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|
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Up to December 2009 a total of 80 patients received Hamsa-1. The patients were enrolled in 3 clinical studies and a compassionate use program. The total human exposure through December 2009 exceeded 24 patient years, with treatment duration ranging from 1 week to 3 years as summarized in the Table below:
|
Study Title
|
Study ID /
Status
|
Design
|
Enrolled subjects (N)
|
Treatment Formulation
|
Treatment Duration (weeks)
|
|
Hamsa-1
metastatic CRPC
|
|
Open-label single arm Assessment of product efficacy, safety and tolerability
|
24
|
|
Range: 1-23
Mean: 8
Median: 6
Study ongoing and enrolling
|
|
Hamsa-1
Solid Tumors
|
4237/2006
Completed
|
Open-label single arm
Assessment of product safety and preliminary efficacy
|
31
|
|
Range: 2-151
Mean: 21
Median: 12
|
|
Hamsa-1 Glioblastoma
|
07-208
Completed
|
Open-label single arm
Assessment of product safety and preliminary efficacy
|
11
|
|
Range: 1-13
Mean: 6.8
Median: 4
|
|
Hamsa-1
Solid Tumors
|
NA
|
Compassionate use (open label)
|
14
|
|
Range: 1-49
Mean: 20.4
Median: 13
|
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