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Resolution of Organ Dysfunction as a Predictor of Long-Term Survival in Necrotizing Soft Tissue Infections: Analysis of the ACCUTE Trial and a Retrospective Claims-Linked Database Study

Scott C Brakenridge , David A Wilfret, Greg Maislin, Katherine E Andrade, Valery Walker, Addison K May, Wayne M Dankner, Eileen M Bulger

J Trauma Acute Care Surg. 2021 Mar 23.

doi: 10.1097/TA.0000000000003183.



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Estimating the Impact of Necrotizing Soft Tissue Infections in the United States: Incidence and Re-Admissions

Addison K. May, Victor B. Talisa, David A. Wilfret,  Eileen Bulger, Wayne Dankner, Andrew Bernard, and Sachin Yende

Surgical Infections. Volume 21. August 2020 ePublication.

DOI: 10.1089/sur.2020.099

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A Novel Immune Modulator for Patients with Necrotizing Soft Tissue Infections (NSTI): Results of a Multicenter, Phase 3 Randomized Controlled Trial of Reltecimod (AB 103)

Eileen M. Bulger, MD, Addison K. May, MD, Bryce R. H. Robinson, MD, David C. Evans, MD, Sharon Henry, MD, John M. Green, MD, Eric Toschlog, MD, Jason L. Sperry, MD, Peter Fagenholz, MD, Niels D. Martin, MD, Wayne M. Dankner, MD, Greg Maislin, PhD, David Wilfret, MD, and Andrew C. Bernard, MD, on behalf of the ACCUTE Study Investigators

Ann Surg. 2020; 272(3):469-478.

doi: 10.1097/SLA.0000000000004102


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Prolonged Benefit of Reltecimod Despite Short Plasma Half-Life

Rotem Edgar, Avi Cohen, Dalia Hillman, Raymond Kaempfer, and Anat Shirvan

International Journal of Peptide Research and Therapeutics,doi: 10.1007/s10989-020-10033-7

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Treatment with One Dose of Reltecimod is Superior to Two Doses in Mouse Models of Lethal Infection

Rotem Edgar, Margarite L. Tarrio, Greg, Maislin, Feng Chiguang, Raymond, Kaempfer, Alan Cross, Steven M. Opal and Anat Shirvan

International Journal of Peptide Research and Therapeutics,doi: 10.1007/s10989-019-09974-5

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Treatment With Reltecimod Significantly Reduces Inflammation in Mouse Model of Acute Pancreatitis

R. Dawra, Z. Yuan, V. Dudeja, R. Edgar, A. Shirvan, and A. Saluja

50th American Pancreatic Association meeting, November 6-9,  2019

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Atox Bio targeting severe infections with reltecimod; trials in AKI, NSTI ongoing

Elise Mak

BioWorld, May 31, 2018

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Reltecimod. T-cell-specific surface glycoprotein CD28 (TP44) antagonist CD28 homodimer interface mimetic peptide Treatment of necrotizing soft-tissue infection

A. Shirvan, E. Bulger and W. Dankner

Drugs of the Future  2018, 43(4): 243

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Prolonged benefit of Reltecimod in treatment of patients with NSTI is independent of brief plasma half-life

A. Shirvan, R. Edgar; D. Hillman, R. Kaempfer

Presentation at the Surgical Infection Society 38th Annual Meeting 2018

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Early and sustained normalization of hyper-inflammatory response is associated with improved survival after a single dose administration of Reltecimod (Reltecimod), a CD28 peptide antagonist, in a mice model of polymicrobial sepsis

A. Shirvan, R. Edgar, J. Palardy, M. Tarrio, G. Maislin, S. Opal

Intensive Care Medicine Experimental 2017, 5(Suppl 2):0193

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Validation of a Clinical Trial Composite Endpoint for Patients with Necrotizing Soft Tissue Infections

Bulger, Eileen M. MD; May, Addison MD; Dankner, Wayne MD; Maislin, Greg PhD; Robinson, Bryce MD, MS; Shirvan, Anat PhD

Journal of Trauma and Acute Care Surgery: Oct 2017, Volume 83 -issue4, p 622-627
doi: 10.1097/TA.0000000000001564

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Impact and Progression of Organ Dysfunction in Patients with Necrotizing Soft Tissue Infections: A Multicenter Study

Bulger EM, May A, Bernard A, Cohn S, Evans DC, Henry S, Quick J, Kobayashi L, Foster K, Duane TM, Sawyer RG, Kellum JA, Maung A, Maislin G, Smith DD, Segalovich I, Dankner W, Shirvan A.

Surg Infect (Larchmt). 2015 Dec;16(6):694-701

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CD28 homodimer interface mimetic peptide acts as a preventive and therapeutic agent in models of severe bacterial sepsis and Gram-negative bacterial peritonitis

Girish Ramachandran, Raymond Kaempfer, Chun-Shiang Chung, Anat Shirvan, Abdullah B. Chahin, John E. Palardy, Nicolas A. Parejo, Yaping Chen, Melissa Whitford, Gila Arad, Dalia Hillman, Ronen Shemesh, William Blackwelder, Alfred Ayala, Alan S. Cross,Steven M. Opal

J Infect Dis. 2015 Mar 15;211(6):995-1003

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Single Administration of p2TA (Reltecimod), a CD28 Antagonist Peptide, Prevents Inflammatory and Thrombotic Reactions and Protects against Gastrointestinal Injury in Total-Body Irradiated Mice

Salida Mirzoeva, Tatjana Paunesku, M. Beau Wanzer, Anat Shirvan, Raymond Kaempfer, Gayle E. Woloschak, William Small Jr.

PLoS One. 2014 Jul 23;9(7):e101161

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A Novel Drug for Treatment of Necrotizing Soft-Tissue Infections

Eileen M. Bulger, MD; Ronald V. Maier, MD; Jason Sperry, MD; Manjari Joshi, MD; Sharon Henry, MD; Frederick A. Moore, MD; Lyle L. Moldawer, PhD; Demetrios Demetriades, MD; Peep Talving, MD; Martin Schreiber, MD; Bruce Ham, MD; Mitchell Cohen, MD; Steven Opal, MD; Irit Segalovich, BS; Greg Maislin, MSc; Raymond Kaempfer, PhD; Anat Shirvan, PhD

JAMA Surg. 2014 Jun;149(6):528-36

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Effects of T-Cell Immune Modulator Reltecimod on Experimental Sepsis-induced Acute Kidney Injury

Xiaojian Wan, MD; PhD; Xiaoyan Wen, MD,M.Sc; Anat Shirvan, PhD; Raymond Kaempfer, PhD; Zhiyong Peng, MD, PhD; John A. Kellum, MD, MCCM

CRRT 2014.

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A Peptide Antagonist of CD28 Signaling Attenuates Toxic Shock and NecrotizingSoft-Tissue Infection Induced byStreptococcus pyogenes

Girish Ramachandran, Mohan E. Tulapurkar, Kristina M. Harris, Gila Arad, Anat Shirvan, Ronen Shemesh,Louis J. DeTolla,Cinzia Benazzi, Steven M. Opal, Raymond Kaempfer,a and Alan S. Cross,a

J Infect Dis. 2013 Jun 15;207(12):1869-77.

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Reltecimod, a CD28 antagonist peptide, a new therapeutic agent in model of severe sepsis.

Anat Shirvan, Chun-Shiang Chung, Alfred Ayala, Steve Opal, Abdullah Chahin and Dan Teleman,

Sepsis 2011 Symposium.

Binding of Superantigen Toxins into the CD28 Homodimer Interface Is Essential for Induction of Cytokine Genes That Mediate Lethal Shock.

Bacterial superantigens, a diverse family of toxins, induce an inflammatory cytokine storm that can lead to lethal shock.

PLoS Biol. 2015 Aug;13(8):e1002237.

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CD28 mimetic peptide treatment for superantigen- and endotoxin-induced lethal shock.

Alan Cross, Girish Ramachandran, Melissa Whitford, Gila Arad , Raymond Kaempfer and Steve Opal

American Society of Microbiology, New Orleans, US, 2011.

Novel peptide antagonist therapy for superantigen and endotoxin-induced lethal shock.

Girish Ramachandran, Steven Opal, Melissa Whitford, Gila Arad, Raymond Kaempfer and Alan Cross

International Endotoxin and Innate Immunity Society/Society of Leukocyte Biology, Vancouver, Canada, 2010.

Israel’s Atox aiming at inflammation in community acquired pneumonia, CAP-ping Inflammation.

Published on Monday, October 11, 2010, BioCentury on BioBusiness.

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Broad-spectrum immunity against superantigens is elicited in mice protected from lethal shock by a superantigen antagonist peptide.

Arad G, Hillman D, Levy R, Kaempfer R. (2004)

Immunol Lett. 2004 Feb 15;91(2-3):141-5

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Peptide antagonists of superantigen toxins.

Kaempfer R.

Mol Divers. 2004;8(2):113-20

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Biodefense strategies against superantigen toxins. In Terror and Medicine: Medical aspects of biological, chemical and radiological terrorism.

Kaempfer R, Arad G. (Shemer, J. and Shoenfeld, Y., Eds),

Pabst Science Publishers, Lengerich, Germany, pp. (2003):228-240.

Defense against biologic warfare with superantigen toxins.

Kaempfer R, Arad G, Levy R, Hillman D.

Isr Med Assoc J.(2002): 520-3.

Superantigen concomitantly induces Th1 cytokine genes and the ability to shut off their expression on re-exposure to superantigen.

Arad G, Levy R, Kaempfer R.

Immunol Lett. (2002) :82,75-78.

Superantigen antagonist blocks Th1 cytokine gene induction and lethal shock.

Arad G, Hillman D, Levy R, Kaempfer R. (2001)

J Leukoc Biol. 69, (2001): 921-927.

Superantigen antagonist protects against lethal shock and defines a new domain for T-cell activation.

Arad G, Levy R, Hillman D, Kaempfer R.

Nat Med. 6, (2000): 414-421.