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July 2017; 4 (4) ArticleOpen Access

Safety/tolerability of the anti-semaphorin 4D antibody VX15/2503 in a randomized phase 1 trial

Christopher LaGanke, Lawrence Samkoff, Keith Edwards, Lily Jung Henson, Pavle Repovic, Sharon Lynch, Lael Stone, David Mattson, Aaron Galluzzi, Terrence L. Fisher, Christine Reilly, Laurie A. Winter, John E. Leonard, Maurice Zauderer
First published June 16, 2017, DOI: https://doi.org/10.1212/NXI.0000000000000367
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Article Information

vol. 4 no. 4 e367
DOI: 
https://doi.org/10.1212/NXI.0000000000000367
PubMed: 
28642891
Published By: 
Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology
Online ISSN: 
2332-7812
History: 
  • Received November 8, 2016
  • Accepted in final form April 28, 2017
  • First Published June 16, 2017.
Copyright & Usage: 
Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND), which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Author Disclosures

    1. Christopher LaGanke, MD,
    2. Lawrence Samkoff, MD,
    3. Keith Edwards, MD,
    4. Lily Jung Henson, MD,
    5. Pavle Repovic, MD,
    6. Sharon Lynch, MD,
    7. Lael Stone, MD,
    8. David Mattson, MD,
    9. Aaron Galluzzi, MSc,
    10. Terrence L. Fisher, PhD,
    11. Christine Reilly, BS,
    12. Laurie A. Winter, BS,
    13. John E. Leonard, PhD and
    14. Maurice Zauderer, PhD
  1. Christopher LaGanke, 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

  2. Lawrence Samkoff, MD,
    3. 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. Samkoff, LM. and Goodman, AD (eds) (2014), Multiple Sclerosis and CNS Inflammatory Disorders, West Sussex, England: John Wiley & Sons, Ltd, 2014.

    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. Keith Edwards, MD,
    4. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. (1) Biogen, travel reimbursement for speaker (2) Genzyme, travel reimbursement for speaker (3) Novartis, travel reimbursement for speaker Resigned from all speaker talks as of June 2016

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. MS Center of Northeastern NY, Director, 2007-current

    Consultancies:

    1. (1) Biogen (2) Genzyme (3) EMD Serono (4) Novartis Resigned from all consultancies as of June 2016

    Speakers' Bureaus:

    1. (1) Biogen (2) Genzyme (3) Novartis Resigned from all speaker bureaus as of June 2016

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. (1) Actelion (2) Biogen (3) Envivo Pharmaceuticals (4) Eisai Inc (5) Genentech (6) Genzyme (7) Hoffman-La Roche (8) Novartis (9) Pfizer (10) Vaccinex

    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

  4. Lily Jung Henson, MD,
    5. Scientific Advisory Boards:

    1. 1. Genzyme

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. 1. Genzyme (travel/honoraria)

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. Piedmont, Chief of Neurology, 1 year (2015-2016) Piedmont, Chief Medical Officer, 1year (2015-present) Swedish Health Services, neurologist, 11 years (2004-2015) Swedish Health Services, VPMA, 1 year (2014-2015)

    Consultancies:

    1. Biomarin Mitsubishi Tanabe

    Speakers' Bureaus:

    1. Genzyme Novartis Teva Pfizer Serono

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Genzyme Biogen Novartis Opexa Parexel (spouse)

    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. Merck (stock, > 25 years) Amgen (stock, 1 year)

    Legal Proceedings:

    1. expert witness for both defense and plaintiff (do not have list of firms)

  5. Pavle Repovic, 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. (1) Biogen, (2) sanofi genzyme, (3) Teva, (4) EMD Serono, (5) Novartis, (6) Anvil biosciences

    Speakers' Bureaus:

    1. (1) Biogen, (2) sanofi genzyme, (3) Teva, (4) EMD Serono, (5) Novartis, (6) Pfizer, (7) Acorda

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. (1) Novartis

    Research Support, Government Entities:

    1. (1) NIH #NS077309 co-principal investigator, 2014-present

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. (1) Guthy-Jackson Charitable Foundation

    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

  6. Sharon Lynch, MD,
    7. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. MS-CURE Non-profit, speaker Honorarium

    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. Novartis, Alexion, Acorda, Actelion, biogen, Sanofi, roche, Genentech, Chugai, Medimmune, Vaccinex, Sun Pharma, Teva,Genzyme, MedDay, Opexa

    Research Support, Government Entities:

    1. NIH- NN102 Investigator, 2013-2017

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. National Multiple Sclerosis Society

    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. Lael Stone, MD,
    8. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. Editor in Chief, International Journal Of MS Care, 2008- ongoing

    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. National Multiple Sclerosis Society

    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

  8. David Mattson, MD,
    9. Scientific Advisory Boards:

    1. Acorda Therapeutics, Biogen

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. Teva Neuroscience, speaker honoraria; Biogen, speaker honoraria, travel; EMD-Serono, speaker honoraria, travel; Pfizer, speaker honoraria, travel; Acorda Therapeutics, speaker honoraria, travel; Novartis, speaker honoraria, travel; Genzyme, speaker honoraria, travel; Bayer, speaker honoraria; Questcorp, speaker honoraria

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. Teva Neuroscience, Biogen-Idec, EMD-Serono, Pfizer, Acorda Therapeutics, Novartis, Genzyme, Bayer, Questcorp

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Teva Neuroscience, Biogen , MedImmune, Roche, ONO, Acorda Therapeutics, Genentech, Novartis, Genzyme, Sanofi- Aventis, Actelion, Vaccinex, Alkermes

    Research Support, Government Entities:

    1. Indiana Clinical Translational Science Institute/NIH, TL1 TR000162, Co-PI, 5/1/2008-4/30/2014

    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. Aaron Galluzzi, MSc,
    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. Premier Research, Principal Biostatistician, 2016-present Chiltern International, Senior Biostatistician, 2015-2016 PRA Health Sciences, Senior Biostatistician, 2014-2015

    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

  10. Terrence L. Fisher, PhD,
    11. 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. Christine Reilly, BS,
    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. 1)Vaccinex Inc, Senior Research Scientist, 13yrs

    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

  12. Laurie A. Winter, BS,
    13. 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. Current:Senior ScientistOrtho Clinical DiagnosticsEmployed Since May 2016-presentCurrent position/work is not associated with this manuscript. The work associated with this manuscript was from my tenure with Vaccinex prior to May 2016.

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Ortho Clinical Diagnostics (May 2016-present) in the form of employment compensation.

    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. John E. Leonard, PhD and
    14. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. Anderson, D.R., Hanna, N., Leonard, J.E., Newman, R.A. andReff, M.E. Therapeutic application of chimeric antibodyto human B lymphocyte restricted differentiation antigenfor treatment of B cell lymphoma. Filed November 13,1992, U.S. Patent and Trademark Office.Anderson, D.R., Leonard, J.E., Newman, R.A., Reff, M.E,and Rastetter, W.H. Therapeutic Application of Chimericand Radiolabeled Antibodies to Human B LymphocyteRestricted Differentiation Antigen for Treatment of B CellLymphoma, December 1, 1998, U.S. Patent and TrademarkOffice, Patent No. 5,843,439.Anderson, D.R.., Hanna, N., Leonard, J.E., Newman, R.A.,Reff, M.E, and Rastetter, W.H. Therapeutic Applicationsof Chimeric and Radiolabeled Antibodies to Human BLymphocyte Restricted Differentiation Antigen forTreatment of B Cell Lymphoma, January 27, 2004, U.S.Patent and Trademark Office, Patent No. 6,682,734.Anderson, D.R.., Hanna, N., Leonard, J.E., Newman, R.A.,Rastetter, W.H and, Reff, M.E, Chimeric Anti-CD20Antibody, October 13, 2008, European Patent Office, PatentNo., 08012898.5 ? 2404.Anderson, D.R., D.R., Hanna, N., Leonard, J.E., Newman,R.A., Reff, M.E, and Rastetter, W.H. Expression and Useof Anti-CD20 Antibodies, June 29, 2010, U.S. Patent andTrademark Office, Patent No. 7,744,877 B2.Leonard, JE, et al, Use of Chimeric Anti-CD20 Antibody asIn Vitro or In Vivo Purging Agent in Patients ReceivingBone Marrow Transplantation or Peripheral Blood Stem CellTransplant; June 10, 2013, U.S. Patent and TrademarkOffice, Patent No. 13/914,421.

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. Vaccinex, IncSenior Vice President, Development2009 to Present

    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. Vaccinex, Inc2009 to Present

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  14. Maurice Zauderer, PhD
    15. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. 1. Use of anti-semaphorin 4D antibody to treat cancer 2. Use of anti-semaphorin 4D antibody to treat neuroinflammatory/neurodegenerative diseases

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. Vaccinex, Inc., Chief Executive Officer & President, 19 years

    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. Vaccinex, Inc. 1998 to present

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  1. Author affiliations are provided at the end of the article.
  1. Correspondence to Dr. Leonard: jleonard{at}vaccinex.com
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Your role and/or occupation, e.g. 'Orthopedic Surgeon'.
Your organization or institution (if applicable), e.g. 'Royal Free Hospital'.
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NOTE: All authors, besides the first/corresponding author, must complete a separate Publishing Agreement Form and provide via email to the editorial office before comments can be posted.
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