Another exciting milestone for DF/Net client, Inovio Pharmaceuticals, Inc.
Inovio Presents Progression Free Survival & PSA Doubling Time Improvements in Prostate Cancer Patients Treated with INO-5150
Study Results Presented at a Major European Cancer Conference (ESMO)
PLYMOUTH MEETING, Pa., October 22, 2018 -- Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that new data from the company’s recently completed Phase 1b study with INO-5150 demonstrated a slowing of Prostate-Specific Antigen Doubling Time (PSADT) in men with prostate cancer. Eighty six percent (86%) of patients remained progression-free at Week 72 of the study. These data were presented in a poster entitled “Synthetic DNA immunotherapy in Biochemically Relapsed Prostate Cancer” at the European Society for Medical Oncology (ESMO) 2018 congress in Munich today.
In this study, Inovio evaluated the tolerability and immunogenicity of INO-5150, a DNA vaccine encoding PSA and PSMA, with or without INO-9012 (encoding IL-12 immune adjuvant), in men with biochemically relapsed prostate cancer. The study demonstrated a slowing of PSA doubling time, a measure of disease progression, in a majority of patients on the study. In addition, 86% of patients were progression-free at Week 72 of the study, which in this treatment-refractory, high-risk patient population, is thought to be clinically promising. Importantly, analyses demonstrated that immunogenicity was observed in 77% (47/61) of patients by multiple immunologic assessments. Continue reading on the Inovio website.
DF/Net was the data management and analytics service provider for this study. This was a 100% EDC study with all data entered into the database at site level. DF/Net performed day-to-day study data cleaning utilizing iDataFax reports and edit checks, served as a liaison between the site, monitors, and client regarding data management issues, and performed MedDRA coding. The DF/Net Data Analytics team programmed cross-plate SAS checks to ensure that all discrepancies were accounted for.