Pluristem Therapeutics

Corporate history

Pluristem was founded in 2001 by Shai Meretzki of the Technion, who made use of a stem cell patent which was developed during his Ph.D studies at The Rappaport Faculty Of Medicine, Technion, under the supervision of Dr. Shosh Merchav, together with Professors Dov Zipori and Avinoam Kadouri from the Weizmann Institute of Science. In 2003, the NASDAQ-listed shell company A1 Software acquired all shares and patents belonging to Pluristem and changed its name to Pluristem Life Systems. In 2007 the name was changed again, this time to Pluristem Therapeutics Inc. Pluristem's shares are traded on the NASDAQ exchange and the Tel Aviv Stock Exchange, as well as on the Frankfurt Stock Exchange.

In 2007 Pluristem entered into a collaborative research agreement with the Charité medical school in Berlin for a period of five years. In 2012 Pluristem announced that the agreement had been renewed until 2017. Pluristem was awarded an NIS9 million (US$2.4 million) grant from the Office of the Chief Scientist of Israel in January 2012. In April of the same year the company announced the receipt of an additional grant from the Chief Scientist, this time of NIS11.8 million (US$3.2 million).

Products

Pluristem is in the process of clinically testing the use of its PLX (PLacental eXpanded) cells to treat peripheral arterial disease (PAD). In April 2012 Pluristem announced that the U.S. Food and Drug Administration authorized Phase II clinical trials for its PLX-PAD treatment appertaining to intermittent claudication. On October 27, 2014, it was reported that Case Western Reserve University will conduct a preclinical study of PLX-RAD cells in umbilical cord blood transplants for the treatment of blood cancers and genetic diseases.

The USFDA has conferred orphan drug status on Pluristem's PLX cells for the treatment of Buerger's disease (2011) and aplastic anemia (2013).

Human applications

In May 2012 Pluristem reported that its experimental PLacental eXpanded cells were injected into the muscles of a 7-year-old Romanian girl undergoing treatment for bone marrow aplasia disease at the Hadassah Medical Center in Jerusalem. The girl had undergone two allogenic stem cell transplants since being admitted in August 2011, both of which failed to improve her condition. Two months thereafter, with the patient's condition deteriorating rapidly, the Director of Bone Marrow Transplantation, Cell Therapy and Transplantation Research Center at Hadassah felt that all available options had been exhausted and turned to Pluristem's PLX cells. The Helsinki committee at Israel's Ministry of Health approved the procedure under compassionate use. According to Pluristem CEO Zami Aberman, it was the first time ever that stem cells were injected into the muscle rather than into the body's blood system. Pluristem announced that the treatment led to a significant increase in the girl's red cells, white cells and platelets, effecting a reverse in her condition. She was released from the hospital soon after Pluristem's announcement.

In September 2012 Pluristem reported saving the life of a third bone marrow disease patient using its PLacental eXpanded cell treatment, again at Jerusalem's Hadassah Medical Center and again under the terms of compassionate use. The 45-year-old patient suffered from acute myeloid leukemia and pancytopenia, and his condition was determined to be life-threatening. After two intramuscular injections of Pluristem's PLX cells, the patient's condition improved significantly and he was released from the hospital.

In January 2016, the US Food and Drug Administration (FDA) gave Pluristem Therapeutics, the go-ahead to move forward with its innovative treatment approach for hematopoietic disorders. Pluristem was given permission to begin its Phase I trial of PLX-R18 cells to treat incomplete hematopoietic recovery following Hematopoietic Cell Transplantation. The clinical trial is expected to begin in the coming months.

Later in 2016, Pluristem announced it had partnered with Japan's Fukushima Medical University to test its placental-derived cellular therapy for radiation treatment and has been asked to join the United States National Institute of Allergy and Infectious Diseases program.