Pluristem Therapeutics, a developer of placenta-based cell therapy products, announced that the FDA has granted Fast Track Designation to the company’s ongoing phase III study of PLX-PAD cells for the treatment of Critical Limb Ischemia (CLI) in patients ineligible for revascularization. The FDA’s Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and unmet medical needs. With Fast Track Designation, there is an increased possibility for a priority review by the FDA of PLX-PAD cells for the treatment of CLI.
“We are extremely pleased with the FDA’s decision to grant Fast Track Designation to PLX-PAD in the treatment of CLI. Up to 40% of patients with CLI are ineligible for revascularization and are at high risk of amputation and death within the first year of diagnosis. This disease takes a heavy toll on patients and their families, while the cost of treating CLI in the U.S. alone is estimated at over $25 billion per year. We are working tirelessly to provide a cell therapy that will address this severe unmet medical need” said Zami Aberman, Chairman and Co-CEO of Pluristem.
“Regulators in some of the largest healthcare markets in the world are now in alignment regarding the need for accelerated approval pathways for our cell therapy product in the treatment of CLI. Programs like the Fast Track Designation offer real hope for patients battling this disease and we look forward to accelerating the path to market for PLX-PAD,” stated Pluristem President and Co-CEO Yaky Yanay.
Pluristem’s phase III CLI study is ongoing and actively enrolling patients in the U.S. and Europe. The EMA has included PLX-PAD in its Adaptive Pathways program. Positive results from an interim analysis following treatment of half (125) of the study’s population may lead to early conditional marketing authorization. In Japan, the Pharmaceuticals and Medical Devices Agency (PDMA) has accepted PLX-PAD for the treatment of CLI into its accelerated regulatory pathway for regenerative therapies and has agreed on the design of a single study (N=75) that may lead to early conditional marketing approval and reimbursement.