Abstract 5767: Viral Anti-inflammatory Treatment of Unstable Coronary Syndromes: The VT-111 Acute Coronary Syndrome Trial
Bibliographic record
Abstract
Background: Up-regulation of inflammatory responses contributes to coronary plaque rupture, thrombosis, and vascular occlusion leading to myocardial and cerebral infarction. Some viruses have developed potent proteins that block key steps in both the innate and adaptive immune responses. VT-111 is a viral serine proteinase inhibitor that demonstrates reductions in monocyte migration to sites of vascular damage in a wide range of animal models. Methods: In a double-blind, placebo-controlled trial, the safety of VT-111 plus standard of care was evaluated in patients with acute coronary syndromes treated with stents. Patients received IV VT-111 or placebo once daily for 3 days, starting immediately before intervention. Patients were followed for 3 days in hospital, and at 14, 28 days and 3 and 6 months for safety/efficacy endpoints, including biomarker analysis and MACE (death, MI or revascularization). At 6 months, restenosis was evaluated by intravascular ultrasound. Results: Forty-eight patients were enrolled at 7 sites; 19 patients received 5 μ g/kg VT-111, 17 patients received 15 μ g/kg and 12 patients received placebo. There were no differences between the treated and control groups on key safety endpoints, including coagulation parameters and adverse events. A trend towards a decrease in MACE was observed, with a reduction to 0% in the 15 μ g/kg group from 18% in controls. A significant, dose-dependent reduction in Troponin I levels was observed with VT-111 at 8, 16, 24 and 54 hours post-dose (p<0.05). Similar reductions were observed in CK-MB levels at 8, 16 and 24 hours post-dose (p<0.05). Trends towards a reduction in MCP-1 were also observed. Further analysis suggests that VT-111 may also have early effects on markers such as EN-RAGE (S100A12), IL-6 and CD40L. There were no differences in in-stent plaque area or lumen area between control and treated groups, as assessed by IVUS. Conclusion: This randomized, placebo-controlled trial supports the safety of 3 daily IV injections of VT-111, a first in class viral-derived anti-inflammatory therapeutic agent. A significant reduction in biomarkers of cardiac damage demonstrates the potential of this novel class of protein therapeutics.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".