Evidence map›Paper›PMID 27015977›Full record

Trial reportJournal of biotechnology2016

A novel approach for emerging and antibiotic resistant infections: Innate defense regulators as an agnostic therapy.

John R North, Shunsuke Takenaka, Annett Rozek, Agnieszka Kielczewska, Steven Opal, Lisa A Morici, B Brett Finlay, Christopher J Schaber, Richard Straube, Oreola Donini

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Journal of biotechnology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03237325 (A Pivotal, Double-Blind, Randomized, Placebo-Controlled, Multinational Study of SGX942), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.6field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03237325 phase3completednot on this mapstarted 2017, after this paper: background citation

A Pivotal, Double-Blind, Randomized, Placebo-Controlled, Multinational Study of SGX942 (Dusquetide) for the Treatment of Oral Mucositis in Patients Being Treated With Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck

TypeinterventionalSponsorSoligenixRan2017 to 2021Enrolled266ConditionsSquamous Cell Carcinoma of the Oral Cavity and Oropharynx, Oral MucositisArmsSGX942, Placebo
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 30 citations in OpenAlex.

  1. Climate change and antimicrobial resistance.Nature reviews. Microbiology · 2026
    Review
  2. Review
  3. Unraveling the complexity of radiotherapy- and chemotherapy-induced oral mucositis: insights into pathogenesis and intervention strategies.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Review
  4. Review
  5. Article
  6. Article
  7. Review
  8. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 2 countries.

John R NorthInimex Pharmaceuticals Inc., 8540 Baxter Place, Burnaby, BC V5A 4T8, Canada.
Shunsuke TakenakaInimex Pharmaceuticals Inc., 8540 Baxter Place, Burnaby, BC V5A 4T8, Canada.
Annett RozekInimex Pharmaceuticals Inc., 8540 Baxter Place, Burnaby, BC V5A 4T8, Canada.
Agnieszka KielczewskaInimex Pharmaceuticals Inc., 8540 Baxter Place, Burnaby, BC V5A 4T8, Canada.
Steven OpalThe Warren Alpert Medical School of Brown University, Pawtucket, RI 02912, United States.
Lisa A MoriciTulane University School of Medicine, 1430 Tulane Avenue #8010, New Orleans, LA 70112, United States.
B Brett FinlayUniversity of British Columbia, Vancouver, BC V6T 1Z4, Canada.
Christopher J SchaberSoligenix Inc., 29 Emmons Drive, Suite C-10, Princeton, NJ, 08540, United States.
Richard StraubeSoligenix Inc., 29 Emmons Drive, Suite C-10, Princeton, NJ, 08540, United States.
Oreola DoniniInimex Pharmaceuticals Inc., 8540 Baxter Place, Burnaby, BC V5A 4T8, Canada; Soligenix Inc., 29 Emmons Drive, Suite C-10, Princeton, NJ, 08540, United States. Electronic address: odonini@soligenix.com.
Inimex Pharmaceuticals (Canada) · CASoligenix (United States) · USBrown University · USTulane University · USUniversity of British Columbia · CA

Funding

Innate Defense Regulator Peptide as a Therapeutic for Acute Pneumonic MelioidosisR43AI108175 · NIAID · SOLIGENIX, INC. · PI SCHABER, CHRISTOPHER JOSEPH · 2014 to 2014
$300k
NIAID NIH HHS R43 AI108175
6 · The paper itself

Abstract

Innate Defense Regulators (IDRs) are short synthetic peptides that target the host innate immune system via an intracellular adaptor protein which functions at key signaling nodes. In this work, further details of the mechanism of action of IDRs have been discovered. The studies reported here show that the lead clinical IDR, SGX94, has broad-spectrum activity against Gram-negative and Gram-positive bacterial infections caused by intracellular or extracellular bacteria and also complements the actions of standard of care antibiotics. Based on in vivo and primary cell culture studies, this activity is shown to result from the primary action of SGX94 on tissue-resident cells and subsequent secondary signaling to activate myeloid-derived cells, resulting in enhanced bacterial clearance and increased survival. Data from non-clinical and clinical studies also show that SGX94 treatment modulates pro-inflammatory and anti-inflammatory cytokine levels, thereby mitigating the deleterious inflammatory consequences of innate immune activation. Since they act through host pathways to provide both broad-spectrum anti-infective capability as well as control of inflammation, IDRs are unlikely to be impacted by resistance mechanisms and offer potential clinical advantages in the fight against emerging and antibiotic resistant bacterial infections.

Indexed as

Drug Resistance, MicrobialImmunity, InnateAdolescentAdultAnimalsAnti-Bacterial AgentsAnti-Inflammatory AgentsCell MovementCytokinesFemaleHalf-LifeHumansMacaca fascicularisMaleMethicillin-Resistant Staphylococcus aureusMice, Inbred BALB CAnti-Bacterial AgentsAnti-Inflammatory AgentsCytokinesAntibacterialAnti-infectiveAnti-inflammatoryBroad spectrumCefepime (PubChem CID: 9571075)Doxycycline (PubChem CID: 54671203)Dusquetide (PubChem CID: 71722017)ImmuneInnateVancomycin (PubChem CID: 14969)

Identifiers

PMID27015977
PMCPMC4867239
OpenAlexW2302583646

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.