PROSTVAC is Bavarian Nordic’s lead targeted immunotherapy candidate that is being investigated for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). Encouraging results from the PROSTVAC development program are being validated with the ongoing pivotal phase 3 PROSPECT study, conducted in collaboration with the National Cancer Institute under a Special Protocol Assessment from the US Food and Drug Administration (FDA). Data to date also suggest that PROSTVAC has potential in combination with other therapies and/or in earlier stages of the disease.
The purpose of this study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer.
|Prostate Cancer Metastatic||Biological: PROSTVAC-V
Other: GM-CSF Placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer|
Study Start Date:December 2011
Estimated Study Completion Date:August 2016
Estimated Primary Completion Date:December 2015 (Final data collection date for primary outcome measure)[/td_text_with_title][td_text_with_title custom_title=”Latest post”]
From Bavarian Nordic
Bavarian Nordic to receive up to $975 million, inclusive of $60 million upfront and potential exercise payment; potential development, regulatory and commercialization milestone payments; additional tiered double-digit royalties on future sales KVISTGAARD, Denmark and NEW YORK, March 4, 2015 – Bavarian Nordic (OMX: BAVA, OTC: BVNRY) and Bristol-Myers Squibb Company (NYSE: BMY) announced today an […]