Phil Shale
5 Papers
4 Citations
Phil Shale is an academic researcher. The author has contributed to research in topics: Duchenne muscular dystrophy & Randomized controlled trial. The author has an hindex of 4, co-authored 4 publications.
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Papers
Phase IIa trial in Duchenne muscular dystrophy shows vamorolone is a first-in-class dissociative steroidal anti-inflammatory drug.
Laurie S. Conklin,Jesse M. Damsker,Eric P. Hoffman,William J. Jusko,Panteleimon D. Mavroudis,Benjamin D Schwartz,Laurel J Mengle-Gaw,Edward C. Smith,Jean K. Mah,Michela Guglieri,Yoram Nevo,Nancy L. Kuntz,Craig M. McDonald,Mar Tulinius,Monique M. Ryan,Richard Webster,Diana Castro,Richard S. Finkel,Andrea L. Smith,Lauren P. Morgenroth,Antonio Arrieta,Maya Shimony,Mark Jaros,Phil Shale,John M. McCall,Yetrib Hathout,Kanneboyina Nagaraju,John N. van den Anker,Leanne M Ward,Alexandra Ahmet,Michaelyn R. Cornish,Paula R. Clemens +31 more
TL;DR: The development of the first dissociative steroid that preserves anti‐inflammatory efficacy and decreases steroid‐associated safety concerns is demonstrated, with an array of pre‐selected biomarkers in multiple contexts of use.
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Vamorolone trial in Duchenne muscular dystrophy shows dose-related improvement of muscle function.
Eric P. Hoffman,Benjamin D Schwartz,Laurel J Mengle-Gaw,Edward C. Smith,Diana Castro,Jean K. Mah,Craig M. McDonald,Nancy L. Kuntz,Richard S. Finkel,Michela Guglieri,Katharine Bushby,Mar Tulinius,Yoram Nevo,Monique M. Ryan,Richard D. Webster,Andrea L. Smith,Lauren P. Morgenroth,Antonio Arrieta,Maya Shimony,Catherine Siener,Mark Jaros,Phil Shale,John M. McCall,Kanneboyina Nagaraju,John N. van den Anker,Laurie S. Conklin,Avital Cnaan,Heather Gordish-Dressman,Jesse M. Damsker,Paula R. Clemens +29 more
TL;DR: This study provides Class IV evidence that for boys with DMD, vamorolone demonstrated possible efficacy compared to a natural history cohort of glucocorticoid-naive patients and appeared to be tolerated.
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Efficacy and Safety of Vamorolone vs Placebo and Prednisone Among Boys With Duchenne Muscular Dystrophy
Michela Guglieri,Paula R. Clemens,Seth J. Perlman,Edward C. Smith,Iain Horrocks,Richard S. Finkel,Jean K. Mah,Nicolas Deconinck,Nathalie Goemans,Jana Haberlová,Volker Straub,L. Mengle-Gaw,Benjamin D. Schwartz,Amy Harper,Perry B. Shieh,Liesbeth De Waele,Diana Castro,Michelle Yang,Monique M. Ryan,Craig M. McDonald,Mar Tulinius,Richard D. Webster,Hugh J. McMillan,Nancy L. Kuntz,Vashmi K Rao,Giovanni Baranello,Stefan Spinty,Anne-Marie Childs,Anne Marie Sbrocchi,Kathryn Selby,Migvis Monduy,Yoram Nevo,Juan Vilchez-Padilla,A. Nascimento-Osorio,Erik H. Niks,Imelda J. M. de Groot,Marina Katsalouli,M. James,John N. van den Anker,Jesse M. Damsker,Alexandra Ahmet,Leanne M Ward,Mark J. Jaros,Phil Shale,U. Dang,Eric P. Hoffman +45 more
TL;DR: This randomized clinical trial investigates the efficacy and safety of partial receptor agonist vamorolone compared with placebo and prednisone in boys with Duchenne muscular dystrophy.
Phase IIa trial in Duchenne Muscular Dystrophy shows vamorolone is a firs-in-class dissociative steroidal anti-inflammatory drug.
Laurie S. Conklin,Jesse M. Damsker,Eric P. Hoffman,William J. Jusko,Panteleimon D. Mavroudis,Benjamin D Schwartz,Laurel J Mengle-Gaw,Edward C. Smith,J. Mah,Michela Guglieri,Y Nego,Nancy L. Kuntz,Craig M. McDonald,T Mar,Monique M. Ryan,Richard Webster,Diana Castro,Richard S. Finkel,Andrea L. Smith,Lauren P. Morgenroth,Arrieta Aa,Maya Shimony,Mark Jaros,Phil Shale,JM MdDall,null Hathout,K Magaraju,den Anker J van,Leanne M Ward,Alexandra Ahmet,HR Cornish,Paula R. Clemens +31 more
- 01 Jan 2018
TL;DR: In this article, the authors reported a first-in-patient study of vamorolone, a dissociative steroidal anti-inflammatory drug, in Duchenne muscular dystrophy.
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Efficacy and safety of vamorolone in Duchenne muscular dystrophy: An 18-month interim analysis of a non-randomized open-label extension study
Edward C. Smith,Laurie S. Conklin,Eric P. Hoffman,Paula R. Clemens,Jean K. Mah,Richard S. Finkel,Michela Guglieri,Mar Tulinius,Yoram Nevo,Monique M. Ryan,Richard Webster,Diana Castro,Nancy L. Kuntz,Laurie Kerchner,Lauren P. Morgenroth,Antonio Arrieta,Maya Shimony,Mark Jaros,Phil Shale,Heather Gordish-Dressman,Laura Hagerty,Utkarsh J. Dang,Jesse M. Damsker,Benjamin D Schwartz,Laurel J Mengle-Gaw,Craig M. McDonald,Dnhs Investigators +26 more
TL;DR: It was found that vamorolone treatment was associated with improvements in some motor outcomes as compared with corticosteroid-related improvements as well as with published incidences for prednisone and deflazacort.