VICINIUM
TRIALS
Past trials
In a Phase I clinical trial with Vicinium™
in patients with bladder cancer, results showed that Vicinium™
was well tolerated in most patients, with the most frequent
side effects reported being dysuria (pain or difficulty urinating;
14.1% of patients), hematuria (blood in urine; 10.9% of patients)
and fatigue (tiredness; 7.8% of patients),
Exploratory effectiveness was evaluated in
the trial with the following findings being reported:
VB4-845-02-I – Phase I Trial
Weekly dosings via intravesical instillation
once a week for 6 weeks followed by 6 weeks of no treatment.
Of the 61 Ep-CAM positive patients who were
considered evaluable at the end of the trial:
- 41% had complete response (no evidence of bladder cancer)
- 29% had a partial response
- 23% had stable disease
- 7% had progression
Preliminary results were initially presented
at the 42nd Annual Meeting of the American Society of Clinical
Oncology. (Abstract #4580). Final results were presented at
the 102nd Annual Meeting of the American Urological Association.
(Abstract #91750)
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