Third Critically Ill Patient Successfully Treated with Pluristem's PLX Cells Under Compassionate Use

Pluristem Therapeutics, Inc. announced that the Company’s Placental eXpanded (PLX) cells were successfully administered to a third patient in Hadassah Medical Center; thus, a series of three life saving compassionate use treatments were completed. The outcome of those treatments potentially suggests that the Company’s PLX cells may have significant potential to treat a range of indications of bone marrow diseases.

The latest patient, a 45 year old male, diagnosed with Acute Myeloid Leukemia (AML), a form of blood cancer, underwent chemotherapy to treat the cancerous cells. Treatments with chemotherapy remove cancerous cells as well as normal cells in the bone marrow, leaving the patient needing bone marrow transplantation. The patient received an unrelated (allogeneic) bone marrow transplant. However, he suffered from severe and long standing pancytopenia with associated complications after receiving hematopoietic stem cell transplantations.
 
Due to the patient’s major life threatening condition, 144 days post bone marrow transplantation, PLX cells were injected intramuscularly (IM) at a dose of 600x106 cells, divided into two administrations, one week apart, under compassionate use treatment. No local or systemic side effects were observed. In addition, the patient’s general clinical condition and wellbeing significantly improved, resulting in his release from Hadassah Medical Center.
 
The series of the compassionate use treatments were led by Professor Reuven Or, Director of the Bone Marrow Transplantation and Cancer Immunology at Hadassah Medical Center in Jerusalem. Professor Or received a special permission by the Ministry of Health of the State of Israel, to try treating critically ill patients with bone marrow transplant failure that have no available alternative treatments, with PLX cells. According to Professor Or, “Following three successful treatments, which were conducted for the first time in the world, in Hadassah Medical Center, we can say that PLX cells from the placenta saved the life of patients suffering from bone marrow failure. We are very encouraged by the results and hope that future clinical trials will show the effectiveness of the PLX cells. I believe that the PLX treatment holds huge hope for patients who suffer from different conditions of bone marrow failure and once approved will be available for every patient who needs it.”
 
This is the third patient, out of three treated, to display impressive clinical improvement following the administration of PLX cells. The first two patients responded, four and nine days respectively, after the second PLX cell administration, with improvement of tri-linage hematopoiesis.
 
"We are extremely proud that the hard work, research and testing we have put into producing our PLX cells has now actively contributed towards saving the lives of these severely ill patients," said Zami Aberman, Chairman and CEO of Pluristem. "Additionally, with these three patients, we have data to suggest that our PLX cells may be helpful for rescuing both allogeneic as well as autologous bone marrow transplant failures."

Last month, Pluristem announced that it has filed the necessary documents requesting that the U.S. Food and Drug Administration (FDA) grant orphan drug status to its PLacental eXpanded (PLX) cells for the treatment of aplastic anemia, a critical hematological emergency which is treated by a bone marrow transplantation. It has been estimated that there are 30,000 bone marrow transplants each year in the U.S. alone.