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.