Pluri Inc.

Last updated
Pluri Inc.
FormerlyPluristem Therapeutics
Type Public
Nasdaq:  PLUR
TASE:  PLUR
Industry Biotechnology
FoundedMay 11, 2001;21 years ago (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
Website pluri-biotech.com
Footnotes /references
[1]

Pluri Inc., formerly 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]

Contents

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 December 2020, the Genesis Prize and Start-up Nation Central named Pluri as one of the winners in a competition among Israeli high-tech and biotechnology companies. [8]

In July 2022, the company changed its name from Pluristem Therapeutics to Pluri Inc. and its ticker symbol to PLUR from PSTI. [9]

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. [10] The Phase III trial has also been cleared by regulators in Germany [11] and the United Kingdom. [12] 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. [12] Results from the study suggest that PLX-R18 is safe and may significantly improve outcomes after bone marrow failure or hematopoietic cell transplantation. [13] 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. [14]

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. [15] [16] The U.S. National Institutes of Health is currently evaluating Pluristem's PLX-R18 cells as a treatment for acute radiation syndrome. [17] 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. [18]

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. [19] [20] [21] [22] [23] She was released from the hospital soon after Pluristem's announcement. [24]

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. [25] 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. [26]

In 2020 Pluristem began treating COVID-19 patients with placenta cells known as PLX. [27]

On May 8, 2020, the United States Food and Drug Administration approved 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" [28] ). [29]

Collaboration and grants

Since 2007, Pluri has been engaged in a collaborative research agreement with the Charité – Berlin University of Medicine. [30]

Pluri has been awarded several grants from the Israel Innovation Authority (IIA), formerly named the Office of the Chief Scientist. [31] [32] [33]

Since 2016, the European Union's Horizon 2020 program has awarded millions of euros in grants to Pluri's clinical and research programs, including its Phase III study to treat critical limb ischemia (CLI) and its Phase III study to treat muscle injury following surgery for hip fracture. [34] [35] [36]

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. [37]

Since 2020, Pluri has been part of the CRISPR-IL consortium, funded by the Israel Innovation Authority. The partnership seeks to develop genetically edited PLX cells tailored for treatment of indications with unmet needs. [38]

In January 2022, Pluri announced a collaboration with Israel's largest food producer, Tnuva, to produce sustainable cultured food. [39] [40] In recognition of their partnership, Pluri and Tnuva participated in the Nasdaq closing bell ceremony in March 2022. [41] The company intends to present its technological proof of concept in 2022, with the goal of launching its first raw cultured meat product in 2023. [39]

See also

Related Research Articles

<span class="mw-page-title-main">Stem cell</span> Undifferentiated biological cells that can differentiate into specialized cells

In multicellular organisms, stem cells are undifferentiated or partially differentiated cells that can differentiate into various types of cells and proliferate indefinitely to produce more of the same stem cell. They are the earliest type of cell in a cell lineage. They are found in both embryonic and adult organisms, but they have slightly different properties in each. They are usually distinguished from progenitor cells, which cannot divide indefinitely, and precursor or blast cells, which are usually committed to differentiating into one cell type.

Aplastic anemia is a disease in which the body fails to make blood cells in sufficient numbers. Blood cells are produced in the bone marrow by stem cells that reside there. Aplastic anemia causes a deficiency of all blood cell types: red blood cells, white blood cells, and platelets.

<span class="mw-page-title-main">Bone marrow</span> Semi-solid tissue in the spongy portions of bones

Bone marrow is a semi-solid tissue found within the spongy portions of bones. In birds and mammals, bone marrow is the primary site of new blood cell production. It is composed of hematopoietic cells, marrow adipose tissue, and supportive stromal cells. In adult humans, bone marrow is primarily located in the ribs, vertebrae, sternum, and bones of the pelvis. Bone marrow comprises approximately 5% of total body mass in healthy adult humans, such that a man weighing 73 kg (161 lbs) will have around 3.7 kg (8 lbs) of bone marrow.

<span class="mw-page-title-main">Hematopoietic stem cell transplantation</span> Medical procedure to replace blood or immune stem cells

Hematopoietic stem-cell transplantation (HSCT) is the transplantation of multipotent hematopoietic stem cells, usually derived from bone marrow, peripheral blood, or umbilical cord blood in order to replicate inside of a patient and to produce additional normal blood cells. It may be autologous, allogeneic or syngeneic.

<span class="mw-page-title-main">Graft-versus-host disease</span> Medical condition

Graft-versus-host disease (GvHD) is a syndrome, characterized by inflammation in different organs. GvHD is commonly associated with bone marrow transplants and stem cell transplants.

<span class="mw-page-title-main">Hematopoietic stem cell</span> Stem cells that give rise to other blood cells

Hematopoietic stem cells (HSCs) are the stem cells that give rise to other blood cells. This process is called haematopoiesis. In vertebrates, the very first definitive HSCs arise from the ventral endothelial wall of the embryonic aorta within the (midgestational) aorta-gonad-mesonephros region, through a process known as endothelial-to-hematopoietic transition. In adults, haematopoiesis occurs in the red bone marrow, in the core of most bones. The red bone marrow is derived from the layer of the embryo called the mesoderm.

Metachromatic leukodystrophy (MLD) is a lysosomal storage disease which is commonly listed in the family of leukodystrophies as well as among the sphingolipidoses as it affects the metabolism of sphingolipids. Leukodystrophies affect the growth and/or development of myelin, the fatty covering which acts as an insulator around nerve fibers throughout the central and peripheral nervous systems. MLD involves cerebroside sulfate accumulation. Metachromatic leukodystrophy, like most enzyme deficiencies, has an autosomal recessive inheritance pattern.

<span class="mw-page-title-main">Cell therapy</span> Therapy in which cellular material is injected into a patient

Cell therapy is a therapy in which viable cells are injected, grafted or implanted into a patient in order to effectuate a medicinal effect, for example, by transplanting T-cells capable of fighting cancer cells via cell-mediated immunity in the course of immunotherapy, or grafting stem cells to regenerate diseased tissues.

Cord blood is blood that remains in the placenta and in the attached umbilical cord after childbirth. Cord blood is collected because it contains stem cells, which can be used to treat hematopoietic and genetic disorders such as cancer. There is growing interest from cell therapeutics companies in developing genetically modified allogenic natural killer cells from umbilical cord blood as an alternative to CAR T cell therapies for rare diseases.

Total body irradiation (TBI) is a form of radiotherapy used primarily as part of the preparative regimen for haematopoietic stem cell transplantation. As the name implies, TBI involves irradiation of the entire body, though in modern practice the lungs are often partially shielded to lower the risk of radiation-induced lung injury. Total body irradiation in the setting of bone marrow transplantation serves to destroy or suppress the recipient's immune system, preventing immunologic rejection of transplanted donor bone marrow or blood stem cells. Additionally, high doses of total body irradiation can eradicate residual cancer cells in the transplant recipient, increasing the likelihood that the transplant will be successful.

Stem-cell therapy is the use of stem cells to treat or prevent a disease or condition. As of 2016, the only established therapy using stem cells is hematopoietic stem cell transplantation. This usually takes the form of a bone-marrow transplantation, but the cells can also be derived from umbilical cord blood. Research is underway to develop various sources for stem cells as well as to apply stem-cell treatments for neurodegenerative diseases and conditions such as diabetes and heart disease.

The National Marrow Donor Program (NMDP) is a nonprofit organization founded in 1986 and based in Minneapolis, Minnesota, that operates the Be The Match Registry of volunteer hematopoietic cell donors and umbilical cord blood units in the United States.

<span class="mw-page-title-main">CXCL2</span> Mammalian protein found in Homo sapiens

Chemokine ligand 2 (CXCL2) is a small cytokine belonging to the CXC chemokine family that is also called macrophage inflammatory protein 2-alpha (MIP2-alpha), Growth-regulated protein beta (Gro-beta) and Gro oncogene-2 (Gro-2). CXCL2 is 90% identical in amino acid sequence as a related chemokine, CXCL1. This chemokine is secreted by monocytes and macrophages and is chemotactic for polymorphonuclear leukocytes and hematopoietic stem cells. The gene for CXCL2 is located on human chromosome 4 in a cluster of other CXC chemokines. CXCL2 mobilizes cells by interacting with a cell surface chemokine receptor called CXCR2.

<span class="mw-page-title-main">Plerixafor</span>

Plerixafor is an immunostimulant used to mobilize hematopoietic stem cells in cancer patients into the bloodstream. The stem cells are then extracted from the blood and transplanted back to the patient. The drug was developed by AnorMED, which was subsequently bought by Genzyme.

<span class="mw-page-title-main">Peripheral stem cell transplantation</span>

Peripheral blood stem cell transplantation (PBSCT), also called "Peripheral stem cell support", is a method of replacing blood-forming stem cells. Stem cells can be destroyed through cancer treatments such as chemotherapy or radiation, as well as any blood-related diseases, such as leukemia, lymphoma, neuroblastoma and multiple myeloma. PBSCT is now a much more common procedure than its bone marrow harvest equivalent due to the ease and less invasive nature of the procedure. Studies suggest that PBSCT has a better outcome in terms of the number of hematopoietic stem cell yield.

<span class="mw-page-title-main">Reticular dysgenesis</span> Medical condition

Reticular dysgenesis (RD) is a rare, inherited autosomal recessive disease that results in immunodeficiency. Individuals with RD have mutations in both copies of the AK2 gene. Mutations in this gene lead to absence of AK2 protein. AK2 protein allows hematopoietic stem cells to differentiate and proliferate. Hematopoietic stem cells give rise to blood cells.

High-dose chemotherapy and bone marrow transplant (HDC/BMT), also high-dose chemotherapy with autologous bone marrow transplant, was an ineffective treatment regimen for metastatic breast cancer, and later high-risk breast cancer, that was considered promising during the 1980s and 1990s. With an overall idea that more is better, this process involved taking cells from the person's bone marrow to store in a lab, then to give such high doses of chemotherapy drugs that the remaining bone marrow was destroyed, and then to inject the cells taken earlier back into the body as replacement. It was ultimately determined to be no more effective than normal treatment, and to have significantly higher side effects, including treatment-related death.

Guo Mei is a hematologist and associate director of 307th Hospital of Chinese People’s Liberation Army and deputy director of Radiation Research Institute.

<span class="mw-page-title-main">Shimon Slavin</span> Israeli professor of medicine

Shimon Slavin, M.D., is an Israeli professor of medicine. Slavin pioneered the use of immunotherapy mediated by allogeneic donor lymphocytes and innovative methods for stem cell transplantation for the cure of hematological malignancies and solid tumors, and using hematopoietic stem cells for induction of transplantation tolerance to bone marrow and donor allografts.

OTL-103 (GSK-2696275) is a gene therapy for Wiskott–Aldrich syndrome, a rare primary immunodeficiency caused by mutations in the gene that codes for Wiskott–Aldrich syndrome protein (WASp). It was developed by Orchard Therapeutics in conjunction with GlaxoSmithKline. It is currently undergoing Phase I/II of clinical trials that are expected to conclude in October 2025.

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. 1 2 "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. ↑ "Genesis Prize and Start-up Nation Central announce winners of the competition in honor of Natan Sharansky". Genesis Prize Foundation. 24 December 2020.
  9. ↑ "Pluristem Therapeutics renames as Pluri". Seeking Alpha. July 25, 2022.
  10. ↑ 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.
  11. ↑ 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.
  12. 1 2 "Pluristem's Pivotal Phase III Critical Limb Ischemia Trial Approved by UK Regulatory Agency | AMP Central". Archived from the original on 2018-11-06. Retrieved 2017-05-17.
  13. ↑ "Pluristem Therapeutics (PSTI) Updates on PLX-R18 Development Strategy".
  14. ↑ 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.
  15. ↑ 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. Bibcode:2013PLoSO...866549G. doi: 10.1371/journal.pone.0066549 . ISSN   1932-6203. PMC   3688917 . PMID   23823334.
  16. ↑ Gabison, Yoram (2011-04-12). "Pluristem, Hadassah to Work on Stem Cell Cure for Radiation Damage". Haaretz. Retrieved 2017-08-28.
  17. ↑ "Pluristem, NIH to study stem cells to treat radiation syndrome". Reuters. 26 July 2012 – via www.reuters.com.
  18. ↑ "Pluristem's post nuclear exposure study in primates a success". Drug Target Review.
  19. ↑ Dey, Esha (9 May 2012). "Pluristem stem cell therapy saves a patient, shares jump". The Baltimore Sun . Reuters . Retrieved 9 May 2012.[ permanent dead link ]
  20. ↑ "Pluristem stem cells save girl's life". Globes . 9 May 2012. Retrieved 9 May 2012.
  21. ↑ 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.
  22. ↑ 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.
  23. ↑ 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.'
  24. ↑ Goldman, Dudi (12 May 2012). "Israeli innovation saves Romanian girl's life". Ynetnews . Retrieved 26 May 2012.
  25. ↑ "Pluristem stem cells save 3rd bone marrow disease patient". Globes . 5 September 2012. Retrieved 10 September 2012.
  26. ↑ Press, Viva Sarah (21 January 2016). "FDA greenlights clinical trial for new Israeli cell therapy". Israel21c.
  27. ↑ "Israeli firm hopeful as it starts treating COVID-19 patients with placenta cells". The Times of Israel .
  28. ↑ "Pluristem's IND Application for Phase II Study of PLX Cells for COVID-19 Treatment Receives FDA Clearance". 11 May 2020.
  29. ↑ "FDA Covid-19 trial nod boosts Pluristem". Globes. 5 October 2020.
  30. ↑ "Pluristem renews German collaboration". Globes . 21 August 2012.
  31. ↑ "Pluristem wins NIS 9m Chief Scientist grant". Globes . 18 January 2012. Retrieved 9 May 2012.
  32. ↑ Solomon, Shoshanna (30 April 2012). "Pluristem Heads for Two-Month High on $3.2 Million Israeli Grant". Bloomberg . Retrieved 9 May 2012.
  33. ↑ "Stem cell co Pluristem awarded $3.1m chief scientist grant". Globes . 1 May 2012. Retrieved 9 May 2012.
  34. ↑ "Pluristem Attracts in $8 Millon in Funding for Phase III Critical Limb Ischemia (CLI) Study". BioInformant. 9 August 2016.
  35. ↑ "Pluristem Therapeutics says $7.9 mln non-dilutive grant from European Union's horizon 2020 program has been awarded to nTRACK". Reuters. October 2, 2017.
  36. ↑ "Stem cell co Pluristem awarded $8.7m EU grant". Globes. 6 September 2017.
  37. ↑ Ringler, Elana (9 March 2016). "Israeli placental cell therapy could cure radiation sickness". Reuters– via www.reuters.com.
  38. ↑ "Pluristem joins CRISPR-IL to develop next-gen genome editing products". The Jerusalem Post. 4 June 2020.
  39. 1 2 "Israel's biggest food maker enters JV to put 'affordable cultured food on the table'". FoodNavigator. January 18, 2022.
  40. ↑ "Israel's Tnuva partners with Pluristem to develop cultured cell-based meat". The Jerusalem Post. 2 September 2022.
  41. ↑ "Pluristem and Tnuva Ring the Closing Bell". Nasdaq. March 28, 2022.
This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.