Saylor is content managing editor for Urology Times.
Other pipeline products discussed in this article include an immunotherapy for metastatic bladder cancer, a treatment for lower urinary tract symptoms of BPH, and an investigational clear cell renal cell carcinoma treatment.
First patients treated in phase III study of investigational BPH therapy
Peter Gilling, MD, of Urology Bay of Plenty, Tauranga, New Zealand, has treated the first patients in a global phase III clinical study evaluating the safety and effectiveness of the AquaBeam System as compared to the current standard of care, transurethral resection of the prostate. The AquaBeam System, which is being developed by PROCEPT BioRobotics, combines image guidance and robotics to deliver Aquablation, a waterjet ablation therapy that enables targeted, controlled, and heat-free removal of the tissue for the treatment of lower urinary tract symptoms caused by BPH. The WATER study (Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue) is a prospective randomized U.S. investigational device exemption clinical trial of male patients between the ages of 45 and 80 years who have urinary symptoms due to BPH. The study will enroll over 200 patients in up to 20 global sites, including 12 sites in the United States.
Pivotal phase II results announced for cancer immunotherapy
The investigational cancer immunotherapy atezolizumab shrank tumors (objective response rate) in 27% of people with metastatic urothelial carcinoma whose disease had medium and high levels of PD-L1 expression and worsened after initial treatment, according to results from a pivotal phase II study, IMvigor 210. Ninety-two percent of people who responded to atezolizumab continued to respond when the results were assessed. Median duration of response was not yet reached. Adverse events were consistent with those observed in previous studies. Developer Genentech said these data will be submitted to global health authorities and to the FDA under atezolizumab’s breakthrough therapy designation for the treatment of people whose metastatic bladder cancer expresses PD-L1.
Phase III data: LUTS Tx significantly improves IPSS over 12 months
Sophiris Bio Inc. recently announced final results from its phase III “PLUS-1” study of PRX302 as a treatment for lower urinary tract symptoms of BPH. PRX302 demonstrated a statistically significant improvement in International Prostate Symptom Score total score from baseline over 12 months compared to the vehicle-only control group (7.60 vs. 6.58-point overall improvement; p=.043), the primary endpoint of the study. PRX302 continues to demonstrate a favorable safety profile, with no evidence of any treatment-related sexual or cardiovascular side effects, Sophiris Bio reported.
Company to produce investigational PET prostate cancer biomarker
Siemens’ PETNET Solutions Inc. will formulate the VPAC1 molecular biomarker 64Cu TP-3805 exclusively for clinical trials for the biopharmaceutical firm NuView Life Sciences, Inc., of Park City, UT. Targeting the VPAC1 receptor over-expressed on the surface of malignant cancer cells, 64Cu TP-3805 is being studied for prostate and breast cancer imaging using positron emission tomography/computed tomography (PET/CT) and PET/magnetic resonance imaging. As a 64Cu-labeled peptide with a longer half-life (12.7 hours), 64Cu TP-3805 is better suited for clinical trial distribution across a large geographical area than other commonly used PET radiopharmaceuticals, Siemens AG said in a press release.
FDA allowance announced for investigational clear cell RCC Tx
X4 Pharmaceuticals has announced FDA allowance of the company’s investigational new drug application for the clinical study of X4P-001, the company’s lead drug candidate, in patients with refractory clear cell renal cell carcinoma. X4P-001 is a CXCR4 inhibitor designed to block non-cancerous immunosuppressive and pro-angiogenic cells from populating the tumor microenvironment, thereby restoring anti-tumor immune function. X4 said the first patient in the phase Ib/IIa study is expected to be dosed in the first quarter of 2016, and the study will take place at multiple cancer centers with leading renal cell carcinoma research located in the United States.
Agreement reached to use bladder cancer assay in clinical study
MDxHealth SA reports that it has entered into an agreement with Erasmus University Medical Center Rotterdam (Erasmus MC) for the inclusion of MDxHealth’s AssureMDx for Bladder Cancer, a urine-based, liquid biopsy test, into a prospective clinical study designed to assess the ability of urine-based molecular tests to stratify patients with nonmuscle-invasive bladder cancer (NMIBC) for recurrence monitoring. A total of 2,000 urine samples from 435 patients will be collected in a multicenter, two-arm, prospective randomized clinical trial financed by ZonMw, the Netherlands Organisation for Health Research and Development and Erasmus MC. The study is designed to assess the test’s ability to safely reduce the number of invasive cystoscopies performed during follow-up of patients with NMIBC with a low/intermediate risk of recurrence or progression. The study will also examine whether the addition of urine tests to follow-up of patients with higher risk of recurrence and progression leads to earlier detection of potentially dangerous recurrences. All urine samples will be tested using the AssureMDx assay.
Phase IIa study of infection agent yields positive topline results
Synthetic Biologics, Inc. recently announced positive topline results from the first phase IIa study of SYN-004, the company’s candidate designed to protect the gut microbiome from the unintended effects of certain commonly used intravenous beta-lactam antibiotics for the prevention of Clostridium difficile infection and antibiotic-associated diarrhea. Topline results from the 10 ileostomized participants who completed the phase IIa open-label study demonstrated that SYN-004 successfully degraded residual IV ceftriaxone in the chyme without affecting the intended level of ceftriaxone in the bloodstream, Synthetic Biologics reported.
Metastatic renal cell carcinoma agent found safe, well tolerated
Interim clinical data from an ongoing phase IIa study of its novel anti-cancer drug candidate, Archexin, was presented at the 2015 International Kidney Cancer Symposium in Miami. The ongoing phase IIa clinical study is designed to evaluate the efficacy of Archexin in combination with everolimus (Afinitor) to treat metastatic renal cell carcinoma patients and is being conducted in two stages. The interim results show that at the dose levels tested to date, Archexin appeared to be safe and well tolerated, developer Rexahn Pharmaceuticals reported.
Patient enrollment met for studies of female sexual dysfunction drug
Palatin Technologies, Inc. has achieved its patient enrollment target in its two pivotal phase III clinical studies of bremelanotide for the treatment of female sexual dysfunction. Each North American reconnect study is a multicenter (~80 sites), randomized, placebo-controlled, parallel-group, 8-month trial with an open-label extension phase. The clinical trials are designed to randomize approximately 1,100 women (~550 each trial) to evaluate the efficacy and safety of subcutaneous bremelanotide in premenopausal women with hypoactive sexual desire disorder as an on-demand, as-needed treatment.
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