Manufacturing Approval for Pluristem Facility - Analyst Blog
Pluristem Therapeutics, Inc. ( PSTI ) develops placenta-based cell therapies in collaboration with companies like United Therapeutics ( UTHR ) or through research and clinical institutions. The cells from placenta are derived using the company's proprietary PluriX therapy and are known as PLX cells. Pluristem's first candidate in development, PLX-PAD, is intended to treat peripheral artery disease (PAD).
The company recently received approval from the Paul-Ehrlich-Institute (PEI), Germany's health authority, for its state-of-the-art facility.
The new facility is fully automated and equipped with proprietary 3D cell expansion manufacturing platform. The new facility allows Pluristem to efficiently produce over 150,000 doses of PLX cells annually.
The approval of this new facility will support Pluristem's ongoing trials and will enable it to enter into multiple clinical trials using its expanded manufacturing capabilities. Pluristem expects to obtain approval from other regulatory authorities as well including the U.S. Food and Drug Administration (FDA).
Last week, Pluristem released positive top-line results from a phase I/II trial evaluating the safety and efficacy of PLX-PAD cells in the treatment of muscle injury. The study met both the primary and secondary endpoints. The results from the trial showed that PLX-PAD cells were safe and statistical significance was reached for the primary efficacy endpoint.
The results indicated that PLX cells might be efficacious in the treatment of orthopedic injuries including muscles and tendons.
We are encouraged by the recent bout of news at Pluristem which bodes well for future clinical trials - the approval of a new facility and positive results from the clinical trial demonstrating the efficacy of PLX cells in the treatment of muscle injury.
Meanwhile, Celgene Cellular Therapeutics, a wholly owned subsidiary of Celgene Corp. ( CELG ), is also doing research on stem cells derived from the human placenta as well as from the umbilical cord for the treatment of different diseases.
Pluristem currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the same sector is Actelion Ltd. ( ALIOF ) with a Zacks Rank #1 (Strong Buy).
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.