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

Patient with Blood Cancer, Acute Myeloid Leukemia, Experienced Improved Clinical Condition and Released From Hospital

Pluristem Therapeutics, Inc. a leading developer of placenta-based cell therapies, announced recently that the Company’s Placental eXpanded (PLX) cells were successfully administered to a third patient at Hadassah Medical Center, following two other life saving compassionate use cases. The outcome of all three treatments 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. Chemotherapy treatments remove cancerous cells as well as normal cells in the bone marrow, leaving the patient needing bone marrow transplantation. This 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 life threatening condition, 144 days after bone marrow transplantation, PLX cells were injected intramuscularly (IM) at a dose of 600X10 cells, divided in 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 three 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 special permission by the Ministry of Health of the State of Israel to treat critically ill patients suffering from bone marrow transplant failure that have no available alternative treatments, with PLX cells.

According to Professor Or, “Following three successful treatments, conducted for the first time in the world at Hadassah Medical Center, we can confidently say that the placental-derived PLX cells saved the life of these patients suffering from bone marrow failure. I believe that PLX treatment holds enormous potential for patients who suffer from various conditions of bone marrow failure, and I look forward to the day the treatment will be available for every patient who needs it.”

All three patients have displayed 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 have now actively contributed towards saving the lives of these severely ill patients," said Zami Aberman, Chairman and CEO of Pluristem. "Additionally, we now 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 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 bone marrow transplantation. It has been estimated that there are 30,000 bone marrow transplants each year in the U.S. alone.

About Pluristem Therapeutics Inc.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company's patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic 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 prior to administration. Pluristem is focusing on the use of PLX cells administered locally to treat systemic diseases and potentially obviating the need to use the intravenous route.

Data from two phase I studies indicate that Pluristem’s first PLX product candidate, PLX-PAD, is safe and potentially effective for the treatment of end stage peripheral artery disease when given locally. Additionally, Pluristem is developing PLX-PAD for cardiac ischemia, PLX-BMP for Acute Radiation Exposure, Bone Marrow Transplant Failure and Chemotherapy induced Bone Marrow Aplasia, PLX-ORTHO for orthopedic indications and PLX-PAH for Pulmonary Hypertension in collaboration with United Therapeutics. Pluristem’s pre-clinical animal models have demonstrated PLX cells are also potentially effective in other inflammatory and ischemic indications, including diastolic heart failure, inflammatory bowel disease, neuropathic pain and pulmonary fibrosis.

Pluristem has a strong patent portfolio, GMP certified manufacturing and research facilities as well as strategic relationships with major research institutions. For more information, visit www.pluristem.com.