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Viventia starts recruitment of clinical centers for Phase III bladder cancer trial of vicinium

Canada-based Viventia Bio has started approving clinical trial centers for participation in its pivotal Phase III human clinical trial for vicinium, a recombinant fusion protein, to treat high grade non-muscle invasive bladder cancer (NMIBC).

Following discussions with the US Food and Drug Administration (FDA), the company has finalized its clinical protocol and intends to begin patient enrollment within the next month at multiple sites in the US and Canada.

The company noted that the preliminary efficacy data from the trial is expected to be reported in the third quarter of next year.

Viventia chief executive officer Stephen Hurly said: "We are excited to launch patient enrollment imminently for vicinium, a highly differentiated, wholly biologic Targeted Protein Therapeutic designed to overcome the challenges and deficiencies of earlier-generation antibody drug conjugates.

"Vicinium has been administered to more than 100 patients in Phase I and II clinical trials.

"Clinical results to date have demonstrated complete response rates of greater than 40% at three months with no drug-related serious adverse events."

This open-label, multi-center Phase III trial will evaluate the efficacy and tolerability of intravesical administration of vicinium in patients with high grade NMIBC refractory to treatment with bacillus Calmette–Guerin (BCG).

The trial will be conducted at around 55 leading medical centers in the US and Canada.

Vicinium includes a single chain EpCAM-targeting antibody fragment genetically fused to truncated Pseudomonas exotoxin, or exotoxin A (ETA).