LB-2 | VEGF Gene Therapy Improves Exercise Time, Ischemia, and Symptoms in Patients with Refractory Angina: Results of the Phase II EXACT Trial
Bibliographic record
Abstract
XC001 is a novel adenoviral-5 vector designed to express multiple isoforms of vascular endothelial growth factor to more safely and potently induce angiogenesis. The EXACT trial (NCT04125732) assessed the safety and preliminary efficacy of XC001 in patients with “no option” refractory angina (NORA). Single-arm, multicenter, open-label trial of 32 patients with NORA received a single treatment of XC001 (1×1011 viral particles) via transepicardial delivery. There were no SAEs attributed to study drug. Twenty expected SAEs in 13 patients were related to the surgical procedure. Total exercise duration (TED) increased from a mean±SD of 359.9±105.55 seconds at baseline to 448.2±168.45 (3 months), 449.2±175.9 (6 months), and 477.6±174.7 (12 months) (+88.3 [95% CI 37.1–139.5] and +84.5 [34.1–134.9], and +115.5 seconds [59.1-171.9] at 3, 6, and 12 months) (Fig. 1). Total myocardial perfusion deficit on positron emission tomography imaging decreased by 10.2% (95% CI -3.1–23.5%), 14.3% (2.8–25.7%), and 10.2% (-0.8-21.2%). Time to onset of ST depression during exercise tolerance testing increased by 105.2 (95% CI -27.9–238.3), 113.6 (28.8–198.4), and 103.1 seconds (26.7–179.5). Angina frequency decreased by -7.7 (95% CI 4.1–11.3), -6.6 (3.5–9.7), and -8.8 episodes (4.6–13.0). Angina class improved in 81% of participants at 6 months. XC001 administered via transepicardial delivery is safe and generally well-tolerated in NORA. Exploratory improvements in exercise duration, ischemic burden, and angina frequency and severity support a biologic effect sustained to 12 months, warranting further investigation.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.049 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".