Presented by: Emmanuel E. Egom, MSc, MD, PhD, MRCP (UK) At the Academy of Applied Pharmaceutical Sciences (AAPS) in Toronto, Canada 12/19/2014

1. PLASMONIC NANOPHOTOTHERMIC THERAPY OF
ATHEROSCLEROSIS (NANOM FIM,
NCT01270139)
Presented by:
Emmanuel E. Egom, MSc, MD, PhD, MRCP (UK)
At the Academy of Applied Pharmaceutical Sciences (AAPS) in Toronto
12/19/2014

2. OVERVIEW
 Background
 Hypothesize
 Study Design
 Results
 Conclusion

3. BACKGROUND
 Cardiovascular disease is one of the main cause of disability and
death worldwide.
 The underlying cause generally is atherosclerosis.
 Some modern angioplasty techniques generally just manipulate the
form of the plaque and have some clinical and technical restrictions,
relatively high complication rate and restenosis risk.

4.  Prevention of atherosclerosis and treatment of its complications
remain a clinical challenge (risk factor modification or systemic drug
therapy e.g. statin).
 The reversal of atherogenesis becomes a new more attractive target
for the progress of cardiovascular therapy, and coronary device
development

5.  Numerous devices utilizing heat and high-energy light such as laser
technology, radio frequency sparking have been recently described
as the applications to treat atheroma.
 Plasmonic photothermal therapy (PPTT) is the novel invasive
approach in cardiology
 Treatment with PPTT may induce plaque burden reduction up to 79.4
mm3 (up to 6.38 mm3 with Statins)

6. HYPOTHESIZE
 Nanoburning may demolish and reverse the plaque especially
in combination with stem cell technologies with promising
functional restoration of the vessel wall.
 First-in-man nanotechnology trial assessing potent clinical
opportunities, efficacy and safety of such novel technique for
angioplasty as plasmonic atherodestruction.

7. STUDY DESIGN
 Allocation: Randomized in a 1:1:1 ratio
 Endpoint Classification: Safety/Efficacy Study
 Intervention Model: Parallel Assignment
 Masking: Double Blind (Subject, Investigator)
 Primary Purpose: Treatment

8. RECRUITMENT INFORMATION
 Recruitment Status: Completed
 Enrollment: 180
 Completion Date: June 2012
 Eligibility Criteria:
Inclusion Criteria: age 45-65 years old, male and female with single-
or multi-vessel CAD with flow-limiting lesions
Exclusion Criteria: non-compliance, history of myocardial infarction,
unstable anginaor other disrhythmias, stroke.
 Location Countries: Russian Federation

9. INTERVENTION
 (1) nano-intervention with delivery of silica-gold NP in mini-
surgery implanted bioengineered on-artery patch (n=60)
 (2) nano-intervention with delivery of silica-gold iron-bearing
NP with targeted micro-bubbles or stem cells in hands of
magnetic navigation system (n=60)
 (3) stent implantation (n=60)

10. STUDY ARM (S)
 Experimental: Nano group 60 patients undergoing
transplantation of nanoparticles
 Active Comparator: Ferro group 60 patients in undergoing
intracoronary infusion of allogenious stem cells or CD68
targeted micro-bubbles pre-cultivated in the medium with iron-
bearing nanoparticles

11. RESULTS
 The mean TAV reduction at 12 months in Nano group was 60.3 mm3
(p<0.05).
 The reduction of the PAV (per cent atheroma volume) post-
procedure/ at 12-month follow-up was 12.6/44.8%, 13.1/ 43.2%,
20.2/ 22.7% (p<0.05) in groups respectively.

12.  The increase of minimal lumen diameter from baseline to post-
procedure/ at 12-month follow-up was 5.9/ 63.6%, 21.2/ 63.8%, 56.2/
62.4% (p<0.05) in groups respectively.
 The analysis of the event free survival of the ongoing clinical follow-
up shows the significantly lower risk of cardiovascular death in Nano
group if compare with others (91.7% vs 81.7% and 80% respectively;
p<0.05).

13. CONCLUSION
 Atherodestruction in hands of plasmonic resonance of the
silica-gold NP resulted in significant regression of coronary
atherosclerosis.

14. Thank you
Any questions?