A Phase 2a, Randomized, Double-blind, Placebo-controlled Assessment of the Safety and Protective Efficacy of FF-3 Dry Powder Administered by Nasal Inhalation for 5 Days to Healthy Adult Subjects Who Are Experimentally Infected With a Challenge Strain of Influenza A Virus

The purpose of this study are to determine the effect FF-3 in comparison to placebo in subjects who are experimentally inoculated with a live, challenge strain of influenza A virus.

Start Date01 Sep 2015

Sponsor / Collaborator

Autoimmune Technologies LLC

[+1]

NCT01990846 / CompletedPhase 1

A Phase 1, Randomized, Double-blind, Placebo-controlled Assessment of the Safety, Tolerability and Pharmacokinetics of Escalating Single and Repeat Doses of Flufirvitide-3 Dry Powder for Inhalation in Healthy Subjects

To evaluate the safety, tolerability and pharmacokinetics (PK) of single,and repeat escalating doses of FF-3 dry powder administered via inhalation in healthy adult subjects

Start Date01 Mar 2014

Sponsor / Collaborator

Autoimmune Technologies LLC

NCT01313962 / CompletedPhase 1

A Phase 1, Randomized, Double-blind, Placebo-controlled Assessment of the Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of Flufirvitide-3 Nasal Spray in Healthy Subjects

The purpose of this study is to evaluate the safety and pharmacokinetic profile of flufirvitide-3 nasal spray in healthy subjects.

Start Date01 Aug 2011

Sponsor / Collaborator

Autoimmune Technologies LLC

100 Clinical Results associated with Autoimmune Technologies LLC

0 Patents (Medical) associated with Autoimmune Technologies LLC

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15 Oct 2016·Journal of Infectious DiseasesQ2 · MEDICINE

Field Validation of the ReEBOV Antigen Rapid Test for Point-of-Care Diagnosis of Ebola Virus Infection

Q2 · MEDICINE

Article

Author: Kargbo, Brima ; Koroma, Veronica J ; Nelson, Diana K S ; Boisen, Matthew L ; Baimba, Francis ; Momoh, Mambu ; Brown, Bethany L ; Grant, Donald S ; Pitts, Kelly R ; Schieffelin, John S ; Jones, Abby B ; Garry, Robert F ; Fonnie, Mbalu ; Pham, Ha ; Shaffer, Jeffrey G ; Millett, Molly M ; Gevao, Sahr M ; Gbetuwa, Momoh ; Hartnett, Jessica N ; Safa, Sidiki ; Gbakie, Michael ; Khan, Sheik H ; Branco, Luis M ; McCormick, Stephanie ; Oottamasathien, Darin ; Geisbert, Thomas W ; Fullah, Mohamed ; Wilson, Russell B ; Cross, Robert W ; Goba, Augustine ; Geisbert, Joan B

BACKGROUNDThe 2013-2016 West African Ebola virus disease (EVD) epidemic is the largest recorded. Triage on the basis of clinical signs had limited success, and the time to diagnosis by quantitative reverse transcription-polymerase chain reaction (qRT-PCR) could exceed 5 days. Here we describe the development and field validation of the ReEBOV Antigen Rapid Test (ReEBOV RDT) to aid triage of individuals with suspected EVD.METHODSSamples from patients with suspected EVD were submitted to Kenema Government Hospital, Sierra Leone, for Lassa fever and EVD screening throughout 2014. Banked residual clinical samples were tested in November 2014 and January 2015 in a blinded field trial to estimate the clinical effectiveness of the ReEBOV RDT, compared with EBOV-specific qRT-PCR.RESULTSPreliminary ReEBOV RDT performance demonstrated a positive percentage agreement (PPA) of 91.1% (195 of 214 results; 95% confidence interval [CI], 86.5%-94.6%) and a negative percentage agreement (NPA) of 90.2% (175 of 194; 95% CI, 85.1%-94.0%). The final estimates used by the Food and Drug Administration to determine whether to grant emergency use authorization for the test, which excluded a qRT-PCR reference method threshold cutoff, were a PPA of 62.1% (72 of 116 results; 95% CI, 52.6%-70.9%) and a NPA of 96.7% (58 of 60; 95% CI, 88.5%-99.6%), with a diagnostic likelihood of 18.6. A subsequent, independent evaluation by the World Health Organization generated results consistent with the preliminary performance estimates.CONCLUSIONSThe ReEBOV RDT demonstrated the potential to provide clinically effective rapid and accurate point-of-care test results and, thus, to be a powerful tool for increasing triage efficiency.

Journal of Rheumatology

Antipolymer antibody reactivity in a subset of patients with fibromyalgia correlates with severity

Author: Rice, Janet C. ; Tesser, John R. P. ; Bridges, Alan J. ; Meyer, Ann ; Wilson, Russell B. ; Gluck, Oscar S.

Objective.To determine the prevalence of antipolymer antibodies (APA) in patients with fibromyalgia (FM) and autoimmune disease control groups and to determine if the presence of these antibodies correlates with severity in patients with FM.Methods.Sera from patients with FM, osteoarthritis (OA), and rheumatoid arthritis (RA) were analyzed.Patients with implants of any kind and patients with concurrent autoimmune conditions were excluded from study.Banked sera from autoimmune disease controls including poly/dermatomyosis, RA, systemic lupus erythmatosus (SLE), and systemic sclerosis (SSc) were also analyzed.To determine if seroreactivity correlates with severity, banked sera from patients with FM assessed as severe or mild and from controls were assayed.Results.Following anal., the prevalence of seroreactivity was higher in patients with FM (22/47, 47%) compared to patients with OA (3/16, 19%) or RA (1/13, 8%) and the autoimmune disease control sera from poly/dermatomyosis (2/15, 13%), and patients with RA (3/30, 10%), SLE (1/30, 3%), and SSc (1/30, 3%).The prevalence of APA seroreactivity was also significantly higher in patients with severe FM (17/28, 61%) compared to patients with mild FM (11/37, 30%) and controls (4/21, 19%).In addition, both mean threshold and mean tolerance dolorimetry scores were significantly lower in the seropos. patients with mild FM (1.33, 1.95, resp.) compared to the seroneg. patients (1.83, 2.53; for both comparisons, resp.).Conclusion.These results reveal that an immunol. response, production of antipolymer antibodies, is associated with a subset of patients with FM.The results also suggest that the APA assay may be an objective marker in the diagnosis and assessment of FM and may provide addnl. avenues of investigation into the pathophysiol. processes involved in FM.

Autoimmune Technologies lnc.: The history of the firm.

Author: Wilson, R. B.

In 1995, Autoimmune Technologies was formed in New Orleans to license from Tulane University Medical Center the rights to a blood test that identified ill silicone breast implant patients After four years of research, discovery, publishing and expanding, the company now has the rights to patented or proprietary tests for newly-discovered antibodies and retroviral particles that are associated with more than a half-dozen common disorders, including fibromyalgia and lupus, the symptoms of which range from continuing nuisance through debilitating to fatal and which have in the past been very difficult to diagnose The company plans to commercialize the tests and to lead efforts to develop treatments and vaccines One key to the evolution of the company has been its relationship with Tulane, in whose labs these technologies were first discovered With that relationship continuing and growing, the company also plans to seek early-stage technologies from other institutions in Louisiana

100 Deals associated with Autoimmune Technologies LLC

100 Translational Medicine associated with Autoimmune Technologies LLC

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