Pluristem Therapeutics, Inc. (PSTI - Snapshot Report) recently announced that it has taken possession of its new state-of-the-artfacility after initiating the validation process earlier in Jan 2013.
Pluristem is currently shifting its manufacturing process to this facility. According to Pluristem, this is the world’s first commercial cell therapy manufacturing facility.
Pluristem, headquartered in Israel, develops placenta based cell therapies. The cells from placenta are derived using the company’s proprietary PluriX therapy and are known as PLacental eXpanded (PLX) cells.
The new facility will enable Pluristem to produce large quantities of PLX cells using its patented 3D bioreactor technology. In addition, the new manufacturing facility will allow Pluristem to produce different PLX candidates with the potential capacity of over 150,000 doses on an annual basis.
We note that Pluristem develops and manufactures cell therapy products in collaboration with companies like United Therapeutics
(UTHR - Analyst Report
) or through research and clinical institutions.
Management believes that PLX cells can be effective in supporting bone marrow transplantation and in treating bone marrow suppression from radiation and chemotherapy.
We remind investors that the medical regulatory body for biological medicinal products in Germany, the Paul-Ehrlich-Institute (PEI), has approved the company’s request to conduct a phase II study using PLX-PAD cells in patients suffering from intermittent claudication (IC).
IC is a subset of peripheral artery disease (PAD). The phase II study for IC will be a placebo-controlled trial wherein the safety and efficacy of two doses of PLX-PAD cells will be compared to placebo among 150 patients.
According to the SAGE Group and HCUP 2007 inpatient data, approximately 14 million people in the US suffer from IC, representing a cost of approximately $2.5 billion on an annual basis to the healthcare system.
Pluristem plans to open three clinical sites in Germany where the protocol will be same as in the US where patient enrollment and dosing is in progress. Moreover, the company plans to open clinical sites in Israel, once regulatory approval is received.
Meanwhile, Celgene Cellular Therapeutics, a wholly-owned subsidiary of Celgene Corporation
(CELG - Analyst Report
) 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.