MALVERN, Pa.--(BUSINESS WIRE)--XyloCor Therapeutics today announced it has successfully dosed the first two patients in the EXACT Trial, a Phase 1/2 dose escalation trial evaluating the safety, tolerability and efficacy of its lead candidate XC001 in patients with refractory angina. The trial will enroll patients who are not responding to medication and are unsuitable for coronary artery bypass graft or percutaneous coronary intervention. XC001 is an investigational novel gene therapy designed to activate naturally occurring biological pathways to improve blood flow to areas of the heart not receiving adequate blood supply. One patient was dosed at The Christ Hospital Health Network and a second at Minneapolis Heart Institute at Abbott Northwestern Hospital.
“People with refractory angina are forced to make many sacrifices in their lives as chest pain limits their ability to perform ordinary physical activities,” said Al Gianchetti, President and Chief Executive Officer of XyloCor Therapeutics. “Dosing the first patients in this clinical trial is an important milestone in XyloCor’s efforts to advance an innovative treatment that could reduce chest pain and enable people to resume the normal daily activities that improve their overall quality of life.”
“XC001 has the potential as a one-time gene therapy that will relieve chest pain by restoring blood flow to the heart,” said Rickey Reinhardt, MD, PhD, Chief Medical Officer of XyloCor Therapeutics. “The EXACT trial will provide us with vital data on the safety and efficacy of XC001 and we believe it will confirm evidence seen in previous pre-clinical and clinical programs with this mechanism of action.”
“Therapeutic treatments for refractory angina are limited and thus results in poor health including frequent angina with an extremely diminished quality of life. There is a tremendous need to explore gene therapy as a viable treatment option for advanced coronary artery disease, especially for patients who have exhausted all other medication and surgical options,” concluded Mr. Gianchetti.
About the EXACT Trial
The Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (EXACT) is a Phase 1/2 first-in-human, multicenter, open-label, single arm dose escalation trial evaluating the safety, tolerability and efficacy of XC001 at six months in patients who suffer from chronic angina caused by coronary artery disease with no other treatment options. The trial will enroll 12 patients (n=3 per cohort) who will receive one of four ascending intramyocardial doses of XC001, followed by an expansion cohort of 17 patients of the highest tolerated dose. Secondary endpoints at six months include efficacy measures of improvement in exercise capacity, reduction in angina episodes, improvement in coronary blood flow and improvement in quality of life.
More information about the EXACT trial is available at https://clinicaltrials.gov/ct2/show/NCT04125732.
XyloCor Therapeutics is a biopharmaceutical company focused on the development of novel gene therapy for unmet needs in advanced coronary artery disease. In the United States, coronary artery disease is a leading cause of death and disability. The Company’s lead product candidate, XC001, is in clinical development to investigate use for patients with refractory angina for which there are no treatment options. XyloCor also has a secondary product, XC002, in discovery stage, being developed for the treatment of patients with cardiac tissue damage from heart attacks. Co-founded by Ronald Crystal, MD, and Todd Rosengart, MD, XyloCor has an exclusive license agreement with Cornell University for the worldwide rights to develop, manufacture and commercialize XC001. For more information, visit www.xylocor.com.