Past
Trials
Two clinical trials have
currently been completed with Proxinium™ in patients
with Head and Neck Cancer. Both studies showed that Proxinium™
was well tolerated in the patients with the most frequent
side effects reported being injection site reactions (50%
of patients), flu-like symptoms (45% of patients), injection-site
pain (30% of patients) and some elevated liver function
laboratory tests (20% of patients).
Exploratory effectiveness
was evaluated in each trial with the following findings
being reported:
VB4-101 –
Phase I/II Trial
Daily intratumoral injection
for 5 days followed by 23 days rest and then daily injections
again for 5 days
Of the 14 Ep-CAM positive
patients who were considered evaluable at the end of the
trial:
- 43% had complete response (complete
disappearance of treated tumor)
- 28.5% had stable disease
- 28.5% had progression
VB4-101A –
Phase I/II Trial
Weekly intratumoural injection
for 4 weeks
Of the 18 Ep-CAM positive
patients who were considered evaluable at the end of the
trial:
- 25% had complete response (complete
disappearance of treated tumor)
- 37.5% had partial response
- 25% had stable disease
- 12.5% had progression
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