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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.

Atox Bio Announces Exercise by BARDA of Next Option Period to Support Continued Development of Reltecimod for NSTI

June 18, 2019

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Atox Bio Announces Appointment of Robert Greif as Chief Commercial Officer

February 14, 2019

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Atox Bio Announces Independent Safety Monitoring Committee Recommendation To Continue Phase 3 Study Of Reltecimod In Necrotizing Soft Tissue Infections

September 25, 2018

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Atox Bio Announces Enrollment of First Patient in Phase 2 Study of Acute Kidney Injury (AKI)

May 29, 2018

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Atox Bio Closes $30 Million Investment

December 4, 2017

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Atox Bio Awarded Next Milestone – based Option by BARDA to Support Continued Development of Reltecimod for Necrotizing Soft Tissue Infections

September 25, 2017

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Atox Bio’s Reltecimod Passes Futility Analysis in Phase 3 ACCUTE Study; Trial Continues as Planned

May 23, 2017

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Atox Bio Announces Independent Safety Monitoring Committee Recommendation To Continue Phase 3 Study Of Reltecimod In Necrotizing Soft Tissue Infections

November 3, 2016

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Atox Bio Awarded Next Milestone-based Option by BARDA to Support Development of Reltecimod for Necrotizing Soft Tissue Infections

June 15, 2016

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Appetite suppressor? Atox flesh-eating bug phase III dials down immune reply

December 8, 2015

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Atox Bio Enrolls First Patient in Phase 3 Study of Potential Treatment for Necrotizing Soft Tissue Infection (Flesh Eating Bacteria)

December 7, 2015

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Atox Bio Announces Appointment of Biotech Veteran Daniel D. Burgess as Chairman of the Board

December 15, 2014

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Atox Bio Awarded Contract worth up to $24 Million for the Development of Reltecimod by the Biomedical Advanced Research and Development Authority (BARDA)

September 29, 2014

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Reltecimod granted orphan medicinal product designation in the European Union for the treatment of necrotizing soft tissue infections (NSTI)

August 4, 2014

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Atox Bio Closes $23 Million Investment

July 24, 2014

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Atox Bio Publishes Data Demonstrating the Broad Therapeutic Effect of its Flagship Product in Treating “Flesh Eating Bacteria”

April 10, 2013

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Atox Bio Announces Positive Top Line Results in the Reltecimod Necrotizing Soft Tissue Infections (NSTI) Phase 2a Trial

November 20, 2012

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FDA grants Fast Track designation to Atox Bio’s Reltecimod for the treatment of necrotizing soft tissue infections (NSTI)

September 10, 2012

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Atox Bio Raises $3.25 million to Advance Development of Reltecimod, a Novel Therapy for the Treatment of Severe Bacterial Infections, Currently in Phase 2 Clinical Trials

December 20, 2011

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Atox Bio granted orphan drug designation for Reltecimod for the treatment of necrotizing soft tissue infections (NSTI)

October 25, 2011

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End of Phase 1-Atox Bio announces successful completion of phase 1 for Reltecimod, a novel immunomodulator being developed for severe bacterial infections and sepsis

May 12, 2011

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Atox Bio raises $2.1 Million to advance development of Reltecimod, a novel therapy for the treatment of severe bacterial infections

October 14, 2010

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