Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) has received permission from Germany's Paul-Ehrlich-Institute (PEI), the country's medical regulatory agency, to commence a Phase I/II clinical trial to assess the safety and efficacy of its placental stem cell (PLX) therapy for the regeneration of injured gluteal musculature following total hip replacement. The PLX cells will be administered by intramuscular injections.
The trial will include 18 patients scheduled to undergo a total hip replacement. Patients will receive either PLX cells or a placebo. Each patient will be monitored for 12 months.
Pluristem said that muscle damage is a common result of hip replacement surgery, which is increasing in Europe and other developed nations as populations age. 150 per 100,000 people undergo hip replacement surgery in Europe a year, and procedures rose by one thid in 1998-2008. It estimates there are 300,000 total and partial hip replacements in the US each year.
Pluristem chairman and CEO Zami Aberman said, "This is an important new indication for PLX cells, as beyond potentially showing safety and efficacy in muscle regeneration after hip replacement surgery, this opens PLX cells to the possibility of addressing large new markets in sports injury treatment and muscular regenerative medicine. We are very pleased with the growing number of new indications and new clinical trials currently initiated for our PLX cells around the world."
Today's announcement comes one day after Pluristem reported that its PLX cells cured an Israeli woman suffering from lymphoma, who had not responded to chemotherapy or bone marrow transplants. This was the second successful treatment of a patient suffering from bone marrow failure in three months.
Pluristem's share price rose 14.8% on Nasdaq yesterday, following the report, to $3.80, giving a market cap of $170 million. The share price fell 2.1% in morning trading on the TASE today to NIS 15.66, after rising 22.4% yesterday.
Published by Globes [online], Israel business news - www.globes-online.com - on August 7, 2012
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