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Phase II Study To Evaluate Efficacy/Tolerability Of Intravesical Vicinium In Patients With Carcinoma In SITU Treated With Bacille Calmette-Guérin

ORLANDO, FL (UroToday.com) - Vicinium™ is a fusion protein comprised of a humanized scFv, specific for EpCAM (epithelial cell adhesion molecule), and a truncated fragment of Pseudomonas exotoxin A. EpCAM is highly expressed on carcinoma cells including transitional cell carcinomas (TCC) of the bladder. Vicinium specifically targets and induces apoptosis in EpCAM positive tumors resulting in cell death. The authors have previously reported that it Vicinium is well tolerated in a phase I intravesical study in 64 patients with non-invasive urothelial carcinoma. The authors presented preliminary efficacy and tolerability results from a Phase II study of Vicinium instilled into the bladders of patients with BCG refractory carcinoma in situ (CIS).

46 patients with EpCAM positive CIS of the bladder, who were refractory or intolerant to BCG therapy, were entered into the study. Vicinium was given either weekly for 6 weeks followed by 6 weeks of no therapy and if no tumor seen placed on maintenance therapy or for 12 weeks and then maintanence therapy if not tumor seen. Patients who were free of disease continued to receive maintenance dosing up to a maximum of Week 57. All toxicities were assessed according to the NCI CTC AE v3. Efficacy was determined via directed and random biopsies, cystoscopy, and urine cytology.

21 patients have been enrolled to date and preliminary data supports an excellent safety and tolerability profile. The Recurrence-free survival is shown below.

3 months
6 Week tx 41% - 12 Week tx 50% - Overall 43%

6 months
6 Week tx 33% - 12 Week tx n/a - Overall 33%

Presented by Mark Kowalski, MD, Nicola Jones, MD, Michael A S Jewett, MD, Wendy Cuthbert, MD, Nick Glover, MD, Cal Andreou, MD, Cary Robertson, MD, Allan Toguri, MD, at the Annual Meeting of the American Urological Association (AUA) - May 17 - 22, 2008. Orange County Convention Center - Orlando, Florida, USA.

Reported by UroToday.com Contributing Editor David P. Wood, MD

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Etapa II de studiu pentru a evalua eficacitatea / tolerabilitãþii Intravesical Vicinium la pacienþii cu carcinomul in situ trataþi cu Bacille Calmette-Guérin - Phase II Study To Evaluate Efficacy/Tolerability Of Intravesical Vicinium In Patients With Carcinoma In SITU Treated With Bacille Calmette-Guérin - articole medicale engleza - startsanatate