FDA Grants Fast Track Designation To Pluristem's PLX-PAD For Treatment Of CLI

(RTTNews) - Pluristem Therapeutics Inc. (PSTI) said that the U.S. Food and Drug Administration has granted Fast Track Designation to the company's ongoing Phase III study of PLX-PAD cells for the treatment of Critical Limb Ischemia or CLI in patients ineligible for revascularization.

In Monday's pre-Market trade, PSTI is trading at $1.62, up $0.28 or 20.90%.

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.

Pluristem's Phase III CLI study is ongoing and actively enrolling patients in the U.S. and Europe. The European Medicines Agency (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.