It’s all happening at InVivo Therapeutics. In a flurry of news releases the company has appointed a new CEO, gained conditional approval to commence its US trial and gone ahead and satisfied the conditions with a series of responses to the FDA’s outstanding issues. The study will commence with first patients in early March.
Just before Christmas InVivo Therapeutics Holdings Corp. gained conditional FDA approval to commence a clinical study to test the safety of its investigational scaffold device for spinal cord repair. Now it says it has sent to the US FDA the revised protocol and related study documents including all changes that were conditions of approval by the FDA. It will now send the revised protocol and related study documents to six sites in the United States so that they can 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 the company admits 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.
InVivo 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.”
Source: InVivo Therapeutics, Holdings, Inc.