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    Summary
    EudraCT Number:2004-001250-91
    Sponsor's Protocol Code Number:GV-002.001
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-07-18
    Trial 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2004-001250-91
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of BIOBYPASS® (ADGVVEGF121.10NH) Delivered by NOGA-Guided/MYOSTAR Catheter in "No Option" Patients with Class II-IV Stable Angina
    A.3.2Name or abbreviated title of the trial where available
    NOVA Trial
    A.4.1Sponsor's protocol code numberGV-002.001
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGenVec, 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 nameBIOBYPASS
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntracardiac use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameAdGVVEGF121.10NH
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.67e10 pu/mL
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntracardiac use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to severe angina pectoris due to advanced coronary artery disease (CAD).
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of intramyocardial delivery of BIOBYPASS® (4xe10 pu) on exercise tolerance in participants with advanced CAD and angina pectoris at 26 weeks post-dosing, as determined by change from baseline in total exercise duration on exercise tolerance testing, compared to placebo.
    E.2.2Secondary objectives of the trial
    To further assess the activity of BIOBYPASS® compared to placebo as estimated by exercise tolerance at 12 and 52 weeks, time to onset of 1mm additional ST-segment depression at 12, 26, and 52 weeks, and SPECT perfusion studies (using pharmacological stress) at 26 weeks post-dosing.

    To assess the safety and tolerability of intramyocardial administration of BIOBYPASS® in participants with advanced CAD and moderate to severe angina pectoris.

    Various additional functional and objective parameters (time to level 2 angina, peak rate-pressure product, and maximum workload on ETT, QOL, angina class, angina attacks and nitroglycerine consumption) will also be evaluated at 12, 26 and 52 weeks post-dosing.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    · Age greater than or equal to 18 years and less than or equal to 80 years;

    · Written informed consent obtained prior to any study dictated procedure;

    · Moderate to severe angina (CCS Angina Class II-IV) despite optimal medical therapy;

    · Treated with optimal unchanged antianginal medical therapy for at least 2 months prior to the first baseline ETT. Optimal medical therapy must include the following medications (unless hemodynamic parameters or intolerance contraindicate their use):
    - Nitroglycerine;
    - Antianginal medications: Long-acting nitrates, calcium-channel blockers, potassium channel opener and beta-blockers (Note: All participants are required to be on at least 2 of the 4 antianginal medications listed above); and
    - Platelet aggregation inhibitor (e.g., aspirin, ticlopidine, or clopidogrel).

    · The participant must have, within 3 months prior to randomization, documented coronary angiographic evidence of significant 2- or 3- vessel disease, or equivalent disease in one dominant artery, and at least one remaining larger coronary vessel from which new collaterals/vessels could be supplied.

    · Any participant who has undergone CABG or PCI within 6 months of entry must have angiography performed within 1 month prior to entry, and at least 4 months after the previous intervention to rule out early restenosis.

    · Candidates must not be eligible for any other re-vascularization procedures. The participant and his coronary film must have been discussed with an independent cardiac surgeon and must have been denied for CABG or PTCA. Participants who are marginal or poor candidates for conventional revascularization will be considered eligible if the risks of performing a CABG or PTCA procedure outweigh the potential benefit and/or such a procedure is unlikely to offer a worthwhile clinical benefit. The criteria defining such cases may include, but may not be limited to, the following examples:
    - Diffuse or distal vessel disease
    - Chronic occlusions
    - Unprotected left main stenosis
    - Tortuous or severely angulated vessels
    - Severely calcified vessels
    - Small vessels (< 2.5mm)

    · Two baseline bicycle ergometry exercise tolerance tests (ETTs) performed meeting the following criteria:
    - Able to exercise for a minimum duration of 2 minutes and no more than 10 minutes
    - Exercise duration on the two ETTs must be within 15% of each other. (The second test will be used for the baseline value. In the event of excessive variability, a third test may be performed and the participant may be enrolled if exercise duration on the third test is within 15% of either prior test. In this case, the third test will be used as the baseline value.)
    - ETTs must not be discontinued for any reason other than ETT Angina Level 3
    - Note: Participant must NOT be informed of exercise restrictions required for entry.

    · Significant reversible myocardial ischemia on a single photon emission computer tomography (SPECT). Judgment will be made by an independent core lab. The size of the reversible defect must be > 10 % of left ventricle.

    · Ventricular wall thickness of the treatment zone > 8mm as per baseline echocardiogram.
    E.4Principal exclusion criteria
    · Pregnant or lactating women. It is required that both men and women use condoms or another barrier method of birth control for at least 8 weeks following administration of BIOBYPASSÒ and some form of birth control for at least one year;

    · Clinically significant anemia (e.g. hematocrit < 36% or hemoglobin < 12 g/dL for men and < 11 g/dL for women), leukopenia (WBC<3,000/mL), leukocytosis (WBC > 12,000), or thrombocytopenia (platelet count < 100,000 billion/l);

    · Abnormal prothrombin or partial thromboplastin time or anticoagulant therapy that cannot be withheld for treatment;

    · Significant renal dysfunction (serum creatinine > 1.6 mg/dL);

    · Hepatic dysfunction (AST/ALT must be within normal limits);

    · Hematuria, unless of known, non-malignant etiology

    · Uncontrolled hypertension (systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg) or significant hypotension (systolic blood pressure <90 mmHg);

    · Conditions other than angina that will limit exercise test (e.g. severe peripheral vascular disease, COPD);

    · Ophthalmologic conditions pertinent to proliferative retinopathy Conditions that preclude standard ophthalmologic examination.
    - Cataract surgery within 6 months of trial;
    - Vascular lesions of the anterior segment of the eye (infection or ulceration of the cornea, rubeotic glaucoma, etc);
    - Vascular lesions of the posterior segment of the eye or proliferative retinopathy in diabetics, macular edema, s/p photocoagulation for macular edema or proliferative retinopathy; nondiabetics with central or branch retinal vascular occlusions, sickle cell retinopathy, ischemic retinopathy due to retinal venous stasis or carotid artery disease);
    - Choroidal new vessels associated with age-related macular degeneration, myopic degeneration, presumed ocular histoplasmosis syndrome, angioid streaks, pseudoxanthoma elasticum, or without ocular disease; and
    - Large elevated choroidal nevi, choroidal vascular tumors (choroidal hemangioma), or melanomas.

    · Any acute illness within one week of the start of the study or any other illness considered by the Investigator to significantly interfere with study outcome;

    · Clinical evidence of active infection of any type, including adenovirus; (Paul – did you want ad-neutralizing antibody titer included?)

    · Immunocompromised status (in the investigator’s opinion) or currently receiving immunosuppressive therapy;

    · Left ventricular ejection fraction < 25% as measured by LV angiography.

    · Congestive heart failure NYHA class III-IV;

    · Valvular heart disease requiring surgical intervention or hemodynamically significant aortic valve disease;

    · Recent (less than 6 weeks prior to screening) Acute Coronary Syndrome with increase in CK-MB or Troponins/PCI/CABG/Stroke or TIA;

    · History of malignancy (except cured non-melanoma skin cancer) or suspicion of current malignancy;

    · Known allergy to the diluent used to suspend the virus;

    · Other experimental medications within the last four weeks prior to the second baseline ETT;

    · Revascularization procedure (percutaneous coronary intervention or coronary artery bypass) within 4 months of Day 1.

    · Participants who have previously received VEGF or any other angiogenic agent or gene therapy in the past, or who have participated in other investigational studies within the last year if the endpoints are overlapping.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline at week 26 in total exercise duration on exercise tolerance test (bicycle ergometry protocol).
    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 No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    The study will be complete for final analysis when the last participant has completed his/her Week 52 Visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 109
    F.4.2.2In the whole clinical trial 129
    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)
    Participants who are alive and not lost to follow-up at the time of discontinuation from, or completion of, the study-specified 52-week follow-up period or cross-over follow-up will be automatically entered into GenVec’s general continuation protocol, and will be contacted annually.
    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 Decision2005-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
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