Pluristem Therapeutics

Pluristem Receives Israeli Ministry of Heath Approval to Expand Its Phase II Clinical Trial in Intermittent Claudication to Israel

LogoPluristem Therapeutics Inc., a leading developer of placenta-based cell therapies, announced today that the Israeli Ministry of Health has approved the company’s request to initiate a Phase II study using its PLacental eXpanded (PLX) cells in the treatment of Intermittent Claudication (IC), a subset of peripheral artery disease (PAD). This approval is part of the company’s previously announced strategy to conduct a multi-national study for this indication. The protocol will be the same one used for the study previously approved in the U.S.

Pluristem's PLX Cells Demonstrate Efficacy in Preclinical Study for Graft Versus Host Disease

LogoPluristem Therapeutics Inc., a leading developer of placenta-based cell therapies, announced today that the company’s PLacental eXpanded (PLX) cells demonstrated efficacy in a preliminary animal experiment for the treatment of Graft versus Host Disease (GvHD) following bone marrow transplantation (BMT). The results showed that PLX cells, regardless of their administration route, intravenous (IV) or intramuscular (IM), demonstrated a statistically significant improvement (p<0.05) in the GvHD score. Following interest from leading medical institutions, Pluristem is investigating a potential cooperation to bring this indication to a clinical trial. GvHD may occur after BMT when patients receive bone marrow tissue or cells from a donor and these newly transplanted cells regard the recipient's body as foreign, attacking the recipient's body. The global incidence of acute GvHD ranges from 26% to 34% in recipients of fully matched sibling donor grafts, to 42% to 52% in recipients of matched unrelated donor grafts.

FDA Lifts Clinical Hold of Pluristem Therapeutics Inc's Phase II Intermittent Claudication Study

LogoPluristem Therapeutics Inc, a leading developer of placenta-based cell therapies, announced today that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold previously placed on the Company's U.S. Phase II Intermittent Claudication (IC) study (IND 15038) on June 4, 2013.

Pluristem Granted Key U.S. Patent for the Treatment of Peripheral Artery Disease

LogoPluristem Therapeutics Inc., a leading developer of placenta-based cell therapies, announced today that the company has completed a major step in its intellectual property strategy: the United States Patent and Trademark Office has granted the Company U.S. Patent 8,529,888. This patent, the 26th issued to the Company, covers methods for the treatment of peripheral artery disease with placental-derived adherent stromal cells. The treatment for PAD is one of Pluristem’s primary drug development areas. Based on priority date, the expected expiration date of this patent is at least until 2028.

Tendon Injuries Treated with Pluristem's PLX Cells Demonstrate Favorable Properties

LogoPluristem Therapeutics Inc., a leading developer of placenta-based cell therapies, announced the results of a pre-clinical trial using the Company’s PLacental eXpanded (PLX) cells in tendon injury. Dr. Scott Rodeo and his orthopedic research team at New York’s Hospital for Special Surgery (HSS) studied the effects of PLX cells on rat patellar tendons that had sustained collagenase-induced injuries.

Pluristem Awarded a $3.3 Million Grant by Israeli Government

LogoPluristem Therapeutics Inc., announced that its wholly owned subsidiary, Pluristem Ltd., has received approval for a 12 million New Israeli Shekels (approximately $3.3 million) grant from the Office of the Chief Scientist (OCS) within the Israeli Ministry of Economy. Once received, the grant will be used to cover R&D expenses for the period January 2013 to December 2013.

U.S. National Institutes of Health Recommend to Expand Its Scope of Research in the Development of Pluristem's PLX-RAD Cells for the Treatment of Acute Radiation Syndrome

LogoPluristem Therapeutics Inc, a leading developer of placenta-based cell therapies, announced today that the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, has recommended to Pluristem that NIAID expand the scope of its ongoing animal research using PLX-RAD cells for the treatment of acute radiation syndrome (ARS).

Pluristem Completes Enrollment for Phase I/II Muscle Injury Trial

LogoPluristem Therapeutics Inc., a leading developer of placenta-based cell therapies, announced today it has completed the target enrollment in a randomized, double-blinded, placebo controlled Phase I/II clinical trial to assess the safety and efficacy of its PLacental Expanded (PLX) cells for the treatment of traumatized muscles. All patients have been treated with PLX-PAD cells or placebo and are currently in the follow up stage of the trial.

Pluristem's South Korean Partner Files IND with Korean FDA for PLX Cells

LogoOn the heels of announcing its strategic partnership agreement with Cha Bio&Diostech on June 26th, Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapies, announced today that Cha Bio&Diostch “Cha” has filed its first investigational new drug (IND) application for Pluristem’s PLacental eXpanded (PLX) cells with the Korea Food and Drug Administration (FDA). This IND is for the use of PLX-PAD in the treatment of intermittent claudication (IC) and mirrors the clinical protocols implemented by Pluristem in its U.S. FDA Phase II IC clinical trial in the United States.

Pluristem Enters Into Strategic Partnership and Licensing Agreement with Cha Bio&Diostech

LogoPluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR) today announced that its wholly owned subsidiary, Pluristem Ltd., has entered into an exclusive out-license and strategic partnership agreement with Cha Bio&Diostech for the use of Pluristem’s PLacental eXpanded (PLX) cells for peripheral artery disease (PAD), specifically in two indications: the treatment of Critical Limb Ischemia (CLI), and Intermediate Claudication (IC) in South Korea.