Pluristem’s PLX Cells Satisfy Prerequisites for Fast-Track Approval in Japan
Pluristem Therapeutics announces that Japan’s Pharmaceuticals and Medical Devices Agency agreed with its methods for the manufacture of PLX-PAD cells.
Pluristem Therapeutics, a developer of placenta-based cell therapies headquartered in Israel, announced on May 13, 2015 that Japan’s Pharmaceuticals and Medical Devices Agency (PDMA) agreed with the “proposed quality and large-scale manufacturing methods for PLX-PAD cells for use in clinical trials,” according to a press release. The agreement could lead Pluristem’s PLX cells to Japan’s Accelerated Pathway for Regenerative Medicine, initiating Phase I/II studies in critical limb ischemia. Japan’s Accelerated Pathway for Regenerative Medicine, which went into effect in November 2014, grants therapies conditional, time-limited approval for marketing and makes them eligible for reimbursement once safety and efficacy is determined.
“Pluristem is emerging as an early leader in the industry’s push to enter Japan’s newly established accelerated regulatory pathway. It is our hope that the PDMA will approve our application for a Phase I/II clinical study of PLX cells in critical limb ischemia via the Accelerated Pathway,” said Zami Aberman, CEO of Pluristem, in a press release.
Source: Pluristem Therapeutics
