XyloCor Therapeutics
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. Our lead product candidate, XC001, is in clinical development for patients with refractory angina for which there are no treatment options. XyloCor also has a secondary product, XC002, in discovery stage, for patients with cardiac tissue damage from heart attacks.
Company details
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- Business Type:
- Manufacturer
- Industry Type:
- Pharmaceuticals
- Market Focus:
- Nationally (across the country)
Our Vision
Improve the lives of people who struggle with daily activities due to cardiovascular disease through our commitment to advancing the science of gene therapy.
History
XyloCor founders Dr. Ronald Crystal and Dr. Todd Rosengart started their collaboration in the 1990s at Weill Cornell Medical College where they combined their expertise in gene therapy and cardiac surgery to develop potential treatments for patients with advanced coronary artery disease. Their work continues to be referenced by the scientific community and is the foundation for the creation of XyloCor and its clinical programs. XyloCor holds exclusive license from Weill Cornell Medical College for the gene therapy being developed by the company.
Our Approach
Coronary artery disease (CAD), characterized by blood flow-limiting atherosclerotic lesions in the epicardial coronary vasculature, causes inadequate cardiac blood flow (myocardial ischemia) and consequent symptoms of chest pain (angina), dizziness and/or fatigue, which occur when the heart is not receiving an adequate blood supply. Aside from the mortality risk associated with this restriction in blood flow — either acutely because of myocardial infarction, or chronically because of heart failure — CAD symptoms can severely impair the quality of life and the functional capabilities of individuals with advanced disease. Unfortunately, genetic heterogeneity in the human population leads to an inadequate natural collateralization response in many, as reflected in the number of individuals with persistent ischemia resulting from CAD.
Based on knowledge garnered over the past several decades, we have developed our lead gene therapy candidate, XC001, as a vehicle to stimulate and augment the native tissue revascularization mechanisms specifically targeting individuals who have demonstrated an inadequate endogenous self-revascularization response to ischemia. By building upon these naturally occurring biologic pathways, we have been able to demonstrate that XC001 and its prototype formulations are capable of robustly enhancing the blood supply to ischemic tissues in animal models and in clinical testing.
XyloCor holds exclusive license from Weill Cornell Medical College for the gene therapy being developed by the company.
Angina Treatment Trial
About the EXACT Trial for Refractory Angina Patients
The EXACT clinical trial is a Phase 1/2 multicenter, open-label, single arm, dose escalation trial. Approximately 12 subjects (N=3 per cohort) who have refractory angina will be enrolled into 4 ascending dose groups, followed by an expansion of the highest tolerated dose with 21 additional subjects.
The trial is designed to test the safety and tolerability of an investigational product called XC001. This is the first research study in which this drug will be administered to humans. The study drug is designed to promote new blood vessels in the heart, with these new blood vessels bypassing diseased blood vessels and improving blood flow in the heart.
The study drug is designed to deliver a gene that allows targeted heart cells to create more of a protein that already naturally exists. This process is called gene transfer. The study drug aims to deliver the gene to cells via an injection to the heart. This will be done during a one-time administration of the investigational product XC001 directly to the muscle tissue of the heart by an experienced surgeon.
Participation includes 9 clinic visits during the first 6 months and then a final visit 1 year after receiving the study drug for a total duration of approximately 13 months.
How Does Gene Therapy Work in This Trial?
The gene therapy product XC001 is an altered adenovirus, referred to as the vector, that includes a gene for human vascular endothelial growth factor or VEGF. The vector cannot reproduce and has been shown to be safe in human studies.
- Once the vector is delivered to the heart and makes its way into cells, it breaks up while delivering the gene into the cell nucleus, where DNA is located.
- Your own cell machinery makes VEGF protein and then ships it outside the cell where the protein can help new blood vessels form.
- This is expected to bring more blood and oxygen to areas of the heart that need it.