U.S. FDA Approves Cost Recovery for PLX-PAD under Expanded Access Program in the Treatment of Critical Limb Ischemia

Pluristem Therapeutics (Nasdaq:PSTI;TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, and WideTrial a privately-held third-party sponsor of authorized Expanded Access Programs (EAPs), today announced that the parties have entered into agreement to initiate an FDA-cleared EAP for Pluristem’s cell therapy product, PLX-PAD, for the treatment of critical limb ischemia (CLI).

As quoted in the press release:

The parties further announced that the FDA has authorized WideTrial to charge payment for the PLX-PAD EAP treatment. Under the terms of the EAP, an initial 100 Rutherford-5 CLI patients who are ineligible for inclusion under Pluristem’s ongoing Phase 3 study protocol, and whose condition is life-threatening, will be enrolled.

“Patients suffering from critical limb ischemia are often unsuitable for revascularization and therefore experience poor clinical outcomes, including amputation. The condition can be fatal if left untreated,” said Yaky Yanay, Co-CEO and President of Pluristem. “We believe the FDA’s decision to approve this Expanded Access Program with cost-recovery for this novel and potentially life-saving cell therapy reflects the Agency’s comfort with the safety profile of PLX-PAD, and recognition of its potential use in treating CLI patients who have few remaining treatment options. As we progress through the EAP, we look forward to generating valuable real world data concurrent with our ongoing 246-patient Phase 3 study that we are currently enrolling in U.S., Europe and Israel. Together, these clinical initiatives are expected to yield a significant body of evidence that we believe will support the safety and efficacy of PLX-PAD and may represent a significant advancement in the treatment of CLI.”

Click here to read the full press release.