Uro Pipeline: Trial to evaluate PCa immunotherapy in men undergoing AS

Trial to evaluate PCa immunotherapy in men undergoing surveillance

Dendreon Pharmaceuticals LLC says it will conduct a large-scale, placebo-controlled clinical trial evaluating the effectiveness of sipuleucel-T (PROVENGE) in reducing disease progression in men with prostate cancer on active surveillance (AS). The ProVent clinical trial will assess the efficacy of sipuleucel-T in reducing histopathologic disease progression in men on AS, with a targeted enrollment of 450 participants. Men age 18 years or older who have histologically proven adenocarcinoma of the prostate diagnosed within 12 months of randomization are eligible to enroll. Study enrollment is expected to begin in late 2018, with topline results expected in 2023, Dendreon reported.

PSMA-targeted agents are focus of new rights agreement

Blue Earth Diagnostics has signed an agreement with Scintomics GmbH, Germany, a specialist in radiopharmaceuticals and radiopharmaceutical technologies under which Blue Earth Diagnostics has acquired the exclusive rights to a family of prostate-specific membrane antigen (PSMA)-targeted radiohybrid (“rh”) agents for cancer imaging, together with an exclusive option to explore therapeutic applications. Blue Earth Diagnostics will drive development of a lead 18F rhPSMA imaging compound and collaborate with Scintomics to identify therapeutic candidates for future development. Blue Earth Diagnostics says acquisition of the rights to this advanced technology provides strong synergies with fluciclovine F 18 (Axumin), Blue Earth Diagnostics’ positron emission tomography/computed tomography imaging agent for use in patients with a rising PSA after prior prostate cancer treatment. Separately, Blue Earth announced results of a clinical trial indicating that 59% of patients had their clinical management changed when results of the ¹⁸F fluciclovine were added to the diagnostic workup. Of those changes, 78% were classified as “major” (change in treatment modality), researchers reported at the 2018 AUA annual meeting.

PCa agent injected into gland completes dose-escalation phase

NanOlogy has completed the dose-escalation phase of an open-label clinical trial of submicron particle paclitaxel sterile suspension (NanoPac) injected directly into the tumor area for treatment of prostate cancer. Successful completion of the dose-escalation phase has allowed the highest concentration of NanoPac to begin the dose confirmation phase of the trial, which will continue to generate data on safety and tumor response. The phase IIa trial is enrolling patients with localized prostate cancer scheduled for prostatectomy. In the trial, patients receive intratumoral injection of NanoPac 28 days before surgery. Tumor volume and prostate tissue biopsy taken prior to NanoPac administration is compared to tumor volume and tissue after surgery. In the dose-escalation phase, to determine highest concentration of drug that can be safely administered, 6 mg/mL, 10 mg/mL, and 15 mg/mL concentrations of NanoPac were each injected into three patient cohorts followed by safety review for each cohort. No drug-related serious adverse events were reported in any of the cohorts, and preliminary data show evidence of tumor reduction and tumor cell death, NanOlogy reported.

Next: Agreement may lead to gene therapy option for bladder cancerAgreement may lead to gene therapy option for bladder cancer

Ferring Pharmaceuticals has signed an agreement giving the company the option to secure global commercialization rights to nadofaragene firadenovec/Syn3 (rAd-IFN/Syn3), a novel gene therapy being developed by FKD Therapies Oy (FKD) as a treatment for patients with high-grade nonmuscle-invasive bladder cancer (NMIBC) who are unresponsive to bacillus Calmette-Guérin (BCG) therapy. The option is exercisable on marketing approval from the FDA. Ferring says it will create a new U.S. oncology division with the specialist knowledge and presence to introduce novel advanced therapies to the market. rAd-IFN/Syn3 is currently undergoing phase III development in the U.S. under the sponsorship of FKD. Results of a phase II trial, published in the Journal of Clinical Oncology, reported 35% of BCG-unresponsive NMIBC patients given one dose of rAd-IFN/Syn3 every 3 months were free of high-grade disease at 1 year. An ongoing phase III study is designed to establish efficacy and safety. rAd-IFN/Syn3 has been awarded Fast Track and Breakthrough Therapy designations by the FDA.

Promising preliminary PCa focal therapy data presented

EDAP TMS announced that preliminary results of the first U.S. clinical cohort study of focal therapy, using the company's Ablatherm Robotic high-intensity focused ultrasound system for partial-gland ablation, demonstrated promising outcomes in prostate cancer patients. Patients participating in the study, conducted by the University of Miami Miller School of Medicine, experienced fewer side effects of incontinence and erectile dysfunction commonly associated with treatments such as surgery and radiation therapy. The data were presented at the Southeastern Section of the AUA annual meeting in Orlando, FL.

Bladder Ca surveillance panel: Pre-clinical validation complete

Exosome Diagnostics, Inc. recently completed its pre-clinical validation of a urine-based, gene expression panel intended for use as a rule-out for bladder cancer and as a rule-in for bladder cancer recurrence in a surveillance population. Results show a 100% negative predictive value NPV and 100% sensitivity for rule-out of bladder cancer among two separate cohorts of 24 and 57 patients. The panel additionally shows 100% positive predictive value and 100% specificity for rule-in of bladder tumor recurrence. Exosome Diagnostics is now actively recruiting for further clinical validation.