In another blow to MSCs developer, Pluristem terminates a failed lead program
A tough year for mesenchymal stem cell companies just got tougher.
Pluristem, the NASA-allied Israeli stem cell biotech, announced Monday that a data monitoring committee determined the Phase III trial for a lead program wouldn’t meet the primary endpoint. The company will abandon the effort, which had focused on preventing amputations in people with critical limb ischemia.
They blamed a low number of amputations in the placebo group, which they argued made it more difficult to prove that their stem cells were providing a benefit.
Pluristem’s stock $PSTI was cut nearly in half on the news, falling from $11.46 to $6.60 pre-market.
The hit makes Pluristem the second mesenchymal developer to take a beating on the market this year, after the Australia-based Mesoblast $MESO saw shares drop off in August. They had risen in anticipation of an FDA decision on their graft-versus-host-disease application, and fell when the agency delivered a CRL.
Mesoblast recovered, though, after Novartis bought into their effort to apply their stem cells in people with severe Covid-19 and other patients with acute respiratory distress syndrome.
Pluristem has its own Covid-19 program — one of over a dozen such efforts in the US to use stem cells as a way of modulating the overactive immune response in severe patients — and CEO Yaky Yanay sought to turn attention to it on a call with investors Wednesday morning.
He noted that they were likely to complete enrollment in the first quarter of 2021 and announce data around 60 days later. He also pointed to readouts next year in muscle regeneration following hip fracture and in patients experiencing incomplete hematopoietic recovery following hematopoietic cell transplantation.
Asked, though, about their work in intermittent claudication, a condition that affects the arteries and can progress to critical limb ischemia, Yanay made clear they were moving on. He said that they would devote their efforts to indications where they believe they have the best chance of succeeding.
But not everyone agrees that Covid is one of those indications. Mesenchymal stem cells, short-lived stem cells that can pass through the body safely, have been in the clinic for two decades in a range of diseases, but researchers have struggled to show benefits in large, placebo-controlled studies
“In a way, it’s like giving aspirin for Covid,” Jeanne Loring, an early stem cell pioneer and a professor emeritus at the Scripps Research Center for Regenerative Medicine told Endpoints News in September. “It’s not going to hurt them, but the chances of it helping them? It’ll be a miracle.”
Social image: Yaky Yanay, Pluristem (Twitter)