MADRID, September 11, 2017 - This morning at the European Society for Medical Oncology (ESMO) 2017 Congress, Dr. James Gulley, Chief, Genitourinary Malignancies Branch, Senior Investigator, Head, Immunotherapy Section, Director, Medical Oncology Service, CCR Office of the Clinical Director, NCI, and Principal Investigator on PROSPECT, the Phase 3 study of PROSTVAC, will provide a presentation entitled “Therapeutic Vaccines in Prostate Cancer”, including several blinded observations of the ongoing PROSPECT Phase 3 study.
As part of the presentation Dr. Gulley will highlight the blinded Kaplan-Meier curve for overall survival (OS) in the PROSPECT study for all patients, active and placebo. Dr. Gulley will also show this blinded median OS broken down by various geographies.
As the PROSPECT study is still ongoing, with full data expected in 2017, the data presented today are preliminary and fully blinded to the company and investigators and as such, no firm conclusions can be drawn about the eventual outcome of the PROSPECT Phase 3 study.
Following this presentation, a copy of the slides presented by Dr. Gulley can be found by visiting www.bavarian-nordic.com under “Investors > Events & Presentations”.
About the PROSPECT study
The PROSPECT study is a global randomized, double-blind, placebo-controlled study in patients with asymptomatic or minimally symptomatic mCRPC. The trial is being conducted under a Special Protocol Assessment agreement with the FDA. The primary objective of the study is to determine whether the overall survival of patients receiving PROSTVAC (with or without the addition of granulocyte macrophage colony-stimulating factor; GM-CSF), is superior to that of patients receiving placebo.
The study completed recruitment in January of 2015 with a final enrolment of 1,297 men. Based on the dosing schedule of PROSTVAC, all men would have completed their course of therapy no later than June 2015.
Three pre-specified interim analyses of data have been integrated into the statistical plan to evaluate whether the trial should continue as planned, or potentially be stopped early for efficacy or futility. Two of these interim analyses have already occurred, with the conclusion that the study should continue without modification. The third interim analysis is expected to occur in September 2017 with final data expected in the fourth quarter of 2017.
About Bavarian Nordic
Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of cancer immunotherapies and vaccines for infectious diseases, based on the Company’s live virus vaccine platform. Through long-standing collaborations, including a collaboration with the U.S. government, Bavarian Nordic has developed a portfolio of vaccines for infectious diseases, including the non-replicating smallpox vaccine, IMVAMUNE®, which is stockpiled for emergency use by the United States and other governments. The vaccine is approved in the European Union (under the trade name IMVANEX®) and in Canada. Bavarian Nordic and its strategic partner Janssen are developing an Ebola vaccine regimen, and therapeutic vaccines for HPV, HBV and HIV. Additionally, in collaboration with the National Cancer Institute, Bavarian Nordic has developed a portfolio of active cancer immunotherapies, including PROSTVAC®, which is currently in Phase 3 clinical development for the treatment of advanced prostate cancer. The company has partnered with Bristol-Myers Squibb for the potential commercialization of PROSTVAC. For more information visit www.bavarian-nordic.com or follow us on Twitter @bavariannordic.
Contacts
Rolf Sass Sørensen
Vice President Investor Relations (EU)
Tel: +45 61 77 47 43
Seth Lewis
Vice President Investor Relations (US)
Tel: +1 978 341 5271
Press Release
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