Rare Daily Staff
Pluristem Therapeutics said it is ending the late-stage study of its experimental PLX-PAD therapy for critical limb ischemia after an independent data monitoring committee performed an interim analysis of the phase 3 study and concluded it was unlikely to meet its primary endpoint.
Pluristem shares fell to a low of $6.21 from a previous close of $11 in response to the news.
Critical limb ischemia (CLI) is an advanced stage of peripheral artery disease (PAD). CLI Patients suffer from severe pain at rest, skin wounds, tissue necrosis and poor quality of life with a high risk of leg amputation and death. Up to 35 percent of patients are unsuitable for revascularization and experience up to a 40 percent amputation rate at one year.
PLacental eXpanded (PLX) cells are placenta-derived, mesenchymal-like adherent stromal cells that are designed to be administered to patients without the need for tissue or genetic matching. These cells release soluble biomolecules, such as cytokines, chemokines, and growth factors, which act in a paracrine or endocrine manner to facilitate healing of damaged tissue by stimulating the body’s own regenerative mechanisms. PLX-PAD cells respond to chemical distress signals from tissues that have been damaged by ischemia (inadequate blood flow), muscle trauma, or inflammation, by secreting a range of therapeutic proteins that trigger the body’s own repair mechanisms. These secreted proteins drive the body to grow collateral blood vessels to bring oxygenated blood to ischemic tissue, heal damaged muscle, and dampen inflammation. PLX-PAD cells also modulate the immune system, which plays a central role in the body’s response to injuries.
The data monitoring committee advised the company that the study population has experienced a substantially low number of events (major amputation of the index leg or death), different than what is known in clinical medicine for the rate of these events in this patient population. The lower than anticipated event rate in the placebo group reduced the statistical power of the study to meet its primary endpoint.
PLX-PAD was well tolerated, and no significant safety concerns were raised during the study.
“We are deeply disappointed by the outcome of the CLI interim analysis,” said Yaky Yanay, president and CEO of Pluristem. “In light of the DMC’s recommendation, we decided that it would be in the best interests of the company and its shareholders to terminate the CLI study and focus our resources and efforts on our other lead indications.”
Photo: Yaky Yanay, president and CEO of Pluristem
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