Whenever we write about InVivo Therapeutics, there seems to be trouble at t’mill. Not today though, as the company has announced that the US FDA has approved various changes to the protocol for the company’s ongoing IDE pilot trial for acute spinal cord injury (SCI), which look like the agency might be liking what it sees.
Background
InVivo Therapeutics Holdings Corp. is a pioneering biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. Its biodegradable Neuro-Spinal Scaffold is intended for surgical implantation at the epicenter of the wound after an acute spinal cord injury. It 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.
InVivo’s travails over recent years have included numerous senior staff changes, burgeoning losses and staff layoffs, largely a consequence of the FDA’s 2013 decision to demand that the company’s pilot trial should treat patients in sequence rather than simultaneously. That decision stretched out the pre-approval period, and with it the risk that the money would run out.
The good news of the change of study approval includes expanding the number of allowable clinical sites to 20 (previously six) and broadening the eligibility criteria. The upper end of the age range has been increased from 55 to 65, the spinal cord injury level has been expanded from T3-T11 to T3-T12/L1, the enrollment window has been extended from 10 to 21 days post injury, and the Body Mass Index upper limit has been increased from 35 to 39.
Company comments
Mark Perrin, InVivo’s CEO, said, “We have been working closely with the FDA to optimize enrollment for our acute SCI trial and are very pleased with this approval. We continue to take a proactive approach in broadening such critical variables to expedite subject enrollment.”
Source: InVivo Therapeutics Holdings, Inc.
published: October 29, 2014 in: Clinical Studies/Trials, Spine