Date: 2015-07-24
Type of information: Recruitment of the first patient
phase: 2
Announcement: recruitment of the first patient
Company: Bavarian Nordic (Denmark) National Cancer Institute (NCI) (USA)
Product: Prostvac® (rilimogene)
Action
mechanism: immunotherapy product/gene therapy. Prostvac® is a PSA-targeted, ready-to-use active immunotherapy for the treatment of prostate cancer. Administered subcutaneously, it induces a specific, targeted immune response that attacks prostate cancer cells. A robust data package has been established through 12 ongoing and completed clinical Phase 1 and Phase 2 trials, where more than 300 patients have been treated, and the immunotherapy candidate has been generally well-tolerated. A randomized, placebo-controlled Phase 2 trial demonstrated the potential of Prostvac® to extend the median overall survival by 8.5 months in patients with advanced prostate cancer. These results led to the initiation of the PROSPECT pivotal Phase 3 clinical trial study.
Concurrently with the Phase 3 study, Prostvac® is also being clinically investigated in both metastatic and non-metastatic prostate cancer, in combination with enzalutamide (Xtandi®). Previous clinical studies combining Prostvac® with other anti-androgen therapies or radiation therapy, either concomitantly or sequentially have indicated possible therapeutic synergies for these treatment combinations. In addition, preliminary evidence from pre-clinical and early clinical studies suggests potential for therapeutic synergy of combining Prostvac® with immune checkpoint inhibitors, and Bavarian Nordic is working further to explore this opportunity.
Prostvac® is being developed in collaboration with the National Cancer Institute under a Cooperative Research and Development Agreement. In April 2010, Prostvac® was granted Fast Track designation by the FDA for the treatment of men with asymptomatic or minimally symptomatic mCRPC.
Disease: prostate cancer
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: This randomized phase II trial studies how well Prostvac® (prostate-specific antigen [PSA]-TRICOM) works in preventing disease progression in patients with prostate cancer undergoing active surveillance. Vaccines made from a person's tumor cells may help the body build an effective immune response to kill tumor cells that express PSA. (NCT02326805)
Latest
news: * On July 24, 2015, Bavarian Nordic announced that the first patient has been enrolled in a new phase 2 clinical study of Prostvac® , the Company's active prostate cancer immunotherapy candidate. The study is designed as a randomized, double-blind, placebo-controlled study for men who have localized prostate cancer, and are undergoing active surveillance. These patients are not experiencing symptoms related to their cancer, and are not being treated with other therapies. The study is sponsored by the National Cancer Institute (NCI) as part of a Collaborative Research and Development Agreement (CRADA) and Clinical Supply Agreement between Bavarian Nordic and the NCI.
The study will be conducted across 6 sites, and is designed to enroll 90 patients with the potential to expand up to 150 patients. The primary endpoint of the study is to determine how well Prostvac® works in eliciting an immune response in patients with prostate cancer that is found only in the prostate and has not yet metastasized. Changes in CD8 and CD4 T cells in tissue adjacent to the tumor and within malignant portion of prostate biopsies will be measured as will changes in PSA. Secondary endpoints include effects of Prostvac® on changes in PD-L1 expression, PSA doubling time, and change in tumor grade (Gleason score). The principal investigator of the study is J. Kellogg Parsons, M.D., MHS, University of California San Diego.
