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.
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.
Independent Data Monitoring Committee authorized proceeding to Phase 2 at highest dose level tested following review of clinical safety data from the Phase 1 dose escalation
Phase 2 clinical data readouts on safety and efficacy of XC001 anticipated in 2022
Company plans to commence study startup of XC001 as an adjunct to CABG in 2H21, and clinical studies in additional cardiovascular indications are under discussion
Progress highlights potential of gene therapy in cardiovascular disease
Positive Phase 1 results reported at the American Association for Thoracic Surgery (AATS) and the American Society of Gene and Cell Therapy (ASGCT) revealed XC001 is well tolerated at all dose levels
Phase I data support XC001 therapeutic effect and potential dose response
Topline Phase 2 data readout expected in February 2023 with interim results in the second half of this year
XyloCor Therapeutics, a clinical-stage biopharmaceutical company developing novel gene therapies for cardiovascular disease,...
Data from the Phase 1 dose-escalation portion of the Phase 1/2 EXACT study demonstrate XC001 was well-tolerated at all dose levels tested; highest dose level evaluated selected for ongoing Phase 2 portion of the study –
Preliminary efficacy data highlight XC001 potential for patients with refractory angina with no other treatment options –
Treatment strategy is to use local administration to achieve higher gene expression in the heart while minimizing systemic vector circulation and associated side...
Elizabeth Tarka, M.D. appointed Chief Medical Officer
A. Brian Davis named Chief Financial Officer
XyloCor Therapeutics, a clinical-stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today announced that it has appointed Elizabeth Tarka, M.D. as Chief Medical Officer and A. Brian Davis as Chief Financial Officer. These experienced pharmaceutical industry executives will enhance the company’s clinical development, operational, and financial capabilities and drive...
Company closes additional $22.6 million in new financing
Proceeds will fund initiation of new clinical trial for lead gene therapy candidate XC001 as adjunctive therapy for patients undergoing coronary artery bypass graft surgery
XyloCor Therapeutics, a private clinical-stage biopharmaceutical company focused on the development of gene therapy for the significant unmet patient needs in advanced coronary artery disease, today announced the closing of an additional $22.6 million financing. Fountain Healthcare...
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...
XyloCor Therapeutics, a private clinical-stage biopharmaceutical company focused on the development of gene therapy for unmet needs in cardiovascular disease, strengthens its leadership team with the appointment of Alexander Gaidamaka, PhD, as Senior Vice President of Technology, Manufacturing & Quality. Dr. Gaidamaka brings a wealth of product development, regulatory and manufacturing experience across multiple technology platforms and GMP quality design and operations from his tenures with Sanofi Group,...
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