CYTX Conference on Cell Therapy for Cardiovascular Disease
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Transcript of CYTX Conference on Cell Therapy for Cardiovascular Disease
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Cytori Therapeutics7th International Conference on Cell Therapy for Cardiovascular Disease
Focus on Acute Injury Technologies
25 January 2012
Alex Milstein, M.D.
VP, Clinical Development
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Real-Time Access to Autologous Regenerative Cells
Cardiovascular
Disease
Soft Tissue Repair
< 2 hours
Cytori Celution® Regenerative cells
Versatile technology; focus on cardiac & soft tissue repair
CE Mark approval in Europe for soft tissue; Seeking CMI in 1H 2012
36+ patents, 100 + filed on device & cells
Celution™ System is not available in the US
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Acute Myocardial Infarction – The APOLLO Trial
APOLLO TRIAL• Prospective European Multicenter Trial
• Randomized (3:1)
• Double Blind
• Placebo controlled
• Blinded independent core labs
• Safety & Feasibility Trial
• n = 14 (4 placebo, 10 treated)
• Co-Principal Investigators: Drs. H.J. Duckers
and P.W. Serruys
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Perfusion defect in LAD territory:
Reduction in perfusion defect in patients treated with ADRC compared
to placebo patients as analyzed by MIBI SPECT (TSS scores)
MIB
I SP
EC
T TS
S c
ha
ng
e (
ma
tch
ed
pa
irs)
10ximprovement
9ximprovement
All SPECT images were assessed by an independent, blinded core lab (CCL, Boston, MA)
Cell Treated: Better Perfusion of the Heart6 & 18 month follow-up
p=NSSlide: Courtesy
HJ Duckers, MD, PhD
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p=NS
All MRI images were assessed by an independent, blinded core lab (CCL, Boston, MA)
Percent of Left Ventricle Infarcted (%LVI):Greater improvement in %LVI in ADRC patients vs. to Placebo control patients (late enhancement cMRI)
all pts baseline 6 mo
Placebo 24,7% 24,7%
ADRC 31,6% 15,4%
Matched-pair analysis
Means for treatment groups
Reduction of > 50% in Infarct Size seen with ADRCs6 & 18 month follow-up
ch
an
ge
in r
el.in
farc
t si
ze (
I/LV
) (m
atc
he
d p
airs)
Slide: Courtesy
HJ Duckers, MD, PhD
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All TTE images were assessed by an independent, blinded core lab (CCL, Boston, MA)
ch
an
ge
in E
SV
(c
c, 2
D T
TE)
Preservation of End-Systolic Volume with ADRCs6 & 18 month follow-up
24,4 ccimprovement
(-72,2%)
Change in ESV ESV was markedly reduced in ADRC patients as compared to placebo control patients
Slide: Courtesy
HJ Duckers, MD, PhD
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APOLLO: Arrhythmias
More ventricular arrhythmias observed in Control patients
More Significant Ventricular Arrhythmias in control patients
Higher frequency of recordings with Ventricular Premature Bits (VPB) in Controls
Higher number of VPBs per recording
in Controls
50%
30%
0%
10%
20%
30%
40%
50%
60%
Placebo Group1
PercentofPa entswithSignifica ntVentricularArrhythmias
0
100
200
300
400
500
600
700
0.5 1 2 3 4 8 12 16 25 52 77
PrematureVentricularContrac ons-MeanCountperPa ent
control
ADRC
0
500
1000
1500
2000
2500
3000
0.5 1 2 3 4 8 12 16 25 52 77
PrematureVentricularContrac ons-MeanCumula veCount
control
ADRC
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APOLLO: Summary
ADRCs are safe in the treatment of STEMI No safety concerns
Cell administration is safe
No new MACE/SAEs
No Deaths
Feasibility Concordant improvement in infarct and ischemia:
Mean reduction in Infarct Size is maintained to 18 months
Improvement in cardiac perfusion is maintained to 18 months
May have positive impact on arrhythmia in cell-treatment patents
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Cytori Cardiac Program: Present and Future
Celution™ System is CE Marked in the EU
Acute Myocardial Infarction:
• European APOLLO Trial – completing 36-mo FU• Pivotal European ADVANCE Trial – ramping up
• US trial in AMI – to follow ADVANCE
Chronic Myocardial Ischemia:• European PRECISE Trial – completing 36-mo FU
• US ATHENA Trial – IDE filed
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AMI - THE ADVANCE TRIAL
• Primary endpoint: cMRI infarct size at 6 months
• Randomized, Double-blind, Placebo-controlled
• N ≤ 360, at up to 35 sites in the EU
• 23 sites selected & committed
• Various states of regulatory process by country
• Co-PIs Drs. H.J. Duckers and G. Pompilio
• Independent blinded core labs will evaluate all imaging data
• Independent DMC provides safety oversight
• Independent CEC will adjudicate all germane events
• Currently enrolling & treating patients
18-mo data from Apollo support trial design for ADVANCE
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Thank you