EXACT‑2 Clinical Trial – Treatment for No Option Angina Patients
XyloCor is currently recruiting adults living with chronic angina to participate in the EXACT‑2 clinical trial to test XC001, an investigational gene therapy, that is delivered via cardiac catheter. This therapy is designed for “no option” refractory angina patients who suffer chronic symptoms and have exhausted all treatment options.
Have Questions About the Trial? Contact Us >>
EXACT‑2 Is Currently Enrolling Patients in US and UK
- EXACT‑2 is a multicenter, randomized, double‑blinded, sham controlled clinical trial that will evaluate the safety and effectiveness of XC001 in patients located in the United States, the UK and the EU. XC001 is designed to stimulate new blood vessel growth in the heart and aims to improve symptoms in patients living with chronic angina due to obstructive cardiovascular disease.
- The delivery of XC001 to the heart in the EXACT‑2 trial is performed in the cardiac catheterization lab (Cath Lab) by interventional cardiologists.
- Patient participation will last up to 14 months which will include screening visits, the study procedure visit and then five (5) follow‑up visits. Patients will also be followed in a long-term follow‑up study, which will consist of one telephone call annually.
EXACT‑2 Intended Patient Group
- Angina class II‑IV as measured by Canadian Cardiovascular Society (CCS)
- Ongoing chronic angina due to obstructive coronary artery disease (CAD), unsuitable for revascularization options
- Angina that remains symptomatic despite maximized medical therapy
Full inclusion and exclusion details for EXACT‑2 can be found here:
Study Details | NCT07048808 | Investigational Trial to Evaluate XC001 Delivered Via a Cardiac Catheter in Patients With Chronic Angina. | ClinicalTrials.gov
EXACT‑2 Trial Overview
| Study Title | Medical Condition(s) | Product |
|---|---|---|
| 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 | Refractory Angina (RA); Coronary Artery Disease (CAD) | AdVEGFXC1 (Ad5 Vector) |
| XyloCor Protocol Number | Number Of Subjects | Study Length |
| XC001-1002 | 106 | 14 months |
| ClinicalTrials.gov Identifier | ||
| NCT07048808 | ||
| Sex | Study Dates | Age |
| Male & Female | May 2025 - June 2027 | 18-85 |
| Phase | Study Center Locations | |
| 2b | US, UK and EU | |
EXACT‑2 Participating Sites
Additional Information About the EXACT‑2 Trial
Obstructive Coronary Artery Disease
Obstructive coronary artery disease is a chronic disease in which abnormalities that develop in the walls of arteries block the flow of blood to the heart. This inadequate cardiac blood flow is called “ischemia.” This causes what is known as ‘angina,’ a pain or pressure sensation that is felt in the chest.
Refractory Angina
Refractory angina cannot be controlled by standard medical treatments such as medications, coronary artery bypass surgery or coronary stenting.
You may qualify for the EXACT‑2 Trial if...
You are male or female between the ages of 18 and 85, and:
- You have been diagnosed with chronic angina and have been told you have no other treatment options.
- Your physician believes you are a good candidate for the trial.
- You meet certain eligibility requirements, and you agree to adhere to the required schedule of activities.
Is This Trial Right For Me?
If you think this trial is right for you or a loved one, please do the following:
- Discuss the study with friends, family and your primary care physician.
- Discuss the risks and potential benefits with your local study doctor and research staff.
- Request/obtain a copy of the informed consent form, which provides an in‑depth review of the trial. This is available upon request.
What You Can Expect as Part of the Trial
- Eligible participants should expect to undergo a catheter procedure that will last approximately 45 minutes.
- You will be assigned by chance (like flipping a coin) to either receive XC001 using an investigational catheter device, or a sham catheter with no administration of XC001.
- Participants will remain in the hospital for at least one overnight stay for observation, or longer if deemed necessary.
- Follow‑up assessments will be performed on Day 7 and on Weeks 4, 12, 26, and 52.
- You will be expected to undergo a PET scan as part of screening and study follow‑up.
- You will be expected to participate in an annual phone call as part of long‑term follow up.
Patient Travel
- Visits to the trial site are required for assessments and screening activities that will include, but are not limited to, physical exams, PET scans and treadmill tests.
- Participants may receive reimbursement for their time and reasonable travel‑related expenses.