Massachusetts-based InVivo Therapeutics (OTC:NVIV) saw a major surge on Wall Street on Friday after the market reacted to news that it will soon begin enrolling patients in a U.S. clinical trial of its 1st investigational product, diverting development efforts from its hydrogel drug delivery platform.
The study is taking top priority over other efforts, InVivo said, and the company is searching for strategic partners rather than further developing its hydrogel product on its own. InVivo’s already in talks with "a number of prospective corporate partners," but said it’s too soon to discuss time lines or therapeutic areas.
InVivo plans in the 1st quarter of 2014 to launch a clinical study of its degradable polymer scaffold, evaluating the device in treatment of acute spinal cord injuries. More than 10 clinical sites have already signed confidentiality agreements signaling their interest in participating in the human safety trial and members of an independent data safety monitoring committee have already been selected and have agreed to participate, InVivo reported.
The device maker has already begun pouring resources into its spinal scaffold division, taking engineers and other personnel away from hydrogel product development. By February InVivo expects to have enough scaffold inventory on hand to supply the clinical trial and to be able to better "control the quantity, quality and cost of its scaffold."
"For the scaffold trial, InVivo will submit a filing containing proposed changes to its FDA-approved protocol and supporting documents within the next 10 days," the company reported. "The company believes that approval of the proposed changes would accelerate the progress of its trial by eliminating barriers to enrollment and by expanding the number of sites from at least 3 to as many as 6. For instance, the proposed changes would eliminate a substantial amount of burdensome paperwork and other requirements unnecessary for a safety study."
The FDA has 30 days to respond to InVivo’s new filing, according to regulation.
NVIV shares jumped 55.7% by the end of the day Friday, closing at $1.79, but they’re still far from regaining what they lost. In August NVIV shares sank more than 43% in a single day after the company announced new hurdles in negotiations with the FDA. InVivo announced that, under the terms of its FDA investigational device exemption, each patient enrolled in the upcoming spinal scaffold trial must be followed for 3 months and the company must win agency approval before enrolling the next, meaning it will take InVivo an estimated 21 months to enroll its 5 patients. The delays could push back commercialization for years, analysts warned at the time.
That news had come just a day after InVivo announced the sudden departure of chairman, CEO & CFO Francis Reynolds, who resigned suddenly citing a "medical condition." The company watched its shares drop even further following the sudden resignation of interim CFO Sean Moran, who quit after just 2 weeks in the role. Shares regained a few points after InVivo appointed Gregory Perry as the new CFO, but remained 60% lower than they’d been prior to the C-Suite shuffle.
NVIV shares are up about 3% on the year, but down about 38% on the last 6 months.