Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR) is a leading developer of placenta-based cell therapies. The company's patented PLX (PLacental eXpanded) cells drug delivery platform releases a cocktail of therapeutic proteins in response to a variety of local and systemic inflammatory diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an off-the-shelf product that requires no tissue matching or immune-suppression treatment prior to administration. PLX-PAD comprehensive clinical development plan has been recognized by both the EMA and FDA, targeting a sub-population of 20-million patients of Peripheral Artery Disease (PAD) market. The Company has announced that "a seven year-old girl suffering from an aplastic bone marrow whose condition was rapidly deteriorating is now experiencing a reversal of her condition with a significant increase in her red cells, white cells and platelets following the intramuscular injection of the company's PLacental eXpanded (PLX) cells."
Patients with Aplastic bone marrow have no blood-forming hematopoietic stem cells in their bone marrow.
Professor Reuven Or, Director of Bone Marrow Transplantation, Cell Therapy and Transplantation Research Center at Hadassah Medical Center and the child's physician, explained,
"With her body rejecting all possible treatment -- and with no other options -- we finally turned to Pluristem's PLX cells, which literally saved her life. The results of this unique case indicate that PLX cells may be effective in treating other diseases that affect the bone marrow."
Zami Aberman, Chairman and CEO of Pluristem, commented,
"Pluristem is extremely happy that our PLX cells have helped this little girl. Remarkably, these beneficial effects were seen in the patient after our PLX cells were administered intramuscularly and correlates with the positive effects on the bone marrow when we administered our PLX cells intramuscularly (IM) in animals exposed to toxic levels of radiation. Pluristem now has several data points to indicate that our PLX cells may work for systemic diseases when given locally, away from the target organ, and without a need to give cells intravenously."
In February 2012, Pluristem announced the results of animal studies which suggest that "PLX cells can be potentially effective in treating the life threatening hematopoietic complications associated with Acute Radiation Syndrome (ARS)." In the experiments in question, animals were given PLX cells IM up to 24 hours post irradiation. They demonstrated a recovery of their red cells, white cells, platelets and bone marrow to almost normal levels. This announcement, along with his patient's significant deterioration following two bone marrow transplants, that led Professor Reuven Or to contact Pluristem about the possible compassionate use of PLX cells to treat his young patient.
Pluristem recently received U.S. FDA Clearance "to begin a Phase II clinical trial using the company's proprietary PLX-PAD cell product candidate intramuscularly for the treatment of Intermittent Claudication (IC), a subset of peripheral artery disease (PAD). In April, the Company was awarded a $3.1 Million grant by the Israeli Government, which will be used to help fund R&D and clinical trials."
This news could have positive implications for Athersys who is planning to pursue a phase II registrational style trial in GvHD prevent. There are also implications for Osiris.