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International Alliance of ALS/MND Associations

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Collaborative Medicinal Development – CuATSM

Collaborative Medicinal Development – CuATSM

Background

An Australian company called Collaborative Medicinal Development, LLC are clinically developing a compound called CuATSM. In 2018 results were released from a phase 1 clinical trial that was designed determine only if CuATSM is safe for humans and to determine what dose (if safe) would be ideal to test in a further clinical trial (phase 2 or 3). Later trials would be designed to further examine safety and to eventually determine if it has the ability to alter ALS disease progression. Specific aspects of the phase 1 trial make it not ideal for interpretation of CuATSM effect on disease progression.

On January 7th 2019, television spots and a media release stated that CuATSM slowed disease progression by 70% in the phase 1 clinical trial participants. This resulted in an international outcry for people living with ALS to access CuATSM, with particularly strong interest in Australia and the UK. Online petitions yielded a need for response and questions have arisen in multiple Alliance organization countries. A need for a balanced and scientifically accurate response that does not ruin the optimism around CuATSM’s potential is needed.

In late 2019, a phase 2/3 clinical trial of 80 people started recruiting in Australia (NCT04082832). It is setup to give a better indication of a treatment effect than the phase 1 trial, though the sample size would require a very large slowing of disease progression to be significant.

Recommendation

The SAC recommends that Alliance members refer to CuATSM as a drug that has shown potential to treat ALS in laboratory animal models and 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 in humans. Furthermore, until there is a peer-reviewed publication of the data, it is not possible at this time to evaluate the safety beyond the claims of the release.

 The ongoing phase 2/3 clinical trial will futher assess safety at the chosen dose and is designed to get a better indication of a potential to positively affect ALS disease course. The trial size is small and caution may again need to be taken when interpreting the results. The field remains hopeful that CuATSM will work, but the proper trials need to be done before anything can be known.

 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
June 2020

 


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

Primary Sidebar

Drugs in Clinical Trial

  • Amylyx – AMX0035
  • Biogen – Tofersen
  • BrainStorm Cell Therapeutics – NurOwn
  • Clene Nanomedicine – CNM-Au8
  • Collaborative Medicinal Development – CuATSM
  • Cytokinetics – Reldesemtiv
  • Kadimastem – AstroRx
  • Mitsubishi Tanabe Pharma America – Oral Edaravone
  • Orphazyme – Arimoclomol
  • T Regulatory Cell Therapies

  • Irene McCaughey, Diagnosed 2011 - MND Australia

    Irene McCaughey, Diagnosed 2011 – MND Australia

  • Lachlan Terry, MND Australia, Diagnosed 2015, Australia

    Lachlan Terry, MND Australia, Diagnosed 2015, Australia

  • Charlie “Hark” Dourney, Diagnosed 2007 - Hark ALS, USA

    Charlie “Hark” Dourney, Diagnosed 2007 – Hark ALS, USA

  • Zabun Nassar, MND Association, Diagnosed 2016, England

    Zabun Nassar, MND Association, Diagnosed 2016, England

  • Duncan Bayly - MND Australia

    Duncan Bayly – MND Australia

  • Philip Brindle, MND Association, Diagnosed 2015, England

    Philip Brindle, MND Association, Diagnosed 2015, England

  • Jon Newsome, Les Turner ALS Foundation, USA

    Jon Newsome, Les Turner ALS Foundation, USA

  • Joanne Pratt, Diagnosed 2011 - MND Australia

    Joanne Pratt, Diagnosed 2011 – MND Australia

  • Mark-Miller

    Mark-Miller

  • David-Bishop-copy-2

    David-Bishop-copy-2

  • Valdomiro-Xavier-Honorio-ABrELA

    Valdomiro-Xavier-Honorio-ABrELA

  • Shay Rishoni, Diagnosed 2011 - Prize4Life, Israel

    Shay Rishoni, Diagnosed 2011 – Prize4Life, Israel

  • Wilfried Leusing, Diagnosed 2010 - DGM, Germany

    Wilfried Leusing, Diagnosed 2010 – DGM, Germany

  • pALS-Guido-De-Mets-ALS-Liga-Belgium

    pALS-Guido-De-Mets-ALS-Liga-Belgium

  • Fabio-Carvalho3

    Fabio-Carvalho3

  • 55405686-609D-4060-BB1E-8697F36FA62F

    55405686-609D-4060-BB1E-8697F36FA62F

  • Ann-Nicol

    Ann-Nicol

  • Roxana Canova, Diagnosed 2012 - Asociación ELA Argentina

    Roxana Canova, Diagnosed 2012 – Asociación ELA Argentina

  • Ian Roberts

    Ian Roberts

  • Francisco Perez Palop, Diagnosed 2013 - FUNDELA, Spain

    Francisco Perez Palop, Diagnosed 2013 – FUNDELA, Spain

  • Oliver Juenke, DGM, Germany

    Oliver Juenke, DGM, Germany

  • Zelina-Brito-Diagnosed-2018-Brazil

    Zelina-Brito-Diagnosed-2018-Brazil

  • Brian Lovell, Diagnosed 2011 - MND Australia

    Brian Lovell, Diagnosed 2011 – MND Australia

  • Karl Hughes, Diagnosed 2010 - IMNDA, Ireland

    Karl Hughes, Diagnosed 2010 – IMNDA, Ireland

  • Marcel R. Wernard, Diagnosed 2016 - ALS Patients Connected, The Netherlands

    Marcel R. Wernard, Diagnosed 2016 – ALS Patients Connected, The Netherlands

  • 20200117_214643

    20200117_214643

  • Chris McCauley, Diagnosed 2015 - ALS Canada

    Chris McCauley, Diagnosed 2015 – ALS Canada

  • final3878

    final3878

  • Norm MacIsaac, ALS Society of Canada, ALS Society of Quebec, Diagnosed 2014, Canada

    Norm MacIsaac, ALS Society of Canada, ALS Society of Quebec, Diagnosed 2014, Canada

  • MND-Robbie-Caliste

    MND-Robbie-Caliste

  • IMG_3993

    IMG_3993

  • Dorette Lüdi, Diagnosed 2014 - ALS Schweiz, Switzerland

    Dorette Lüdi, Diagnosed 2014 – ALS Schweiz, Switzerland

  • Joyce Rusinak, Forbes Norris ALS Center, USA

    Joyce Rusinak, Forbes Norris ALS Center, USA

  • Antonio Ventriglia, ALS Liga Belgium, Diagnosed 2013, Belgium

    Antonio Ventriglia, ALS Liga Belgium, Diagnosed 2013, Belgium

  • Joy Blakeley, Diagnosed 2017 - MND Australia

    Joy Blakeley, Diagnosed 2017 – MND Australia

  • Soledad Rodriguez, FUNDELA, Diagnosed 2013, Spain

    Soledad Rodriguez, FUNDELA, Diagnosed 2013, Spain

  • Inta Grubb, Diagnosed 2014 - MND Australia

    Inta Grubb, Diagnosed 2014 – MND Australia

  • Alejandro Aquino, Diagnosed 2011 - Asociación ELA Argentina

    Alejandro Aquino, Diagnosed 2011 – Asociación ELA Argentina

  • Liong Ting Ngu, MND Malaysia, Diagnosed 2014, Malaysia

    Liong Ting Ngu, MND Malaysia, Diagnosed 2014, Malaysia

  • Margreth Burger-Saile, Diagnosed 2011 - ALS Schweiz, Switzerland

    Margreth Burger-Saile, Diagnosed 2011 – ALS Schweiz, Switzerland

  • Ailsa Malcolm-Hutton, Diagnosed 2013 - MND Association of England, Wales and N Ireland

    Ailsa Malcolm-Hutton, Diagnosed 2013 – MND Association of England, Wales and N Ireland

  • Fabio-Correia-2

    Fabio-Correia-2

  • Frank "Papa" Taylor

    Frank “Papa” Taylor

  • Glen Elison, ALS Hope Foundation, Diagnosed 2019, USA

    Glen Elison, ALS Hope Foundation, Diagnosed 2019, USA

  • Maurice LeClerc, ALS Canada

    Maurice LeClerc, ALS Canada

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

    Danny Reviers, Diagnosed 1979 – ALS Liga België, Belgium

  • Willi-Klein

    Willi-Klein

  • roy

    roy

  • Sally Pauls, Diagnosed 2006 - Les Turner ALS Foundation

    Sally Pauls, Diagnosed 2006 – Les Turner ALS Foundation

  • ALS-0571

    ALS-0571

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