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Clinical Trial Report
Gene Therapy Trial Report
Summary
Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (The EXACT Trial)
NCTID
NCT04125732
(View at clinicaltrials.gov)
Description
The primary purpose of this trial is to determine the safety of XC001 (AdVEGFXC1) in patients who suffer from angina caused by coronary artery disease and have no other treatment options. Subjects in this study will receive one of four intramyocardial doses of XC001 that expresses human vascular endothelial growth factor (VEGF) which induces therapeutic angiogenesis (revascularization).
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Development Status
Active
Indication
Coronary Artery Disease, Ischemia, Angina Refractory, Cardiovascular Diseases, Heart Diseases
Disease Ontology Term
DOID:114
Compound Name
XC001
Compound Alias
Encoberminogene rezmadenovec
Sponsor
XyloCor Therapeutics, Inc.
Funder Type
Industry
Recruitment Status
Completed
Enrollment Count
41
Results Posted
Not Available
Therapy Information
Target Gene/Variant
VEGF
Therapy Type
Gene transfer
Therapy Route
In-vivo
Mechanism of Action
Overexpression of protective allele/gene
Route of Administration
Intramyocardial
Drug Product Type
Viral vector
Target Tissue/Cell
Delivery System
Viral transduction
Vector Type
Ad5
Editor Type
none
Dose 1
1E9 vp
Dose 2
1E10 vp
Dose 3
4E10 vp
Dose 4
1E11 vp (Expansion Dose)
Dose 5
Study Record Dates
Current Stage
Phase1, Phase2
Submit Date
2019-10-04
Completion Date
2023-05-30
Last Update
2024-01-30
Participation Criteria
Eligible Age
18 Years - 80 Years
Standard Ages
Adult, Older adult
Sexes Eligible for Study
ALL
Locations
No.of Trial Sites
16
Locations
United States
Regulatory Information
Has US IND
True
FDA Designations
Recent Updates
Resources/Links
Clinical Publications
Angiogenic Gene Therapy for Refractory Angina: Results of the EXACT Phase 2 Trial
EXACT Trial: Results of the Phase 1 Dose-Escalation Study
News and Press Releases
https://www.xylocor.com/news.html
Preclinical Publications
Safety and biodistribution of XC001 (encoberminogene rezmadenovec) gene therapy in rats: a potential therapy for cardiovascular diseases
Alteration of splicing signals in a genomic/cDNA hybrid VEGF gene to modify the ratio of expressed VEGF isoforms enhances safety of angiogenic gene therapy
Safety of direct cardiac administration of AdVEGF-All6A+, a replication-deficient adenovirus vector cDNA/genomic hybrid expressing all three major isoforms of human vascular endothelial growth factor, to the ischemic myocardium of rats
Adenovirus-mediated transfer of a minigene expressing multiple isoforms of VEGF is more effective at inducing angiogenesis than comparable vectors expressing individual VEGF cDNAs
Protocol
Epicardial delivery of XC001 gene therapy for refractory angina coronary treatment (The EXACT Trial): Rationale, design, and clinical considerations