InVivo Therapeutics Holdings Corp. (NVIV) announced that the company has received supplemental Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) for a second pivotal clinical study of the company’s Neuro-Spinal Scaffold™ in patients with acute spinal cord injury (SCI). The 20-patient (10 subjects in each study arm), randomized, controlled trial is designed to enhance the existing clinical evidence for the Neuro-Spinal Scaffold™ from the company’s single-arm 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 definition of study success is that the difference in the proportion of subjects who demonstrate an improvement of at least one grade on AIS assessment at the six-month primary endpoint follow-up visit between the Scaffold Arm and the Comparator Arm must be equal to or greater than 20%.
InVivo recently reported that seven of 16 (43.8%) evaluable patients in the INSPIRE study experienced an improvement in AIS grade from baseline at six months compared to the Objective Performance Criterion (study success definition) of 25% of patients. Of these seven patients, three of five individuals who had converted from AIS A SCI (complete) to AIS B SCI (sensory incomplete) in the first six-month period of follow-up subsequently further improved to AIS C SCI (motor incomplete) within 12 to 24 months, including a recent patient who converted from AIS B to AIS C at the 12-month exam in January 2018.
“We are pleased to announce the FDA’s approval of this randomized, controlled trial and appreciate the agency’s collaboration with us on the development of a protocol to address the substantial unmet needs in this patient population. We believe this now sets us in a direction towards a clear and efficient path to approval under the HDE regulatory program, and we are focused on engaging with the investment community and exploring financing mechanisms to support this approved randomized study,” said Richard Toselli, M.D., President and Chief Executive Officer of InVivo. He adds, “We look forward to providing further updates as we obtain clarity on financing and the timing for our second pivotal trial.”
“InVivo has achieved important milestones with the FDA over the past seven months under Dr. Toselli’s leadership,” stated Ann Merrifield, InVivo’s Chair of the Board of Directors. “I wish to commend Rich and his team in their continuing interactions with the FDA and their strategy for advancing this important program in the clinic.”