Israel's Pluristem Therapeutics ($PSTI) is back in the spotlight with some positive results for its stem cell therapy in treating patients with a muscle injury, giving the biotech some good news in its up-and-down development path.
In the Phase I/II trial, Pluristem injected its placenta-derived stem cell therapy into patients who suffered gluteus muscle injuries during hip replacement surgery. Using muscle contraction force as an efficacy endpoint, the study found that patients who got a 150-million-cell dose of Pluristem's drug posted a 500% improvement over placebo, while those on a 300-million-cell dose beat out the control arm by 300%. The study met its safety endpoint, as well, the company said.
The treatment, dubbed PLX-PAD, also had a significant effect on muscle volume, Pluristem said, suggesting a bright future for the stem cell therapy in repairing other injuries, CEO Zami Aberman said.
"This was a very important study not only for Pluristem but for the cell therapy industry in general," Aberman said in a statement. "... Based on these results, we intend to move forward with implementing our strategy toward using PLX cells in orthopedic indications and muscle trauma."
The company's shares jumped about 5% to $4.60 on the news, their highest value since 2012. The biotech's shares took a beating in the fall of that year upon the revelation that Pluristem kept quiet about the deaths of two PLX-PAD patients after heralding their treatment as a "breakthrough."
Pluristem is developing its off-the-shelf stem cell platform for a host of ailments, including cardiovascular, orthopedic and pulmonary diseases. The biotech ran into trouble last summer when the FDA put a clinical hold on its most advanced program--a Phase II trial on patients with intermittent claudication--but eventually got back in the agency's good graces after amending the study's recruitment specifications.
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