EXACT 2
Research type
Research Study
Full title
Endocardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment: A 26-Week (with 26 Week Extension) Phase 2b Randomized, Multi-Center, Double-Blind, Sham Controlled Study to Evaluate Efficacy and Safety (The EXACT-2 Trial)
IRAS ID
1011559
Contact name
HJ Duckers
Contact email
Sponsor organisation
Xylocor Therapeutics Inc.
Eudract number
2024-514874-36
Clinicaltrials.gov Identifier
Research summary
In people with coronary artery disease (CAD) coronary arteries are narrowed due to fatty substances on their walls. Thus, the blood cannot flow freely through the arteries and the heart function is impaired. Significant number of patients with CAD have a refractory angina, long-term chest pain, which doesn’t get better despite the standard therapies. Refractory angina patients frequently experience chest pain; shortness of breath; pain that spreads to shoulders, arms, neck, jaw, stomach or back and easy tiredness. The condition is called "refractory" because the patient still experiences angina symptoms even after exhausting standard treatments.
The study medicine XC001 is a gene therapy that stimulates the heart to create new blood vessels to serve areas of the heart that are not receiving adequate blood supply. Due to newly created blood vessels the narrowed coronary arteries can be bypassed, and the blood can flow freely through the heart. The XC001 carries a gene, stimulating new blood vessel production - the so called vascular endothelial growth factor A (VEGF-A). The investigational product is injected directly into the heart with new investigational medical device called Extroducer® Infusion Catheter System.
The study will enroll patients with CAD, which have exhausted their conventional treatment options and those who do not have other therapeutic options.
The study has two parts. In the first part, 3 patients will be enrolled in the study. These patients will be checked to see if the study drug dose and the injection procedure are safe and work as expected. Both patients and doctors will know the treatment that is being given.
In the second part,106 patients will be enrolled. These patients will be randomly split - half of them will receive the study drug and the other 50% will have procedure mimicking drug injections but they will not be given any drug. The study doctor and the patient will not know whether the participant received XC001 or not.REC name
North East - York Research Ethics Committee
REC reference
25/NE/0175
Date of REC Opinion
13 Nov 2025
REC opinion
Further Information Favourable Opinion