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Viventia Biotech to Explore Strategic Alternatives - Reports Positive Pivotal Phase III Interim Efficacy Data
Date:1/29/2008

sion. Vicinium(TM) has demonstrated an excellent safety profile, showing little evidence of side effects, unlike the relatively high toxicity associated with other forms of intravesical therapy, including BCG.

VB6-845

VB6-845 is a humanized antibody fragment targeting EpCAM fused with the Company's proprietary deimmunized form of the cytotoxic protein Bouganin, and is designed for systemic use against metastatic cancers. VB6-845 is currently in a Phase 1 dose escalation trial in patients with solid tumors, which is designed primarily to establish the safety and tolerability of the drug. The study is also structured to provide preliminary evidence of the efficacy of this novel cytotoxic conjugate. Approximately 40-50 patients with an advanced EpCAM-positive epithelial cancer will receive VB6-845 intravenously on a weekly treatment schedule.

The study has currently enrolled 12 patients, with the longest treatment duration being 16 weeks. Encouraging early signs of anti-tumor activity include demonstrable stabilization of disease in several patients, as well as objective signs of tumor responses, and signs of improvement in disease-related sequelae in some patients. Preliminary immunogenicity data reveal anti-Bouganin levels that are either below or near the limit of detection, demonstrating the highly successful deimmunization of the protein.

VB6-845 has demonstrated effective cancer cell killing properties in pre-clinical tests. A full array of animal efficacy studies and safety studies of VB6-845 for the treatment of ovarian cancer and other solid tumors has been completed. In animal xenograft studies, VB6-845 elicited 100% complete cures of established ovarian tumors. VB6-845 has been shown to be safely tolerated in both primate and rodent animal safety studies.

Viventia's antibody and target discovery platform

Viventia has built a proprietary technology platform to discover and advance the next generation of anti-cancer mo
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SOURCE Viventia Biotech Inc.
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