Enrollment Completed in Phase 3 Registration Trial for Non-Muscle Invasive Bladder Cancer
Eleven Biotherapeutics’ VISTA Trial of Vicinium™ in NMIBC On-Track for Topline Three-Month Data in Mid-2018
“Bladder cancer is one of the most prevalent cancers in
“We believe Vicinium is the most advanced candidate in development for
NMIBC and has the potential to be an effective and tolerable treatment
for patients who have been previously treated with BCG,” said Stephen
Hurly, president and chief executive officer of
About the VISTA Clinical Trial
The VISTA trial is an open-label, multicenter, single-arm Phase 3 clinical trial evaluating the efficacy and tolerability of Vicinium™ in patients with high-risk non-muscle invasive bladder cancer (NMIBC) that is carcinoma in situ (CIS, cancer found on the inner lining of the bladder that has not spread into muscle or other tissue) or papillary (cancer that has grown from the bladder lining out into the bladder but has not spread into muscle or other tissue), who have been previously treated with bacillus Calmette-Guérin (BCG). The primary endpoint of the trial is the complete response rate in patients with CIS with or without papillary disease. Patients in the study receive locally administered Vicinium twice a week for six weeks, followed by once-weekly treatment for another six weeks, then treatment every other week for up to two years. Topline data assessing responses and durability of responses at three-months on treatment are expected in mid-2018, with 12-month data anticipated in mid-2019. For more information, please visit www.mybladdercancer.com.
Vicinium™, Eleven Biotherapeutics’ lead product candidate, is a
next-generation antibody-drug conjugate developed using the company’s
proprietary Targeted Protein Therapeutics platform. Vicinium is
comprised of a recombinant fusion protein that targets epithelial cell
adhesion molecule (EpCAM) antigens on the surface of tumor cells to
deliver a potent protein payload, Pseudomonas Exotoxin A (ETA).
Vicinium is constructed with a stable, genetically engineered linker to
ensure the payload remains attached until it is internalized by the
cancer cell, which is believed to decrease the risk of toxicity to
healthy tissues, thereby improving its safety. In prior clinical studies
About Non-Muscle Invasive Bladder Cancer
Bladder cancer is the sixth most commonly diagnosed cancer in
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