After temporarily halting enrollment in the INSPIRE study last week, InVivo announced today the company is reviewing recommendations from the FDA and working toward re-opening the clinical trial. The company also reported a $6.3 million net loss for the second quarter, although CEO and Chairman Mark Perrin reported the company was making "significant progress."
"During the quarter, we enrolled four more patients into INSPIRE, and we now have 16 patients in follow-up," he said. "One of these patients improved from complete AIS A SCI to motor incomplete AIS C SCI at the one-month visit. We also announced that two patients who had previously converted to AIS B had been assessed to have converted to AIS C at their 12- and 24-month visits, respectively."
However, despite the progress with some enrollees and an overall 54.5 percent conversion rate at the six-month endpoint, the company decided to halt enrollment when the third patient died last week. The onsite clinical investigator determined the death was unrelated to InVivo's Neuro-Spinal Scaffold, which the study examines. InVivo engaged the FDA to determine whether protocol changes would be necessary, and the FDA responded.
"We are working on assessing the recommendations and formulating a response that will include a protocol amendment," said Mr. Perrin. "At this time, our primary focus at InVivo is re-opening enrollment in INSPIRE as quickly as possible so that we can continue to make progress toward our goal of redefining the life of the spinal cord injury patient."
The company also released its second quarter financial report. Here are four things to know:
1. InVivo reported $6.3 million in net loss, up from $5.2 million in the same period last year. The increase was driven by additional operating expenses tied to research and development as well as larger general and administrative costs.
2. Cash, cash equivalents and marketable securities reached $21.8 million for the quarter.
3. Six months net loss reached $12.7 million, up slightly from the same period last year.
4. The net loss was also affected by a non-cash gain on the derivative warrant liability, reflecting a change in the fair market value of derivative warrant liability.