Final data published in Phase I/II clinical trial of bladder cancer drug

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Viventia Biotech Inc., a privately held biopharmaceutical company have secured final data from its dose escalation Phase I/II clinical trial of Vicinium(TM) in patients with high risk, non-invasive bladder cancer.

64 patients intolerant to standard treatments were enrolled in the trial, each 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.

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.

Results from the trials indicated 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.

A fusion protein, Vicinium(TM) is comprised of a humanized antibody fragment specific for the antigen EpCAM, conjugated to a cytotoxic protein, Pseudomonas exotoxin A. Further details on Vicinium(TM) and this clinical trial are available at www.vicinium.com

Approximately 60,000 new cases of bladder cancer are diagnosed each year, with an estimated 15,000 deaths attributed to the disease annually.