Invivo Therapeutics (NVIV) Announces INSPIRE Trial Temporary Enrollment Halt Following Patient Death

July 31, 2017 8:04 AM EDT
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InVivo Therapeutics Holdings Corp. (NASDAQ: NVIV) today provided an update on the progress of the company’s 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), which is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold™ for the treatment of complete thoracic spinal cord injury (SCI). The primary endpoint of the study is defined as improvement in ASIA Impairment Scale (AIS) grade from baseline at the six-month visit. The study update includes:

Update on Patient Conversions

  • A patient improved from complete AIS A SCI to motor incomplete AIS C SCI at the one-month visit.
  • A second patient improved from complete AIS A SCI to sensory incomplete AIS B SCI at the six-month visit.
  • Six of 11 patients (54.5 %) have had an AIS grade improvement at the six-month primary endpoint visit. The following table provides a summary of all patients in follow-up:

Patients Currently in Follow-Up

Patient Group

Number of Patients

Converted at six-month visit 6
Converted, less than six months of follow-up 1
Not converted at six-month visit 5
Not converted, less than six months of follow-up 4

TOTAL

16 patients in follow-up
  • Of the seven conversions, four are AIS C conversions at this time, meaning these four patients have recovered both sensory and motor function. These conversions to AIS C have occurred as early as one month and as late as 24 months after Neuro-Spinal Scaffold™ implantation. Having assessments of motor improvements occurring one or two years post-implantation is uncommon and may be indicative of prolonged neural repair.

One of the two patients who recently converted was implanted with the Neuro-Spinal Scaffold™ in January 2017 by Travis Dumont, M.D, Director of the Neurovascular Program and Principal Investigator at Banner – University Medical Center Tucson in Tucson, AZ. This patient initially converted from complete AIS A SCI to sensory incomplete AIS B SCI at two months but reverted back to AIS A at three months. Subsequently, at the six-month visit, the patient converted from AIS A to AIS B. This conversion to AIS B at six months will be included in the primary endpoint analysis of AIS improvements from baseline at the six-month visit.

Dr. Dumont said, “This patient has demonstrated motor improvements from baseline assessments, and the conversion to AIS B at the six-month visit is encouraging.”

The other patient who recently converted was implanted in June 2017 by Drs. Dan Altman, Nestor Tomycz, and Terrence Julien at Allegheny General Hospital in Pittsburgh, PA. The patient converted from complete AIS A SCI to motor incomplete AIS C SCI between the hospital discharge and one-month visits. At baseline, the patient was assessed to have a T6 neurological level of injury (NLI). In a large European registry*, only 2.9% of patients with a T6-T9 NLI were reported to improve to AIS C or better by one month after injury. This is the second patient in the INSPIRE study to have reached AIS C motor incomplete classification at the one-month evaluation and the fourth patient in the INSPIRE study to have reached AIS C motor incomplete classification.

Dr. Julien, System Co-Director of Minimally Invasive Spine Surgery and Principal Investigator, said, “A conversion to AIS C at one month for a patient with a T6 level of injury is rare. I look forward to continuing to track the patient’s progress and hope that the patient continues to show signs of neurological recovery.”

Trial Status Update: Temporary Enrollment Halt

The most recent patient to enroll into the INSPIRE study, who was implanted in late June 2017, passed away suddenly at a rehabilitation facility following discharge from the hospital. The cause of death was deemed by the Principal Investigator at the site to be unrelated to the Neuro-Spinal Scaffold™ or implantation procedure. This represents the third death in INSPIRE to date, all of which have been deemed to be unrelated to the investigational product or implantation procedure by each respective site’s Principal Investigators.

The company has elected, based in part on discussions with the company’s independent Data Safety Monitoring Board, to implement a temporary halt to enrollment as it engages with the Food and Drug Administration (FDA) to determine whether any changes to patient enrollment criteria related to patients who may have a higher mortality risk or other study modifications are deemed necessary.

As a result of the temporary enrollment halt, the company anticipates completing INSPIRE enrollment in the first half of 2018 and submitting a Humanitarian Device Exemption (HDE) application in the second half of 2018.

Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said, “Our thoughts and condolences are with the patient’s loved ones at this difficult time. We remain committed to monitoring carefully all aspects of the INSPIRE study to ensure the ongoing safety of subjects. Regarding the enrollment halt, we are working toward an expeditious resolution. Based on the compelling clinical results to date, particularly the two most recent AIS conversions, we hope to reopen enrollment as soon as possible.”



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