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Mesoblast

January 01, 1970

Mesoblast Limited is an Australian regenerative medicine company. It seeks to provide treatments for inflammatory ailments, cardiovascular disease, and back pain. The company is led by Silviu Itescu, who founded the company in 2004.[1]

History edit

In Mesoblast's annual report from August 2010, the company first announced positive results of preclinical trials showing radiographic and pathologic disc regeneration with MPC-06-ID. Mesoblast said they were in the process of completing an Investigational New Drug (IND) submission to the United States FDA to commence Phase 2 clinical trials.[2] In December 2010, Mesoblast entered into an agreement with US-based Cephalon to develop and commercialize novel adult Mesenchymal Precursor Stem Cell (MPC) therapeutics for degenerative conditions of the cardiovascular and central nervous systems.[3]

In September 2011, Mesoblast entered into an agreement with Swiss-based Lonza Group. Under the agreement, Lonza will manufacture the stem cells for Mesoblast's MPC cell products. Mesoblast will also have exclusive access to Lonza's Cell Therapy facilities in Singapore for the manufacture of allogeneic cell therapy.[4]

Osiris sold its MSC drug and patents to Mesoblast Ltd. in 2012.[5] In March 2014, Circulation Journal published the results of a clinical trial using MPCs as adjunctive therapy for patients with a Ventricular Assist Device.[6] In May 2014, Mesoblast announced it would receive incentives from the Singapore Economic Development Board (EDB) for activities in Singapore related to manufacturing operations, product development, and commercialization.[7]

On February 10, 2015, Mesoblast was granted a patent by the United States Patent and Trademark Office (USPTO) covering its proprietary Mesenchymal Precursor Cell (MPC) technology for use in the treatment of degenerated intervertebral discs.[8] In June 2015, Mesoblast received $5.8 million from the Australian Government for Research and Development (R&D) activities conducted during the 2014 financial year. The funds were provided to Mesoblast under the Government's R&D Tax Incentive Program.[9]

In February 2016, Mesoblast's Licensee (JCR Pharmaceuticals Co., Ltd.) sold its first allogeneic cell product for the treatment of acute graft versus host disease (aGVHD) in children and adults in Japan. TEMCELL is the first allogeneic cell therapy to be fully approved in Japan.[10] In December 2016, Mesoblast and Mallinckrodt Pharmaceuticals entered into an agreement to exclusively negotiate a commercial and development partnership for MPC-06-ID in the treatment of chronic low back pain due to disc degeneration.[11]

Research edit

Mesenchymal lineage cells edit

Mesoblast products are largely derived from its proprietary mesenchymal lineage cells.[12] This includes Mesenchymal Precursor Cells (MPCs) and Mesenchymal Stem Cells (MSCs).

Focus areas edit

  • Back pain: Mesoblast's investigational product candidate MPC-06-ID is being developed.[8]
  • Rheumatoid Arthritis: On 24 March 2016 US patent 9,265,796 was granted for the use of Mesenchymal Precursor Cells (MPCs)for the treatment or prevention of rheumatic conditions, including rheumatoid arthritis, osteoarthritis, psoriatic arthritis, ankylosing spondylitis, sacroiliitis, enteric arthritis, and reactive arthritis.[13][14]
  • Crohn's disease: A trial was announced to evaluate Prochymal in moderate to severe Crohn's Disease.[15]
  • Diabetic nephropathy: Mesoblast presented the results of a trial involving product candidate MPC-300-IV at the late-breaking scientific sessions of the 75th annual meeting of the American Diabetes Association.[16]
  • COVID-19 Acute Respiratory Distress Symptoms: In 2020, Ryoncil was tested on late-stage, ventilator-assisted COVID-19 patients with Acute Respiratory Distress Syndrome in the United States.[17][18]

Criticism edit

Mesoblast's solution for back pain came under heavy criticism from competitor Regenexx in August 2015. Dr. Chris Centeno said the trial results were "spit shined" with confusing and misleading language, press releases for phases 1 and 2 did not include images of MRIs to prove that discs were regenerated and expressed doubts about maintaining cell quality while mass-producing cells. He also said the host's immune system removes the injected stem cells.[19]

Financial performance edit

Mesoblast is listed as MSB on the Australian Securities Exchange (ASX), as MESO on the NASDAQ, and as MEOBF on the ATC Markets.

The company reported its financial results in November 2020.[20] As of September 30, 2020:

  • Cash on hand was $108.1 million
  • Net loss before tax $25.3 million
  • Cash outflows for Q1 FY21 were $24.5 million.

References edit

  1. ^ "BRW Rich 200 list 2014: 136. Silviu Itescu". BRW. Retrieved 13 June 2015. [dead link]
  2. ^ Mesoblast document [dead link]
  3. ^ "Cephalon and Mesoblast Enter Into Strategic Alliance to Develop... -- FRAZER, Pa. and MELBOURNE, Australia, Dec. 7, 2010 /PRNewswire-FirstCall/ --" (Press release). Mesoblast Limited. 7 December 2010.
  4. ^ "Mesoblast and Lonza partner to mass-produce stem cells". www.labonline.com.au. Retrieved 28 March 2024.
  5. ^ Waltz, Emily (1 December 2013). "Mesoblast acquires Osiris' stem cell business". Nature Biotechnology. 31 (12): 1061. doi:10.1038/nbt1213-1061. ISSN 1546-1696. S2CID 32036070.
  6. ^ Ascheim, D.D. (2014). "Mesenchymal Precursor Cells as Adjunctive Therapy in Recipients of Contemporary LVADs". Circulation. 129 (22): 1–52. doi:10.1161/CIRCULATIONAHA.113.007412. PMC 4243683. PMID 24682346.
  7. ^ Mesoblast (28 May 2014). "Mesoblast Accelerates Plans For Commercialization Manufacturing Operations In Singapore". GlobeNewswire News Room (Press release).
  8. ^ a b "News Announcements". Mesoblast. [dead link]
  9. ^ Report mesoblast.com [dead link]
  10. ^ Mesoblast document [dead link]
  11. ^ "ASX Announcements | Mesoblast". Retrieved 28 March 2024. [dead link]
  12. ^ . Archived from the original on 17 January 2015. Retrieved 7 November 2014.
  13. ^ ASX. "KEY UNITED STATES PATENT GRANTED FOR CELL-BASED TREATMENT OF RHEUMATOID ARTHRITIS AND OTHER RHEUMATIC CONDITIONS" (PDF). Retrieved 24 March 2016.
  14. ^ US Patent 9265796, Peter Ghosh & Silviu Itescu, "Methods of treating or preventing rheumatic disease", published 2014-09-18, assigned to MESOBLAST, INC. 
  15. ^ Mesoblast. "Crohn's Disease". Mesoblast. [dead link]
  16. ^ Report mesoblast.com [dead link]
  17. ^ Sheikh, Knvul; Thomas, Katie (8 May 2020). "More Coronavirus Vaccines and Treatments Move Toward Human Trials". The New York Times. ISSN 0362-4331. Retrieved 13 August 2020.
  18. ^ Knapp, Alex (2 May 2020). "Clinical Trials Of Mesoblast's Stem Cell Treatment For COVID-19 Set To Begin Soon". Forbes. Retrieved 13 August 2020.
  19. ^ "Did the Mesoblast Stem Cell Disc Trial Succeed or Fail? -Regenexx®". 5 August 2015.
  20. ^ Financial Results for First Quarter Ended September 30, 2020 mesoblast.com

January 01, 1970
mesoblast, this, article, multiple, issues, please, help, improve, discuss, these, issues, talk, page, learn, when, remove, these, template, messages, this, article, contains, content, that, written, like, advertisement, please, help, improve, removing, promot. This article has multiple issues Please help improve it or discuss these issues on the talk page Learn how and when to remove these template messages This article contains content that is written like an advertisement Please help improve it by removing promotional content and inappropriate external links and by adding encyclopedic content written from a neutral point of view April 2020 Learn how and when to remove this message The topic of this article may not meet Wikipedia s general notability guideline Please help to demonstrate the notability of the topic by citing reliable secondary sources that are independent of the topic and provide significant coverage of it beyond a mere trivial mention If notability cannot be shown the article is likely to be merged redirected or deleted Find sources Mesoblast news newspapers books scholar JSTOR April 2023 Learn how and when to remove this message This article possibly contains original research Please improve it by verifying the claims made and adding inline citations Statements consisting only of original research should be removed April 2023 Learn how and when to remove this message This article may contain excessive or inappropriate references to self published sources Please help improve it by removing references to unreliable sources where they are used inappropriately April 2023 Learn how and when to remove this message Learn how and when to remove this message Mesoblast Limited is an Australian regenerative medicine company It seeks to provide treatments for inflammatory ailments cardiovascular disease and back pain The company is led by Silviu Itescu who founded the company in 2004 1 Contents 1 History 2 Research 2 1 Mesenchymal lineage cells 2 2 Focus areas 3 Criticism 4 Financial performance 5 ReferencesHistory editIn Mesoblast s annual report from August 2010 the company first announced positive results of preclinical trials showing radiographic and pathologic disc regeneration with MPC 06 ID Mesoblast said they were in the process of completing an Investigational New Drug IND submission to the United States FDA to commence Phase 2 clinical trials 2 In December 2010 Mesoblast entered into an agreement with US based Cephalon to develop and commercialize novel adult Mesenchymal Precursor Stem Cell MPC therapeutics for degenerative conditions of the cardiovascular and central nervous systems 3 In September 2011 Mesoblast entered into an agreement with Swiss based Lonza Group Under the agreement Lonza will manufacture the stem cells for Mesoblast s MPC cell products Mesoblast will also have exclusive access to Lonza s Cell Therapy facilities in Singapore for the manufacture of allogeneic cell therapy 4 Osiris sold its MSC drug and patents to Mesoblast Ltd in 2012 5 In March 2014 Circulation Journal published the results of a clinical trial using MPCs as adjunctive therapy for patients with a Ventricular Assist Device 6 In May 2014 Mesoblast announced it would receive incentives from the Singapore Economic Development Board EDB for activities in Singapore related to manufacturing operations product development and commercialization 7 On February 10 2015 Mesoblast was granted a patent by the United States Patent and Trademark Office USPTO covering its proprietary Mesenchymal Precursor Cell MPC technology for use in the treatment of degenerated intervertebral discs 8 In June 2015 Mesoblast received 5 8 million from the Australian Government for Research and Development R amp D activities conducted during the 2014 financial year The funds were provided to Mesoblast under the Government s R amp D Tax Incentive Program 9 In February 2016 Mesoblast s Licensee JCR Pharmaceuticals Co Ltd sold its first allogeneic cell product for the treatment of acute graft versus host disease aGVHD in children and adults in Japan TEMCELL is the first allogeneic cell therapy to be fully approved in Japan 10 In December 2016 Mesoblast and Mallinckrodt Pharmaceuticals entered into an agreement to exclusively negotiate a commercial and development partnership for MPC 06 ID in the treatment of chronic low back pain due to disc degeneration 11 Research editMesenchymal lineage cells edit Mesoblast products are largely derived from its proprietary mesenchymal lineage cells 12 This includes Mesenchymal Precursor Cells MPCs and Mesenchymal Stem Cells MSCs Focus areas edit Back pain Mesoblast s investigational product candidate MPC 06 ID is being developed 8 Rheumatoid Arthritis On 24 March 2016 US patent 9 265 796 was granted for the use of Mesenchymal Precursor Cells MPCs for the treatment or prevention of rheumatic conditions including rheumatoid arthritis osteoarthritis psoriatic arthritis ankylosing spondylitis sacroiliitis enteric arthritis and reactive arthritis 13 14 Crohn s disease A trial was announced to evaluate Prochymal in moderate to severe Crohn s Disease 15 Diabetic nephropathy Mesoblast presented the results of a trial involving product candidate MPC 300 IV at the late breaking scientific sessions of the 75th annual meeting of the American Diabetes Association 16 COVID 19 Acute Respiratory Distress Symptoms In 2020 Ryoncil was tested on late stage ventilator assisted COVID 19 patients with Acute Respiratory Distress Syndrome in the United States 17 18 Criticism editMesoblast s solution for back pain came under heavy criticism from competitor Regenexx in August 2015 Dr Chris Centeno said the trial results were spit shined with confusing and misleading language press releases for phases 1 and 2 did not include images of MRIs to prove that discs were regenerated and expressed doubts about maintaining cell quality while mass producing cells He also said the host s immune system removes the injected stem cells 19 Financial performance editThis section needs to be updated Please help update this article to reflect recent events or newly available information November 2020 Mesoblast is listed as MSB on the Australian Securities Exchange ASX as MESO on the NASDAQ and as MEOBF on the ATC Markets The company reported its financial results in November 2020 20 As of September 30 2020 Cash on hand was 108 1 million Net loss before tax 25 3 million Cash outflows for Q1 FY21 were 24 5 million References edit BRW Rich 200 list 2014 136 Silviu Itescu BRW Retrieved 13 June 2015 dead link Mesoblast document dead link Cephalon and Mesoblast Enter Into Strategic Alliance to Develop FRAZER Pa and MELBOURNE Australia Dec 7 2010 PRNewswire FirstCall Press release Mesoblast Limited 7 December 2010 Mesoblast and Lonza partner to mass produce stem cells www labonline com au Retrieved 28 March 2024 Waltz Emily 1 December 2013 Mesoblast acquires Osiris stem cell business Nature Biotechnology 31 12 1061 doi 10 1038 nbt1213 1061 ISSN 1546 1696 S2CID 32036070 Ascheim D D 2014 Mesenchymal Precursor Cells as Adjunctive Therapy in Recipients of Contemporary LVADs Circulation 129 22 1 52 doi 10 1161 CIRCULATIONAHA 113 007412 PMC 4243683 PMID 24682346 Mesoblast 28 May 2014 Mesoblast Accelerates Plans For Commercialization Manufacturing Operations In Singapore GlobeNewswire News Room Press release a b News Announcements Mesoblast dead link Report mesoblast com dead link Mesoblast document dead link ASX Announcements Mesoblast Retrieved 28 March 2024 dead link Ondek Mesoblast and Sirtex investors roll the biotech dice the Australian Archived from the original on 17 January 2015 Retrieved 7 November 2014 ASX KEY UNITED STATES PATENT GRANTED FOR CELL BASED TREATMENT OF RHEUMATOID ARTHRITIS AND OTHER RHEUMATIC CONDITIONS PDF Retrieved 24 March 2016 US Patent 9265796 Peter Ghosh amp Silviu Itescu Methods of treating or preventing rheumatic disease published 2014 09 18 assigned to MESOBLAST INC Mesoblast Crohn s Disease Mesoblast dead link Report mesoblast com dead link Sheikh Knvul Thomas Katie 8 May 2020 More Coronavirus Vaccines and Treatments Move Toward Human Trials The New York Times ISSN 0362 4331 Retrieved 13 August 2020 Knapp Alex 2 May 2020 Clinical Trials Of Mesoblast s Stem Cell Treatment For COVID 19 Set To Begin Soon Forbes Retrieved 13 August 2020 Did the Mesoblast Stem Cell Disc Trial Succeed or Fail Regenexx 5 August 2015 Financial Results for First Quarter Ended September 30 2020 mesoblast com Retrieved from https en wikipedia org w index php title Mesoblast amp oldid 1218706257, wikipedia, wiki, book, books, library,

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