Date: May 20, 2015
|
KAMADA LTD.
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By: /s/ Gil Efron
|
|
Gil Efron
Chief Financial Officer
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EXHIBIT NO.
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DESCRIPTION
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99.1
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A Slide Presentation - Inhaled AAT Phase 2/3 Study Results - May 2015.
|
|
AAT
(N=85)
|
Placebo
(N=83)
|
Males
Females
|
51 (60.0%)
34 (40.0%)
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49 (59.0%)
34 (41.0%)
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Mean age ± SD (years)
Age ≥ 60 years
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56.5 ± 9.9
38 (44.7%)
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54.4 ± 10.3
26 (31.3%)
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Race: Caucasian
|
79 (100%)
|
75 (100%)
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BMI (kg/m2): mean ± SD
BMI <20
|
25.8 ± 4.6
8 (9.4%)
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26.3 ± 5.5
4 (4.8%)
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Oxygen users
|
18 (21.2%)
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10 (12.0%)
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FEV1 (L): mean ± SD
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1.32 ± 0.49
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1.33 ± 0.53
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FEV1% (%): mean ± SD
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42.8 ± 14.8
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41.8 ± 14.7
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DLCO (mMol/min/kPa): mean ± SD
|
4.23 ± 1.61
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4.59 ± 1.96
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Lung
Function |
Least Squares Means (SE)
(Changes at Week 50 from Baseline) |
P-Value
(Changes at Week 50) |
Least Squares Means
(SE) (overall treatment effect) |
P-Value
(Overall Effect) |
||
AAT
(N= 84)
|
Placebo
(N= 81)
|
AAT
(N= 84)
|
Placebo
(N= 81)
|
|||
FEV1 (L)
|
-12mL
-0.01183
(0.02196) |
-62mL
-0.06216
(0.02036) |
0.0956
|
+15mL
0.01503
(0.01338) |
-27mL
-0.02718
(0.01322)
|
0.0268
|
FEV1 (% of
predicted) |
-0.1323
(0.6649)
|
-1.6205
(0.6140)
|
0.1032
|
0.5404
(0.4451)
|
-0.6273
(0.4425)
|
0.0658
|
FEV1/SVC
(%) |
0.6183
(0.5015)
|
-1.0723
(0.4455)
|
0.0132
|
0.6230
(0.3931)
|
-0.8715
(0.3804)
|
0.0074
|
Lung
Function |
Least Squares Means
(SE) (Changes at Week 50 from Baseline) |
P-Value
(Changes at Week 50) |
Least Squares Means
(SE) (overall treatment effect) |
P-Value
(Mixed Linear Model - Overall Treatment Effect) |
||
AAT
(N= 84)
|
Placebo
(N= 81)
|
AAT
(N= 84)
|
Placebo
(N= 81)
|
|||
DLCO
|
-0.2704
(0.07713)
|
-0.3054
(0.07182)
|
0.7407
|
-0.2011
(0.05585)
|
-0.1640
(0.05577)
|
0.6401
|
DLCO (% of
predicted) |
-2.9103
(0.9058)
|
-3.5785
(0.8459)
|
0.5920
|
-2.1459
(0.6721)
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-1.8723
(0.6734)
|
0.7748
|
DLCO/VA
|
-0.02858
(0.01359)
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-0.02464
(0.01299)
|
0.8349
|
-0.02672
(0.01061)
|
-0.00953
(0.01071)
|
0.2580
|
DLCO/VA (%
of predicted) |
-2.1951
(0.9686)
|
-1.8049
(0.9232)
|
0.7720
|
-2.0143
(0.7777)
|
-0.7094
(0.7851)
|
0.2415
|
ITT
|
N (%)
|
P Value
|
|
AAT
|
Placebo
|
||
Type/Category
|
N=85
|
N=83
|
|
Type I
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16 (18.8%)
|
26 (31.3%)
|
0.0614
|
Type II
|
23 (27.1%)
|
12 (14.5%)
|
0.0444
|
Type III
|
34 (40.0%)
|
33 (39.8%)
|
0.9746
|
None
|
12 (14.1%)
|
12 (14.5%)
|
0.9498
|
Symptom
|
Exac. Type
|
Days
|
MMRM
Least Square Means |
P-Value*
|
|
AAT
N=73 |
Placebo
N=71 |
||||
Dyspnea
|
All Types (I, II, III)
|
0-10
|
11.9464
|
12.2548
|
0.0243
|
0-14
|
11.5803
|
11.7832
|
0.0817
|
||
Sputum
Volume |
0-10
|
1.2748
|
1.3837
|
0.0334
|
|
0-14
|
1.2367
|
1.3206
|
0.0595
|
||
Sputum
Color |
0-10
|
2.1566
|
2.0137
|
0.0502
|
|
0-14
|
2.0240
|
1.8393
|
0.0032
|
Month
|
AAT
|
Placebo
|
1
|
1.75
|
1.14
|
2
|
0.78
|
0.69
|
3
|
0.96
|
0.71
|
4
|
0.87
|
0.53
|
5
|
0.71
|
0.9
|
6
|
0.78
|
0.47
|
7
|
0.63
|
0.51
|
8
|
0.6
|
0.59
|
9
|
0.63
|
0.74
|
10
|
0.78
|
0.53
|
11
|
0.37
|
0.51
|
12
|
0.83
|
0.71
|
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