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    Summary
    EudraCT Number:2021-002803-37
    Sponsor's Protocol Code Number:XC001-1001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-09-22
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2021-002803-37
    A.3Full title of the trial
    A Phase 1/2 Trial of Direct Administration of AdVEGF-All6A+, a Replication Deficient Adenovirus Vector Expressing a cDNA/Genomic Hybrid of Human Vascular Endothelial Growth Factor, to the Ischemic Myocardium of Subjects with Angina Pectoris Secondary to Coronary Artery Disease that is Refractory to Drug Therapy and Unsuitable for Revascularization
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (The EXACT Trial): A Phase 1/2 Multi-Center, Open-Label Study to Evaluate Safety, Tolerability and Efficacy
    A.4.1Sponsor's protocol code numberXC001-1001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorXyloCor Therapeutics, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportXyloCor Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationXyloCor Therapeutics, Inc.
    B.5.2Functional name of contact pointgeneral information
    B.5.3 Address:
    B.5.3.1Street Address39 Addison Lane
    B.5.3.2Town/ cityMalvern
    B.5.3.3Post codePA 19355
    B.5.3.4CountryUnited States
    B.5.4Telephone number888-290-0081
    B.5.6E-mailinfo@xylocor.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameXC001
    D.3.4Pharmaceutical form Solution for injection in vial
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracardiac use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAdVEGFXC1
    D.3.9.3Other descriptive namea modified adenovirus serotype 5 vector expressing multiple isoforms of human vascular endothelial growth factor
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number183000000000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Angina Pectoris Secondary
    E.1.1.1Medical condition in easily understood language
    Angina Pectoris Secondary
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10002383
    E.1.2Term Angina pectoris
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and tolerability of XC001 through 6 months following a one-time epicardial administration to subjects who have refractory angina.
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and tolerability of XC001 through 12 months.
    - To evaluate the effect of XC001 on myocardial ischemia as manifested by exercise tolerance, myocardial perfusion, angina pectoris and physical activity.
    - To evaluate the effect of XC001 on quality of life (QOL).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females, age 18 to 75 years, inclusive, at the time of signing informed consent form for the 4 dose escalation phase and age 18 to 80 years, inclusive, for the expansion phase at the highest tolerated dose.
    2. Diagnosis of chronic angina due to obstructive coronary artery disease (CAD) that is refractory to drug therapy and unsuitable for revascularization via coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) as confirmed by the ERC.
    3. History of evidence of reversible left ventricular ischemia, as assessed by stress electrocardiography (ECG including screening), stress echocardiography, single-photon emission computed tomography (SPECT), PET (including screening) or cardiac magnetic resonance (CMR) imaging that has not resolved with intervention or by an acute coronary event.
    4. Coronary angiography within the past 12 months unless there is a clinical indication from the subject’s medical history or screening tests to warrant a more current procedure as determined by the investigator and/or ERC.
    5. Two ECG stress tests that adhere to the following (details outlined in the ETT manual):
    a. A modified Bruce protocol that includes two three-minute warm-up stages of 1.7mph/0% grade and 1.7mph/5% grade must be used;
    b. Total exercise duration of 90 seconds to approximately 9 minutes that is limited by angina.
    c. Total exercise duration of the shorter test must be within 25% of the longer test and the difference between the two tests cannot exceed 75 seconds;
    d. At least one of the two tests must demonstrate ≥ 1 mm horizontal or down-sloping ST segment depression as compared to baseline, while the other test must demonstrate ≥ 0.5 mm horizontal or down-sloping ST segment depression. This will not be a requirement for subjects in cohorts 1, 2 and 3 while some subjects in cohort 4 and the highest tolerated dose expansion may have to meet this requirement;
    e. The tests must be performed at least 72 or more hours apart from each other. A third test is permitted if the second test does not meet the criteria. (NB: The ETT core laboratory must review and approve the ETTs for eligibility.)
    6. Angina class II - IV as measured by the CCS Functional Classification of Angina Pectoris.
    7. On a stable regimen of anti-anginal, anti-hypertensive, and lipid lowering medications deemed medically appropriate for refractory angina at the discretion of the investigator. The chronic anti-anginal regimen must include at least two functional classes at the maximally tolerated dose for the preceding 30 days prior to the screening visit. Functional classes include beta-blockers, calcium channel blockers, nitrates and metabolic modulators (i.e., ranolazine).
    8. Formally cleared by the ERC to undergo the gene therapy procedure by a review of past medical history and screening assessments, with emphasis on reversible left ventricular ischemia (further details provided in the ERC Charter).
    9. Anti-adenovirus serotype 5 neutralizing antibody titer < 1:320.
    10. Adequate hematologic function defined as hemoglobin ≥ 10 g/dL, absolute neutrophil count > 1.2 × 103 per μL and platelet count ≥ 75,000 per μL.
    11. Adequate hepatic function defined as alanine aminotransferase and aspartate aminotransferase ≤ 3 x ULN and total bilirubin ≤ 2 x ULN unless the subject has a previously known history of Gilbert’s syndrome.
    12. Adequate renal function defined as the estimated glomerular filtration rate (eGFR) > 60 mL/minute/1.73 m2 by the Modification of Diet in Renal Disease (MDRD) formula in the 4 dose escalation phase and eGFR > 29 mL/minute/1.73 m2 in the highest tolerated dose expansion phase, and no current or likely need for hemodialysis in the next 12 months (a retest is permitted if the first test does not meet the criteria and if it meets the inclusion, this test will be used as baseline).
    13. All male subjects or male partners, regardless of fertility status or the fertility status of their partner, must agree to use a condom and spermicide during any sexual relations for 2 months following administration of investigational product to protect their partner from potential viral shedding.
    14. All subjects capable of procreation with their partners must agree to use adequate contraception for 2 months following administration of investigational product to avoid pregnancy. Adequate contraception is defined as oral or injectable contraceptives, intrauterine devices, surgical sterilization in addition to/or a combination of a condom and spermicide.
    15. Agree to not donate sperm or oocytes for 2 months following administration of investigational produkt
    16. Capable of providing informed consent and undergoing all the required tests and procedures in the protocol.
    E.4Principal exclusion criteria
    1. Any of the following:
    a. ST elevation myocardial infarction (STEMI) or non-ST elevation myocardial infarction (NSTEMI) not requiring revascularization, transmural myocardial infarction or cerebral vascular accident within the past 30 days prior to the screening visit;
    b. Current hypercholesterolemia defined as low-density lipoprotein (LDL) above 190 mg/dL;
    c. Sustained, current systolic blood pressure less than 90 mmHg or uncontrolled hypertension (systolic blood pressure [BP] >180 mmHg, diastolic BP >100 mmHg) despite maximal medical treatment;
    d. Current electrocardiographic abnormalities that would interfere with ST-segment analysis, such as the presence of a pacemaker, complete Left Bundle Branch Block (LBBB), Left Ventricular Hypertrophy (LVH) with repolarization abnormalities, Wolff-Parkinson-White Syndrome (WPW), or marked resting repolarization abnormalities (eg ST segment depression > 1.5 mm). This electrocardiographic requirement may apply to some subjects in dose escalation cohort 4, as well as some subjects in the highest tolerated dose expansion phase but will not be a requirement for subjects in dose escalation cohorts 1, 2 and 3.
    e. Current untreated malignant ventricular arrhythmia;
    f. Current untreated bradyarrhythmia for which an artificial pacemaker is indicated;
    g. Congestive heart failure defined as New York Heart Association Function Class III or IV or left ventricular ejection fraction < 25% within the 6 weeks prior to the screening visit (or as assessed by the screening Echo);
    h. History of or planned cardiac transplantation (the possibility of an exception can be discussed with the XyloCor medical monitor if the subject is unlikely to undergo a transplant during the duration of the trial due to ranking); and/or
    i. Current mitral or aortic valvular heart disease requiring mechanical intervention.
    2. Body mass index that would interfere with any of the protocol-required tests and procedures, including investigational drug administration.
    3. Diabetic individuals with active proliferative diabetic retinopathy or glycosylated hemoglobin (HbA1c) > 8.5% (a retest is permitted if the first test does not meet the criteria and if it meets the inclusion, this test will be used as baseline).
    4. A history or evidence of human immunodeficiency virus (HIV) on screening or active hepatitis C virus (HCV), active hepatitis B virus (HBV) or active COVID-19 infection on screening. COVID-19 infection requiring hospitalization (or release from the hospital) within the past 90 days prior to the screening visit.
    5. Chronic oral corticosteroid therapy or therapy with other immunosuppressive medications.
    6. Diagnosis of, or treatment for, any cancer within the last 5 years except for basal or squamous cell carcinoma or carcinomas in situ where surgical excision was considered curative. (Past medical history of cancer is not exclusionary as long as the subject has been disease free for at least 5 years since the time of diagnosis and treatment).
    7. Known hypersensitivity or any other contraindication to adenosine or regadenoson, formulation buffer used to suspend the viral vector or contrast agents used in any of the radiographic procedures or contraindication to general anesthesia.
    8. Hypersensitivity to amide-containing agents which are used for control of post-administration pain through an intercostal nerve block.
    9. Pregnancy or currently lactating.
    10. Receiving an investigational intervention or participating in another clinical trial within 30 days or within 5 half-lives of the drug prior to screening. Exception may be made if the individual is enrolled in a non-therapeutic observational study (registry) or the observational portion of a therapeutic study where the sponsoring authority authorizes enrollment.
    11. Prior participation in any gene therapy; however, if the study was unblinded or documentation otherwise exists that the subject was randomized to the placebo control group and did not receive active gene transfer agent, the subject may be considered for this study.
    12. Has a serious or unstable medical or psychological condition (including drug or alcohol abuse) that, in the opinion of the investigator, would compromise the subject’s safety or successful participation in the study or interpretation of study results.
    E.5 End points
    E.5.1Primary end point(s)
    Safety through Month 6: AEs and SAEs
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety parameters will be collected at the 6 month visits to assess safety through month 6: AEs and SAEs
    E.5.2Secondary end point(s)
    - Change from baseline to Month 6 in time to 1 mm ST segment depression during exercise tolerance test (ETT) as assessed by a blinded core laboratory
    • Change from baseline to Month 6 in total exercise duration during the Modified Bruce protocol ETT
    • Change from baseline to Month 6 in time to angina during ETT
    • Change from baseline to Month 6 in Seattle Angina Questionnaire (SAQ) score
    • Change from baseline to Month 6 in angina class as measured by the Canadian Cardiovascular Society (CCS) Functional Classification of Angina Pectoris
    • Change from baseline to Month 6 in the frequency of angina episodes, severity of angina episodes and amount of exertion causing angina episode
    E.5.2.1Timepoint(s) of evaluation of this end point
    These will be evaluated at the 6 month visit.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    not applicable
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Russian Federation
    United States
    Italy
    Netherlands
    Poland
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 44
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-13
    P. End of Trial
    P.End of Trial StatusCompleted
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