Viventia Biotech reports final Vicinium Phase I/II bladder cancer data
Viventia Biotech Inc. reported final data from its recently completed dose escalation Phase I/II clinical trial of Vicinium(TM) in patients with high risk, non-invasive bladder cancer. The results were presented at the 102nd Annual Meeting of the American Urological Association. Vicinium(TM) is a fusion protein comprised of a humanized antibody fragment specific for the antigen EpCAM, conjugated to a cytotoxic protein, Pseudomonas exotoxin A.
The trial enrolled 64 patients who were refractory or intolerant to standard treatment (BCG therapy). Patients were dosed on a weekly basis for 6 weeks at escalating dose levels using intravesical instillation. Although designed as a phase I study, an efficacy analysis demonstrated that only 7% of these high risk patients progressed during the study period. Vicinium(TM) was very well tolerated at all dose levels with no maximum tolerated dose reached and no patient had a dose reduction or withdrawal due to toxicity.
"Patients with non-invasive bladder cancer, which comprise the majority of bladder cancers, that progress after failing conventional treatments usually require complete removal of the bladder to prevent further disease progression and avoid metastasis to other organs. Vicinium(TM), which was well-tolerated and provided an overall 93% disease control rate in a very high risk population, has the potential to someday substantially delay or eliminate the need for these more drastic options," said Dr. Nick Glover, President and CEO of Viventia Biotech. "Moreover, Vicinium(TM) has demonstrated an early safety profile far more favorable than the established therapies."
Patients were also monitored for duration of response following the completion of the protocol. Ongoing post hoc analyses demonstrated a sustainable response lasting more than 6 months in most of these patients, with many patients still disease free out to 12 months. Sustainability of response is being specifically assessed in an ongoing open-label Phase II trial of Vicinium(TM), which is currently enrolling patients with locally persistent non-invasive Cis bladder cancer in Canada and the U.S.
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