Principal investigator Dr. Travis Dumont performed the implantation earlier this week, 67 hours after the patient’s spinal cord injury happened.
“The implantation procedure of the neuro-spinal scaffold was successful, and the patient is doing well,” Dumont said in prepared remarks. “I look forward to following the patient’s progress going forward.”
“We are pleased at the rate of enrollment into Inspire over the past few months,” InVivo’s chairman & CEO Mark Perrin added. “We now have 11 patients enrolled and in follow up, and with a steady flow of new sites we expect enrollment to increase in the coming months.”
This week, the Cambridge, Mass.-based company also added another clinical site to its trial. The University of New Mexico Hospital marks the 30th clinical site participating in InVivo’s trial.
“I am pleased to be joining the Inspire study and look forward to the opportunity to safely investigate this innovative experimental therapy,” principal investigator Dr. Jeremy Lewis said in a statement.
“We welcome Dr. Lewis and the team at UNMH to the Inspire study,” Perrin said. “As the only Level I trauma center in the entire state of New Mexico, UNMH has a large catchment area that will be helpful for enrolling patients.”
Last week, the 1st U.S. Circuit Court of Appeals upheld the dismissal of a shareholder lawsuit against InVivo Therapeutics, saying that the plaintiff did not do enough to prove that the defendants committed securities fraud. The lead plaintiff, Edmond Ganem, accused InVivo and former CEO Frank Reynolds of inflating stock prices with false or misleading press releases regarding the company’s clinical trials.
The press releases in question date back to April and May 2013, when the company received approval from the FDA for its 1st clinical trial evaluating its biopolymer scaffold for spinal cord injury patients. Ganem alleged that statements in the press releases pertaining to the clinical trials projected timeline were false or misleading, and that InVivo left out details from the FDA’s approval letter such as the watchdog’s recommendation that the company modify its study design so it could serve as the basis for approval of a larger study.
After the 1st press release in April 2013 was published, InVivo’s stock price rose from $2.85 apiece to $3.19.
The appeals court ruled with the district court, concluding that the plaintiffs failed to prove that the omitted details delayed the timeline of the clinical trial.
At the beginning of this month, PixarBio (OTC:PXRB) and CEO Frank Reynolds today upped the ante in their pursuit of InVivo. Reynolds co-founded the regenerative medicine company and led it until his 2013 ouster.
PixarBio and Reynolds made their case for the merger by citing a -41.7% slide in the price of NVIV shares since January last year. The nearly 2,700-word press release detailed the merger, proposing a new entity called Reynolds Therapeutic Corp. The deal is expected to close during the 1st quarter, they said.