TEL AVIV (Reuters) - Pluristem Therapeutics had positive 12-month results from Phase I clinical trials for its PLX stem cells for the treatment of critical limb ischemia (CLI), the Israeli stem cell therapy company said on Thursday.
CLI is the end stage of peripheral artery disease (PAD), a degenerative disorder. PAD is an obstruction of blood vessels, usually in the leg, causing pain, difficulty in walking and leading eventually to amputation.
“PLX-PAD cells met all the clinical studies’ protocol endpoints, demonstrating a safe immunologic profile at all dosage levels and found to be potentially effective in treating patients suffering from CLI,” Pluristem said.
Its shares were up 4.4 percent to 9.34 shekels in early trade, compared with a decline in the broader Tel Aviv market.
The trials were conducted under protocols approved by the Food & Drug Administration in the United States and the Paul-Ehrlich-Institute in Germany.
The European Medical Agencies and the FDA require the primary endpoint for CLI pivotal clinical trials to be amputation free survival (AFS) rate, Pluristem said.
Based on the endpoint of AFS at 12 months, it was concluded there is a trend toward efficacy of PLX-PAD cells in the treatment of CLI.
“AFS is the single most important endpoint in CLI clinical trials,” said Edwin Horwitz, president of the International Society for Cellular Therapy and chairman of Pluristem’s Scientific Advisory Board.
“Even though these Phase I trials were not controlled studies, the data collected in these trials on AFS indicate significant potential for PLX-PAD cells in treating CLI patients,” he said.
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Reporting by Tova Cohen; Editing by David Holmes