Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage clinical company advancing next-generation antibody-drug conjugate (ADC) therapies for the treatment of cancer, today announced that the company has completed enrollment in the VISTA Phase 3 registration trial of Vicinium™ in patients with non-muscle invasive bladder cancer (NMIBC) who have been previously treated with bacillus Calmette-Guérin (BCG). Bladder cancer is the sixth most common cancer in the United States and approximately 80 percent of bladder cancer patients are diagnosed with NMIBC. Vicinium is a fusion protein, designed to be a next-generation ADC, which specifically targets the epithelial cell adhesion molecule (EpCAM) antigens on the surface of bladder cancer cells to deliver a potent cytotoxin to those cells.
"Bladder cancer is one of the most prevalent cancers in the United States, yet there has been limited development of new therapeutic options for patients in more than 30 years," commented Donald Lamm, M.D., University of Arizona professor, director of BCG oncology and an investigator in the VISTA trial. "Today’s standard-of-care for NMIBC provides initial responses in many patients; however, after BCG is no longer effective, there are no meaningful FDA-approved options except surgical removal of the bladder in high-risk patients. I am encouraged by the data demonstrated with Vicinium in prior trials and its potential to offer my patients an alternative to radical cystectomy."
"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 Eleven Biotherapeutics. "The complete response rate and favorable safety seen in our Phase 2 trial were encouraging, and based on learnings from that trial, we modified the dosing regimen to potentially further enhance responses in the VISTA trial. With Phase 3 recruitment complete, we are on-track to report topline, three-month data in mid-2018, and look forward to further assessing Vicinium’s potential in treating patients with this devastating cancer."
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.
About Vicinium™
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 conducted by Eleven Biotherapeutics, EpCAM has been shown to be overexpressed in non-muscle invasive bladder cancer (NMIBC) cells with minimal to no EpCAM expression observed on normal bladder cells. Eleven Biotherapeutics is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicinium for the treatment of NMIBC in patients who have p...
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