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Table 3 Clinical effects in this phase I study

From: BK-UM in patients with recurrent ovarian cancer or peritoneal cancer: a first-in-human phase-I study

Patient no.

HB-EGF in serum (pg/mL)

HB-EGF in abdominal fluid (pg/mL)

Serum CA125 (IU/mL)

Anti-diphtheria toxin antibodies (IU/mL)

Efficacy

Pre-Tx

Post-Tx

Pre-Tx

Post-Tx

Pre-Tx

Post-Tx

Pre-Tx

Post-Tx

1

1971

196

2169

106

291

137

<0.01

2.56

SD

2

556

349a

416

560a

1411

3487

<0.01

124

PD

3

297

172

593

292

46

50

<0.01

>131

SD

4

267

85

143

34

1408

2217

0.04

>131

PR

5

51

101

55

399

267

600

0.03

31.1

SD

6

74

109

109

171

254

158

<0.01

81.9

PD

7

67

79

130

ND

2813

3983

<0.01

0.06

PD

8

162

141a

140

132a

3894

5147

0.13

20.5

PD

9

231

130

237

66

1856

3984

0.01

1.02

PD

10

247

140

ND

ND

40

63

<0.01

>41.0

SD

11

67

155a

ND

ND

16

94

<0.01

>6.56

SD

  1. Pre-A pre-administration of BK-UM, Post-A post-administration of BK-UM, ND not determined, SD stable disease, PD progressive disease, PR partial response
  2. aHB-EGF level was measured on the final day of investigation