Phase IIb data: Localized prostate Ca agent safe, well tolerated
Sophiris Bio Inc. recently provided an update from its phase IIb study of topsalysin for localized prostate cancer, including top-line safety and biopsy results from the patients who received a second administration of study drug, which appeared to be safe and generally well tolerated. Additional benefit was not observed on targeted biopsy 6 months after re-treatment with a second administration of topsalysin. As previously stated, 27% of patients (10/37) demonstrated a clinical response 6 months following a single administration of topsalysin. Six of the 10 clinical responders experienced complete ablation of their tumor. Based on these results, Sophiris Bio said it is moving forward with plans to propose a single phase III registration trial design using a single administration of topsalysin, which it will discuss with regulatory agencies in the coming months.
FDA alignment reached on phase III trial of hyperoxaluria therapy
Allena Pharmaceuticals, Inc. has reached alignment with the FDA on both the design of URIROX-2, its second pivotal phase III trial of reloxaliase in patients with enteric hyperoxaluria, and its strategy to pursue a Biologics License Application submission for reloxaliase using the accelerated approval regulatory pathway. Allena’s URIROX program consists of two pivotal phase III clinical trials, URIROX-1 and URIROX-2, which are designed to evaluate the safety and efficacy of reloxaliase in patients with enteric hyperoxaluria. URIROX-1 is currently enrolling patients, and Allena initiated URIROX-2 in the fourth quarter of 2018. The primary efficacy endpoint for URIROX-2 is the percent change from baseline in 24-hour urinary oxalate excretion measured during weeks 1-4, the same primary efficacy endpoint as URIROX-1.
Prostate Ca test to be developed on PCR-based platform
Genomic Health, Inc. and BiocartisGroup NV have expanded their exclusive collaboration into the field of urology with the development of an in vitro diagnostic version of the Oncotype DX Genomic Prostate Score (GPS) test on Biocartis’ Idylla platform and potentially additional cancer tests that can be performed locally by laboratory partners and in hospitals around the world. The Idylla Oncotype DX GPS test will be the first urology test to be developed on Biocartis’ fully automated, polymerase chain reaction-based Idylla platform, which offers a unique sample-to-result molecular diagnostics solution.
Positive preliminary phase III data reported for bladder cancer agent
Sesen Bio, Inc. reported positive preliminary efficacy data for the primary endpoint of its ongoing phase III registration trial, the VISTA Trial, of Vicinium for the treatment of patients with high-grade nonmuscle-invasive bladder cancer who have been previously treated with bacillus Calmette-Guérin (BCG) and deemed BCG-unresponsive. The data showed clinically meaningful complete response rates in evaluable carcinoma in situ patients at 3, 6, 9, and 12 months of follow-up in the trial consistent with the data in the completed phase I and phase II clinical trials. The agent continues to be generally well tolerated in treated patients.