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June 2015; 2 (3) ArticleOpen Access

Randomized phase 2 trial of NP001, a novel immune regulator

Safety and early efficacy in ALS

Robert G. Miller, Gilbert Block, Jonathan S. Katz, Richard J. Barohn, Vidhya Gopalakrishnan, Merit Cudkowicz, Jane R. Zhang, Michael S. McGrath, Elizabeth Ludington, Stan H. Appel, Ari Azhir
First published April 9, 2015, DOI: https://doi.org/10.1212/NXI.0000000000000100
Robert G. Miller
From the California Pacific Medical Center (R.G.M., J.S.K.), San Francisco, CA; Neuraltus Pharmaceuticals, Inc. (G.B., V.G., M.S.M., A.A.), Palo Alto, CA; University of Kansas (R.J.B.), Kansas City; Massachusetts General Hospital (M.C.), Boston; University of California, San Francisco (R.Z., M.S.M.); Agility Clinical, Inc. (E.L.), Carlsbad, CA; and The Methodist Hospital (S.H.A.), Houston, TX.
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Gilbert Block
From the California Pacific Medical Center (R.G.M., J.S.K.), San Francisco, CA; Neuraltus Pharmaceuticals, Inc. (G.B., V.G., M.S.M., A.A.), Palo Alto, CA; University of Kansas (R.J.B.), Kansas City; Massachusetts General Hospital (M.C.), Boston; University of California, San Francisco (R.Z., M.S.M.); Agility Clinical, Inc. (E.L.), Carlsbad, CA; and The Methodist Hospital (S.H.A.), Houston, TX.
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Jonathan S. Katz
From the California Pacific Medical Center (R.G.M., J.S.K.), San Francisco, CA; Neuraltus Pharmaceuticals, Inc. (G.B., V.G., M.S.M., A.A.), Palo Alto, CA; University of Kansas (R.J.B.), Kansas City; Massachusetts General Hospital (M.C.), Boston; University of California, San Francisco (R.Z., M.S.M.); Agility Clinical, Inc. (E.L.), Carlsbad, CA; and The Methodist Hospital (S.H.A.), Houston, TX.
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Richard J. Barohn
From the California Pacific Medical Center (R.G.M., J.S.K.), San Francisco, CA; Neuraltus Pharmaceuticals, Inc. (G.B., V.G., M.S.M., A.A.), Palo Alto, CA; University of Kansas (R.J.B.), Kansas City; Massachusetts General Hospital (M.C.), Boston; University of California, San Francisco (R.Z., M.S.M.); Agility Clinical, Inc. (E.L.), Carlsbad, CA; and The Methodist Hospital (S.H.A.), Houston, TX.
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Vidhya Gopalakrishnan
From the California Pacific Medical Center (R.G.M., J.S.K.), San Francisco, CA; Neuraltus Pharmaceuticals, Inc. (G.B., V.G., M.S.M., A.A.), Palo Alto, CA; University of Kansas (R.J.B.), Kansas City; Massachusetts General Hospital (M.C.), Boston; University of California, San Francisco (R.Z., M.S.M.); Agility Clinical, Inc. (E.L.), Carlsbad, CA; and The Methodist Hospital (S.H.A.), Houston, TX.
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Merit Cudkowicz
From the California Pacific Medical Center (R.G.M., J.S.K.), San Francisco, CA; Neuraltus Pharmaceuticals, Inc. (G.B., V.G., M.S.M., A.A.), Palo Alto, CA; University of Kansas (R.J.B.), Kansas City; Massachusetts General Hospital (M.C.), Boston; University of California, San Francisco (R.Z., M.S.M.); Agility Clinical, Inc. (E.L.), Carlsbad, CA; and The Methodist Hospital (S.H.A.), Houston, TX.
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Jane R. Zhang
From the California Pacific Medical Center (R.G.M., J.S.K.), San Francisco, CA; Neuraltus Pharmaceuticals, Inc. (G.B., V.G., M.S.M., A.A.), Palo Alto, CA; University of Kansas (R.J.B.), Kansas City; Massachusetts General Hospital (M.C.), Boston; University of California, San Francisco (R.Z., M.S.M.); Agility Clinical, Inc. (E.L.), Carlsbad, CA; and The Methodist Hospital (S.H.A.), Houston, TX.
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Michael S. McGrath
From the California Pacific Medical Center (R.G.M., J.S.K.), San Francisco, CA; Neuraltus Pharmaceuticals, Inc. (G.B., V.G., M.S.M., A.A.), Palo Alto, CA; University of Kansas (R.J.B.), Kansas City; Massachusetts General Hospital (M.C.), Boston; University of California, San Francisco (R.Z., M.S.M.); Agility Clinical, Inc. (E.L.), Carlsbad, CA; and The Methodist Hospital (S.H.A.), Houston, TX.
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Elizabeth Ludington
From the California Pacific Medical Center (R.G.M., J.S.K.), San Francisco, CA; Neuraltus Pharmaceuticals, Inc. (G.B., V.G., M.S.M., A.A.), Palo Alto, CA; University of Kansas (R.J.B.), Kansas City; Massachusetts General Hospital (M.C.), Boston; University of California, San Francisco (R.Z., M.S.M.); Agility Clinical, Inc. (E.L.), Carlsbad, CA; and The Methodist Hospital (S.H.A.), Houston, TX.
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Stan H. Appel
From the California Pacific Medical Center (R.G.M., J.S.K.), San Francisco, CA; Neuraltus Pharmaceuticals, Inc. (G.B., V.G., M.S.M., A.A.), Palo Alto, CA; University of Kansas (R.J.B.), Kansas City; Massachusetts General Hospital (M.C.), Boston; University of California, San Francisco (R.Z., M.S.M.); Agility Clinical, Inc. (E.L.), Carlsbad, CA; and The Methodist Hospital (S.H.A.), Houston, TX.
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Ari Azhir
From the California Pacific Medical Center (R.G.M., J.S.K.), San Francisco, CA; Neuraltus Pharmaceuticals, Inc. (G.B., V.G., M.S.M., A.A.), Palo Alto, CA; University of Kansas (R.J.B.), Kansas City; Massachusetts General Hospital (M.C.), Boston; University of California, San Francisco (R.Z., M.S.M.); Agility Clinical, Inc. (E.L.), Carlsbad, CA; and The Methodist Hospital (S.H.A.), Houston, TX.
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Full PDF
Citation
Randomized phase 2 trial of NP001, a novel immune regulator
Safety and early efficacy in ALS
Robert G. Miller, Gilbert Block, Jonathan S. Katz, Richard J. Barohn, Vidhya Gopalakrishnan, Merit Cudkowicz, Jane R. Zhang, Michael S. McGrath, Elizabeth Ludington, Stan H. Appel, Ari Azhir
Neurol Neuroimmunol Neuroinflamm Jun 2015, 2 (3) e100; DOI: 10.1212/NXI.0000000000000100

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Article Information

vol. 2 no. 3 e100
DOI: 
https://doi.org/10.1212/NXI.0000000000000100
PubMed: 
25884010

Published By: 
Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology
Online ISSN: 
2332-7812
History: 
  • Received September 24, 2014
  • Accepted in final form February 20, 2015
  • First Published April 9, 2015.

Copyright & Usage: 
© 2015 American Academy of Neurology This is an open access article distributed under the terms of the Creative Commons Attribution-Noncommercial No Derivative 3.0 License, which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially.

Author Disclosures

    1. Robert G. Miller, MD,
    2. Gilbert Block, MD, PhD,
    3. Jonathan S. Katz, MD,
    4. Richard J. Barohn, MD,
    5. Vidhya Gopalakrishnan, PhD,
    6. Merit Cudkowicz, MD,
    7. Jane R. Zhang, BS,
    8. Michael S. McGrath, MD, PhD,
    9. Elizabeth Ludington, PhD,
    10. Stan H. Appel, MD and
    11. Ari Azhir, PhD
  1. Robert G. Miller, MD,
  2. Scientific Advisory Boards:
    1. NONE

    Gifts:
    1. NONE

    Funding for Travel or Speaker Honoraria:
    1. NONE

    Editorial Boards:
    1. NONE

    Patents:
    1. NONE

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. NONE

    Consultancies:
    1. NONE

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. NONE

    Research Support, Government Entities:
    1. NONE

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. NONE

    Stock/Stock Options/Board of Directors Compensation:
    1. NONE

    License Fee Payments, Technology or Inventions:
    1. NONE

    Royalty Payments, Technology or Inventions:
    1. NONE

    Stock/Stock Options, Research Sponsor:
    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:
    1. NONE

    Legal Proceedings:
    1. NONE

  3. Gilbert Block, MD, PhD,
  4. Scientific Advisory Boards:
    1. NONE

    Gifts:
    1. NONE

    Funding for Travel or Speaker Honoraria:
    1. NONE

    Editorial Boards:
    1. NONE

    Patents:
    1. NONE

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. NONE

    Consultancies:
    1. NONE

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. NONE

    Research Support, Government Entities:
    1. NONE

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. NONE

    Stock/Stock Options/Board of Directors Compensation:
    1. NONE

    License Fee Payments, Technology or Inventions:
    1. NONE

    Royalty Payments, Technology or Inventions:
    1. NONE

    Stock/Stock Options, Research Sponsor:
    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:
    1. NONE

    Legal Proceedings:
    1. NONE

  5. Jonathan S. Katz, MD,
  6. Scientific Advisory Boards:
    1. NONE

    Gifts:
    1. NONE

    Funding for Travel or Speaker Honoraria:
    1. NONE

    Editorial Boards:
    1. NONE

    Patents:
    1. NONE

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. NONE

    Consultancies:
    1. NONE

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. NONE

    Research Support, Government Entities:
    1. NONE

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. NONE

    Stock/Stock Options/Board of Directors Compensation:
    1. NONE

    License Fee Payments, Technology or Inventions:
    1. NONE

    Royalty Payments, Technology or Inventions:
    1. NONE

    Stock/Stock Options, Research Sponsor:
    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:
    1. NONE

    Legal Proceedings:
    1. NONE

  7. Richard J. Barohn, MD,
  8. Scientific Advisory Boards:
    1. NONE

    Gifts:
    1. NONE

    Funding for Travel or Speaker Honoraria:
    1. NONE

    Editorial Boards:
    1. NONE

    Patents:
    1. NONE

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. NONE

    Consultancies:
    1. NONE

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. NONE

    Research Support, Government Entities:
    1. NONE

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. NONE

    Stock/Stock Options/Board of Directors Compensation:
    1. NONE

    License Fee Payments, Technology or Inventions:
    1. NONE

    Royalty Payments, Technology or Inventions:
    1. NONE

    Stock/Stock Options, Research Sponsor:
    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:
    1. NONE

    Legal Proceedings:
    1. NONE

  9. Vidhya Gopalakrishnan, PhD,
  10. Scientific Advisory Boards:
    1. NONE

    Gifts:
    1. NONE

    Funding for Travel or Speaker Honoraria:
    1. NONE

    Editorial Boards:
    1. NONE

    Patents:
    1. NONE

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. NONE

    Consultancies:
    1. NONE

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. NONE

    Research Support, Government Entities:
    1. NONE

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. NONE

    Stock/Stock Options/Board of Directors Compensation:
    1. NONE

    License Fee Payments, Technology or Inventions:
    1. NONE

    Royalty Payments, Technology or Inventions:
    1. NONE

    Stock/Stock Options, Research Sponsor:
    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:
    1. NONE

    Legal Proceedings:
    1. NONE

  11. Merit Cudkowicz, MD,
  12. Scientific Advisory Boards:
    1. NONE

    Gifts:
    1. NONE

    Funding for Travel or Speaker Honoraria:
    1. NONE

    Editorial Boards:
    1. NONE

    Patents:
    1. NONE

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. NONE

    Consultancies:
    1. NONE

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. NONE

    Research Support, Government Entities:
    1. NONE

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. NONE

    Stock/Stock Options/Board of Directors Compensation:
    1. NONE

    License Fee Payments, Technology or Inventions:
    1. NONE

    Royalty Payments, Technology or Inventions:
    1. NONE

    Stock/Stock Options, Research Sponsor:
    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:
    1. NONE

    Legal Proceedings:
    1. NONE

  13. Jane R. Zhang, BS,
  14. Scientific Advisory Boards:
    1. NONE

    Gifts:
    1. NONE

    Funding for Travel or Speaker Honoraria:
    1. NONE

    Editorial Boards:
    1. NONE

    Patents:
    1. NONE

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. NONE

    Consultancies:
    1. NONE

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. NONE

    Research Support, Government Entities:
    1. NONE

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. NONE

    Stock/Stock Options/Board of Directors Compensation:
    1. NONE

    License Fee Payments, Technology or Inventions:
    1. NONE

    Royalty Payments, Technology or Inventions:
    1. NONE

    Stock/Stock Options, Research Sponsor:
    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:
    1. NONE

    Legal Proceedings:
    1. NONE

  15. Michael S. McGrath, MD, PhD,
  16. Scientific Advisory Boards:
    1. NONE

    Gifts:
    1. NONE

    Funding for Travel or Speaker Honoraria:
    1. NONE

    Editorial Boards:
    1. NONE

    Patents:
    1. NONE

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. NONE

    Consultancies:
    1. NONE

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. NONE

    Research Support, Government Entities:
    1. NONE

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. NONE

    Stock/Stock Options/Board of Directors Compensation:
    1. NONE

    License Fee Payments, Technology or Inventions:
    1. NONE

    Royalty Payments, Technology or Inventions:
    1. NONE

    Stock/Stock Options, Research Sponsor:
    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:
    1. NONE

    Legal Proceedings:
    1. NONE

  17. Elizabeth Ludington, PhD,
  18. Scientific Advisory Boards:
    1. NONE

    Gifts:
    1. NONE

    Funding for Travel or Speaker Honoraria:
    1. NONE

    Editorial Boards:
    1. NONE

    Patents:
    1. NONE

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. NONE

    Consultancies:
    1. NONE

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. NONE

    Research Support, Government Entities:
    1. NONE

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. NONE

    Stock/Stock Options/Board of Directors Compensation:
    1. NONE

    License Fee Payments, Technology or Inventions:
    1. NONE

    Royalty Payments, Technology or Inventions:
    1. NONE

    Stock/Stock Options, Research Sponsor:
    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:
    1. NONE

    Legal Proceedings:
    1. NONE

  19. Stan H. Appel, MD and
  20. Scientific Advisory Boards:
    1. NONE

    Gifts:
    1. NONE

    Funding for Travel or Speaker Honoraria:
    1. NONE

    Editorial Boards:
    1. NONE

    Patents:
    1. NONE

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. NONE

    Consultancies:
    1. NONE

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. NONE

    Research Support, Government Entities:
    1. NONE

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. NONE

    Stock/Stock Options/Board of Directors Compensation:
    1. NONE

    License Fee Payments, Technology or Inventions:
    1. NONE

    Royalty Payments, Technology or Inventions:
    1. NONE

    Stock/Stock Options, Research Sponsor:
    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:
    1. NONE

    Legal Proceedings:
    1. NONE

  21. Ari Azhir, PhD
  22. Scientific Advisory Boards:
    1. NONE

    Gifts:
    1. NONE

    Funding for Travel or Speaker Honoraria:
    1. NONE

    Editorial Boards:
    1. NONE

    Patents:
    1. NONE

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. NONE

    Consultancies:
    1. NONE

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. NONE

    Research Support, Government Entities:
    1. NONE

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. NONE

    Stock/Stock Options/Board of Directors Compensation:
    1. NONE

    License Fee Payments, Technology or Inventions:
    1. NONE

    Royalty Payments, Technology or Inventions:
    1. NONE

    Stock/Stock Options, Research Sponsor:
    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:
    1. NONE

    Legal Proceedings:
    1. NONE

    1. From the California Pacific Medical Center (R.G.M., J.S.K.), San Francisco, CA; Neuraltus Pharmaceuticals, Inc. (G.B., V.G., M.S.M., A.A.), Palo Alto, CA; University of Kansas (R.J.B.), Kansas City; Massachusetts General Hospital (M.C.), Boston; University of California, San Francisco (R.Z., M.S.M.); Agility Clinical, Inc. (E.L.), Carlsbad, CA; and The Methodist Hospital (S.H.A.), Houston, TX.
    1. Correspondence to Dr. Miller: millerrx{at}sutterhealth.org
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