoming Chief Executive Officer, Mark Perrin,
will inherit dedicated employees and a realistic strategic plan that can
generate enormous value for shareholders. I am confident in Mark’s
ability to take this company to the next level.”
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a pioneering biomaterials company
with unique technologies for drug development and 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, M.D., who
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. Any forward-looking statements
contained herein are based on current expectations, but are subject to a
number of risks and uncertainties, and include statements regarding the
Company’s expectations with respect to the commencement of human
clinical trials for the scaffold product, the timing of Institutional
Review Board submissions and contract finalization, and expectations
with respect to the hydrogel program, including, but not limited to, a
possible partnership and the ability of such partnership to fund such
program. The 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 participation of appropriate
clinical sites; the Institutional Review Board review and approval
process; the Company’s ability to enter into contracts with the sites
necessary to begin accruing patients; the timing of patient
availability; the timing of patient consents; the Company’s ability to
enter into partnerships; 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 our filings with
the SEC, including our Form 10-K and 10-Qs and our current reports on
Form 8-K. We do not undertake to update these forward-looking statements
made by us.
Copyright Business Wire 2014