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International Alliance of ALS/MND Associations

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Collaborative Medicinal Development – CuATSM

Background

An Australian company called Collaborative Medicinal Development; LLC are clinically testing a compound called CuATSM. In 2018, results were released from a phase 1 clinical trial that was designed only to determine the safety and dosing of CuATSM. Later trials (phase 2 or 3) would be designed to further examine safety and to eventually determine if it has the ability to alter ALS/MND disease progression.

On January 7th, 2019, television spots and a media release stated that CuATSM slowed disease progression in the phase 1 clinical trial participants. This resulted in an international outcry for people living with ALS/MND to access CuATSM. Further studies were required to provide a clear indication of whether these preliminary results were reliable.

Trial Design & Results

In late 2019, a Phase 2/3 clinical trial of 80 people started recruiting in Australia (NCT04082832). It was setup to provide stronger evidence for a treatment effect than the phase 1 trial. The size of this Phase 2/3 trial meant however, that a very large slowing of disease progression would be required for a statistically significant effect to be seen.

The Phase 2/3 trial was completed in late 2021 although the outcome of the trial has yet to be announced. It is very disappointing that Collaborative Medicinal Development, LLC have not released the results.

Summary

The SAC recommends that Alliance members refer to CuATSM as a drug that was recently studied for human safety in a small phase 1 clinical trial by the company Collaborative Medicinal Development, LLC in Australia. At the doses tested, using clinical grade CuATSM, it was considered safe, but a press release also states that the company has seen a substantial slowing of disease progression. This clinical trial was not designed to make such a public statement and a number of aspects in its design require this result to be taken with as much caution as possible. Essentially, there is no substantiated scientific evidence that CuATSM has any advantageous effect on ALS/MND in humans. To date, the follow-on trial results have not been published despite the trial completing in 2021. The SAC urges Collaborative Medicinal Development, LLC to report the outcomes of the trial as soon as possible to the community that has supported this trial.

Please refer to the MND Association blog for a more detailed explanation: https://mndresearch.blog/2019/01/15/whats-the-story-with-cuatsm/

International Alliance of ALS/MND Associations
May 2023


The original language of communication is English and any translation cannot be guaranteed for accuracy of messaging.

Primary Sidebar

Drugs in Development

  • AB Science – Masitinib
  • BrainStorm Cell Therapeutics – NurOwn
  • Clene Nanomedicine – CNM-Au8
  • Collaborative Medicinal Development – CuATSM
  • ILB – Tikomed
  • Kadimastem – AstroRx
  • Methylcobalamin
  • Mitsubishi Tanabe Pharma America – Oral Edaravone
  • Neuronata-R/Lenzumestrocel
  • NeuroSense – PrimeC
  • Neuvivo – NP001
  • T Regulatory Cell Therapies
  • Prilenia Therapeutics – Pridopidine
  • SOD1 Therapies & Trials

  • 727747090571358167

    727747090571358167

  • Elisabeth Zahnd, Switzerland

    Elisabeth Zahnd, Switzerland

  • Tammy Moore and Eddy Lefrancois

    Tammy Moore and Eddy Lefrancois

  • Christian Bär, Germany

    Christian Bär, Germany

  • Brian Parsons

    Brian Parsons

  • Feng Gin Sun, Diagnosed 2014 , Shaanxi ALS Association, China

    Feng Gin Sun, Diagnosed 2014 , Shaanxi ALS Association, China

  • Calum Ferguson, Diagnosed 2010 , MND Scotland, UK

    Calum Ferguson, Diagnosed 2010 , MND Scotland, UK

  • 83

    83

  • Verónica Isabel Castro Molina, Diagnosed 2014, Argentina

    Verónica Isabel Castro Molina, Diagnosed 2014, Argentina

  • Sharon Corosanite, Diagnosed 2014 , ALS Hope Foundation, USA

    Sharon Corosanite, Diagnosed 2014 , ALS Hope Foundation, USA

  • Dick Dayton, USA

    Dick Dayton, USA

  • Dad

    Dad

  • Jan Zuring, Diagnosed 2010 , The Netherlands

    Jan Zuring, Diagnosed 2010 , The Netherlands

  • Willi Klein

    Willi Klein

  • Frank "Papa" Taylor, USA

    Frank “Papa” Taylor, USA

  • Alan Liz Ogg 29042016 000799 lo res

    Alan Liz Ogg 29042016 000799 lo res

  • Danny Reviers, Diagnosed 1979 , ALS Liga België, Belgium

    Danny Reviers, Diagnosed 1979 , ALS Liga België, Belgium

  • Timmy, ALS Liga

    Timmy, ALS Liga

  • Andrietta

    Andrietta

  • Colm Francis Davis, Ireland

    Colm Francis Davis, Ireland

  • Debbie Craghill, USA

    Debbie Craghill, USA

  • Robbie Caliste, UK

    Robbie Caliste, UK

  • Hans Dieter Olszewski, Diagnosed 2010 , DGM, Germany

    Hans Dieter Olszewski, Diagnosed 2010 , DGM, Germany

  • Anita Forte, Les Turner ALS Foundation, USA

    Anita Forte, Les Turner ALS Foundation, USA

  • David Watson,  MND Scotland,  Diagnosed 2018

    David Watson, MND Scotland, Diagnosed 2018

  • Peng Yi-Wen

    Peng Yi-Wen

  • Animesh Kumar, Diagnosed 2013 , Asha Ek Hope Foundation, India

    Animesh Kumar, Diagnosed 2013 , Asha Ek Hope Foundation, India

  • Irene McCaughey, Diagnosed 2011,  MND Australia

    Irene McCaughey, Diagnosed 2011, MND Australia

  • Liam Dwyer, England

    Liam Dwyer, England

  • Ana Lilia RodriguezApoyo Integral Gila A.C., Diagnosed 2018, Mexico

    Ana Lilia RodriguezApoyo Integral Gila A.C., Diagnosed 2018, Mexico

  • David Bishop

    David Bishop

  • Jose Espinosa, Argentina

    Jose Espinosa, Argentina

  • Maurice LeClerc, ALS Canada

    Maurice LeClerc, ALS Canada

  • March of Faces Photo Submission_ALEX_ELA ARGENTINA

    March of Faces Photo Submission_ALEX_ELA ARGENTINA

  • Jeff Sutherland

    Jeff Sutherland
    jspic

  • Joyce Rusinak, Forbes Norris ALS Center, USA

    Joyce Rusinak, Forbes Norris ALS Center, USA

  • Claudette Sturk, ALS Society of Canada

    Claudette Sturk, ALS Society of Canada
    Picture2

  • Maria Santos Garcia Tellez, Diagnosed 2017 , FYADENMAC, Mexico

    Maria Santos Garcia Tellez, Diagnosed 2017 , FYADENMAC, Mexico

  • Imelda Arenas, ACELA, Colombia

    Imelda Arenas, ACELA, Colombia

  • Fabrice Kamp, Germany

    Fabrice Kamp, Germany

  • Amparo Muriel Engativa, Colombia

    Amparo Muriel Engativa, Colombia

  • Hollister

    Hollister
    hollister

  • H. Todd Kelly, Diagnosed 2013 , ALS Hope Foundation, USA

    H. Todd Kelly, Diagnosed 2013 , ALS Hope Foundation, USA

  • Lachlan Terry,  MND Australia,  Diagnosed 2015

    Lachlan Terry, MND Australia, Diagnosed 2015

  • Oliver Juenke, Germany

    Oliver Juenke, Germany

  • Lin Yong Yi, Taiwan MND Association, Diagnosed 2004

    Lin Yong Yi, Taiwan MND Association, Diagnosed 2004

  • Wilfried Leusing

    Wilfried Leusing

  • Liz Ogg, Diagnosed 2013 , MND Scotland, UK

    Liz Ogg, Diagnosed 2013 , MND Scotland, UK

  • Dawn Morton, Diagnosed 2014 , MND Scotland, UK

    Dawn Morton, Diagnosed 2014 , MND Scotland, UK

  • Ian Gale, MND Australia

    Ian Gale, MND Australia

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