XyloCor Therapeutics has commenced the Phase II part of the Phase I/II EXACT clinical trial assessing its gene therapy candidate, XC001 (encoberminogene rezmadenovec), for refractory angina patients with no other therapy options.
The Phase I dose‑escalation part of the trial is complete and its data was reviewed by the Independent Data Monitoring Committee (IDMC).
Based on the review findings, the IDMC permitted the company to advance to the Phase II part with the highest dose assessed.
Following the authorisation, three patients received dosing in the Phase II expansion cohort. The safety and efficacy data from this part are expected to be reported next year.
XyloCor Therapeutics president and CEO Al Gianchetti said: “In our mission to deliver safe and effective gene therapies that transform the lives of people with cardiovascular disease, we are excited to achieve this important milestone and advance into the Phase II portion of our study.
“XC001 has enormous potential to significantly improve the lives of patients with refractory angina.”
XC001 is developed to induce new blood vessels creation in the heart for evading diseased vessels and restoring coronary blood flow.
The drug carries the gene for a vascular endothelial growth factor (VEGF) to the target myocardial cells, in turn triggering the growth of fresh blood vessels through the angiogenesis process.
It has a fast track designation from the US Food and Drug Administration (FDA) for refractory angina.
Initiated last year in the US, the multi-centre, open‑label, single‑arm, dose‑escalation EXACT trial enrolled 12 refractory angina patients into four ascending dose arms in the Phase I part.
The Phase II part will involve 21 more patients to evaluate the highest tolerated XC001 dose.
XC001 will be given directly to the heart muscle in a mini‑thoracotomy by a cardiac surgeon.
XyloCor is also planning to apply to the FDA for another Phase II trial of XC001 as adjunctive treatment to coronary artery bypass grafting (CABG) in the coming months.
The company intends to carry out additional studies on other cardiovascular diseases.