Newly Diagnosed Intermediate and High Prostate Cancer
We are currently conducting a fully blinded, randomized, placebo controlled phase 3 clinical trial using our GMCI in combination with the standard of care in intermediate and high-risk localized prostate cancer patients choosing radiation therapy. This 711 patient study is being conducted with a relatively short-term primary endpoint for this indication and under a Special Protocol Assessment (SPA) agreement with the FDA. Patients are being randomized 2:1 (active vs. placebo) and stratified based on NCCN risk group and whether a patient chooses to take short term neoadjuvant androgen deprivation therapy. Results to date from our early clinical studies in prostate cancer, including newly diagnosed prostate cancer, have been extremely promising.
Prevention of prostate cancer recurrence in intermediate and high risk patients is the goal of Advantagene’s (d.b.a. Candel Therapeutics) Phase 3 study. There is currently no other pharmaceutical or biopharmaceutical treatment approved for this indication or in late state clinical development. Successful development of GMCI for this indication will provide urologists with a new treatment option for their patients.
Newly Diagnosed Low Risk Prostate Cancer
More than 50% of patients are diagnosed at early stages of disease with low grade, low volume, asymptomatic prostate cancer. Active surveillance (AS) is an approach to manage patients with regular PSA and biopsy monitoring of disease status with the intent of deferring radical treatment. Radical treatment is nonetheless initiated in 25-30% of patients that commence AS within 2-3 years of diagnosis due to Gleason grade, tumor volume and/or PSA progression or patient choice due to “PSA anxiety.” GMCI may provide these patients with a low risk active intervention, and have the potential to delay or prevent progression without the need for surgery or radiation and their related side effects.
Advantagene has finished enrolling in a Phase II study in localized prostate cancer patients choosing active surveillance – we call this course of action “Proactive Surveillance.” Currently, we are awaiting a data analysis. This 189-patient study is a fully blinded placebo controlled clinical study randomized 2:1 (active: placebo). Currently with no treatment options but to monitor the progression of their disease, these patients will receive two GMCI treatments (as opposed to three in PrTK-03). The primary endpoint is the “ProActive Surveillance Score” – a composite endpoint consisting of PSA, DRE exam, and Gleason score that will be used to design a pivotal clinical trial in collaboration with the FDA should this study be successful. Secondary endpoints include progression to additional treatment, pathological response, PSA kinetics, quality of life and immune biomarkers.