Pluristem Therapeutics

Pluristem Therapeutics is an Israeli company engaged in the development of human placental adherent stromal cells for commercial use in disease treatment.[2] According to the company's website, it extracts adult stem cells exclusively from postnatal placentas.[3]

Pluristem Therapeutics Inc.
TypePublic
NASDAQ: PSTI
TASE: PSTI
FWB: PJTA
IndustryBiotechnology
FoundedMay 11, 2001 (2001-05-11)
FounderShai Meretzki
Headquarters
Haifa
,
Israel
Key people
Zami Aberman (CEO, Chairman)
Yaky Yanay (CEO, President)
Revenue₪ 0 (2010)
₪ –30.39 million (2010)
Total assets₪ 27.97 million (2010)
Number of employees
~180
Websitepluristem.com
Footnotes / references
[1]
Pluristem is based in Matam Technology Park in Haifa.

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.[4][5]

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.[6][7] In 2007 the name was changed again, this time to Pluristem Therapeutics Inc.[4] 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.[8] Pluristem was awarded an NIS9 million (US$2.4 million) grant from the Office of the Chief Scientist of Israel in January 2012.[9] 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).[10][11]

In August 2016, Europe's Horizon 2020 Program awarded Pluristem an $8 million grant to cover a portion of its expenses in Europe for Pluristem's Phase III study of PLX-PAD cells in the treatment of critical limb ischemia.[12] In 2016, The US Food and Drug Administration (FDA) gavePluristem Therapeutics, the go-ahead to move forward with its innovative treatment approach for hematopoietic disorders.[13]

Products

Pluristem is in the process of clinically testing the use of its PLX (PLacental eXpanded) cells in Phase I, Phase II and Phase III trials. A Phase III trial of PLX-(PAD)-peripheral arterial disease cells in the treatment of critical limb ischemia has been cleared to start enrolling patients by the U.S. Food and Drug Administration.[14] The Phase III trial has also been cleared by regulators in Germany [15] and the United Kingdom.[16] Pluristem has completed enrollment of 172 patients in January 2017 for a multinational Phase II clinical trial of its PLX-PAD treatment pertaining to intermittent claudication.[16] Top line results are expected early in 2018. On October 27, 2014, it was reported that Case Western Reserve University will conduct a preclinical study of PLX-R18 cells in umbilical cord blood transplants for the treatment of blood cancers and genetic diseases. Results from the study suggest that PLX-R18 is safe and may significantly improve outcomes after bone marrow failure or hematopoietic cell transplantation.[17] The U.S. Food and Drug Administration has also cleared Pluristem to commence patient enrollment in a Phase I trial of its PLX-R18 cells to treat insufficient hematopoietic recovery following bone marrow transplant.[18]

PLX-R18 were initially developed with Professor Raphael Gorodetsky at Hadassah Hospital for the treatment of acute radiation syndrome and enhancement of bone marrow regeneration.[19][20] The U.S. National Institutes of Health is currently evaluating Pluristem's PLX-R18 cells as a treatment for acute radiation syndrome.[21] The dose finding portion of the study was successfully concluded and data showed that PLX-R18 treated subjects had an 85% survival rate compared to the placebo group which had a 50% survival rate. PLX-R18 can serve as a tool for governments to protect their citizens against potential exposure to nuclear radiation.[22]

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.[23][24][25][26][27] She was released from the hospital soon after Pluristem's announcement.[28]

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.[29] This event has been used as a supporting reference to the medical potential of the PLX cells.

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.[13]

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.[30]

In 2020 Pluristem began treating COVID-19 patients with placenta cells known as PLX.[31]

On May 8, 2020 the United States Food and Drug Administration aporoved Pluristem's application to conduct a Phase II study of its PLX cells (as described by HospiMedica.com "PLX cells are allogeneic mesenchymal-like cells that have immunomodulatory properties that induce the immune system’s natural regulatory T cells and M2 macrophages, and thus may prevent or reverse the dangerous overactivation of the immune system. Previous pre-clinical findings of PLX cells revealed therapeutic benefit in the treatment of severe Covid-19 cases"[32]).[33]

See also

References
  1. "TASE Site – Profile". Tel Aviv Stock Exchange. 2011. Retrieved 22 September 2011.
  2. "Pluristem Therapeutics Inc (PSTI:NASDAQ CM)". Bloomberg Businessweek. Retrieved 22 September 2011. The company engages in the development of a pipeline of products, which are derived from human placenta, a non-controversial, non-embryonic, and adult stromal cell source.
  3. "Pluristem: Who we are". Pluristem. Retrieved 22 September 2011. Pluristem has made the strategic decision to work only with adult stem cells, purified from the placenta after birth and, therefore, not subject to ethical or religious controversy.
  4. "PSTI Company Profile". MarketWatch. Retrieved 22 September 2011.
  5. Cohen, Omri (9 April 2008). פלוריסטם דיווחה על הצלחת ניסוי בתרופה לטיפול בשבץ מוחי בעזרת תאי גזע - והמניה קפצה ב-150% [Pluristem reports success in clinical trial involving drug for treating stroke using stem cells - stock soars 150%]. Haaretz (in Hebrew). Retrieved 22 September 2011. מרצקי הקים את פלוריסטם על בסיס פטנטים שפיתח עם פרופ' דב ציפורי ופרופ' אבינועם כדורי ממכון ויצמן.
  6. Ovadia, Avishay (2 July 2003). "Stem cell technology co Pluristem enters Wall Street by back door". Globes. Archived from the original on 24 March 2012. Retrieved 22 September 2011. All the shares in the company have been purchased by a stock market shell by the name of A1 Software, which also recently bought all the patent and know-how rights on the technology of Dr. Shai Meretzki and others at the Technion and the Weizmann Institute relating to stem cell expansion.
  7. "פלוריסיסטם הישראלית נכנסת לוול-סטריט בדלת האחורית: נרכשה על-ידי השלד הבורסאי [A1] Software" [Israeli Pluristem enters Wall Street by back door: Acquired by shell company A1 Software]. Globes (in Hebrew). 1 July 2011. Retrieved 22 September 2011.
  8. "Pluristem renews German collaboration". Globes. 21 August 2012.
  9. "Pluristem wins NIS 9m Chief Scientist grant". Globes. 18 January 2012. Retrieved 9 May 2012.
  10. Solomon, Shoshanna (30 April 2012). "Pluristem Heads for Two-Month High on $3.2 Million Israeli Grant". Bloomberg. Retrieved 9 May 2012.
  11. "Stem cell co Pluristem awarded $3.1m chief scientist grant". Globes. 1 May 2012. Retrieved 9 May 2012.
  12. "Pluristem Attracts in $8 Millon in Funding for Phase III Critical Limb Ischemia (CLI) Study". BioInformant. 9 August 2016.
  13. Press, Viva Sarah. "FDA greenlights clinical trial for new Israeli cell therapy". Israel21c.
  14. Inc, Pluristem Therapeutics (10 January 2017). "Pluristem's Phase III Study of PLX-PAD Cells for the Treatment of Critical Limb Ischemia Cleared by U.S. FDA". GlobeNewswire News Room.
  15. GlobeNewswire (17 January 2017). "Pluristem Receives Clearance From Germany To Initiate Its Multinational Phase III Trial In Critical Limb Ischemia Targeting Early Conditional Marketing Approval". TheStreet.
  16. "Archived copy". Archived from the original on 2018-11-06. Retrieved 2017-05-17.CS1 maint: archived copy as title (link)
  17. "Pluristem Therapeutics (PSTI) Updates on PLX-R18 Development Strategy".
  18. Inc, Pluristem Therapeutics (12 January 2016). "Pluristem Receives U.S. FDA Clearance to Initiate Clinical Trial of PLX-R18 to Treat Insufficient Hematopoietic Recovery Following Bone Marrow Transplant". GlobeNewswire News Room.
  19. Gaberman, Elena; Pinzur, Lena; Levdansky, Lilia; Tsirlin, Maria; Netzer, Nir; Aberman, Zami; Gorodetsky, Raphael (2013-06-18). "Mitigation of Lethal Radiation Syndrome in Mice by Intramuscular Injection of 3D Cultured Adherent Human Placental Stromal Cells". PLOS ONE. 8 (6): e66549. doi:10.1371/journal.pone.0066549. ISSN 1932-6203. PMC 3688917.
  20. Gabison, Yoram (2011-04-12). "Pluristem, Hadassah to Work on Stem Cell Cure for Radiation Damage". Haaretz. Retrieved 2017-08-28.
  21. "Pluristem, NIH to study stem cells to treat radiation syndrome". 26 July 2012 – via www.reuters.com.
  22. "Pluristem's post nuclear exposure study in primates a success". Drug Target Review.
  23. Dey, Esha (9 May 2012). "Pluristem stem cell therapy saves a patient, shares jump". The Baltimore Sun. Reuters. Retrieved 9 May 2012.
  24. "Pluristem stem cells save girl's life". Globes. 9 May 2012. Retrieved 9 May 2012.
  25. איך הצילו תאי הגזע של פלוריסטם את חייה של ילדה בת 7? [How did Pluristem's stem cells save the life of a 7-year-old girl?]. Calcalist (in Hebrew). 9 May 2012. Retrieved 9 May 2012. התאים, שפיתחה חברת פלוריסטם הישראלית, הוזרקו לילדה בת 7 שהגיעה למרכז ההשתלות בבית החולים הדסה עין כרם מרומניה, כשהיא סובלת ממחלה חשוכת מרפא המונעת התחדשות של תאי מח העצם.' 'בעקבות פניית הרופא המטפל לחברת פלוריסטם ובאישור ועדת הלסינקי של משרד הבריאות, קיבלה הילדה, המאושפזת בימים אלה בבית החולים הדסה עין כרם, טיפול ניסיוני בתאי גזע מהשלייה, שפותחו בפלוריסטם.
  26. Wickman, Allie (9 May 2012). "From Earlier, Compassionate Use of Pluristem's PLX Cells Saves the Life of a Child After Bone Marrow Transplantation Failure". Benzinga. Retrieved 9 May 2012.
  27. Sela, Rakefet (9 May 2012). טיפול בתאי גזע מהשלייה של פלוריסטם הציל את חייה של ילדה [Stem cell treatment from Pluristem's placenta saved the life of a girl]. Bizportal (in Hebrew). Retrieved 9 May 2012. 'אנחנו הזרקנו את התאים בפעם הראשונה בעולם לתוך השריר ולא תוך מערכת הדם כמקובל בתרופות תאי גזע, זאת בחיל ורעדה לאחר שראינו תוצאות טובות בניסויים על עכברים.'
  28. Goldman, Dudi (12 May 2012). "Israeli innovation saves Romanian girl's life". Ynetnews. Retrieved 26 May 2012.
  29. "Pluristem stem cells save 3rd bone marrow disease patient". Globes. 5 September 2012. Retrieved 10 September 2012.
  30. "Israeli placental cell therapy could cure radiation sickness". 9 March 2016 – via www.reuters.com.
  31. https://www.timesofisrael.com/israeli-company-hopes-to-treat-coronavirus-patients-with-placenta-cells/
  32. https://mobile.hospimedica.com/?option=com_mobile_article&Itemid=294782293
  33. https://en.globes.co.il/en/article-fda-covid-19-trial-nod-boosts-pluristem-1001327952
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