An Open-Label, Phase I Dose Escalation Trial of MVA-BN®-PRO in Men With Androgen-Insensitive Prostate Cancer
MVA-BN®-PRO is a candidate prostate cancer immunotherapy product comprised of a highly
attenuated non-replicating vaccinia virus, MVA-BN®, engineered to encode prostate specific
antigen (PSA) and prostate acid phosphatase (PAP) proteins. The MVA-BN®-based vaccine
provides innate and adaptive immune activating factors, and vaccination by this strategy
will be evaluated for its capacity to help override self and tumor tolerance mechanisms.
Previous work has shown PSA and PAP antigens to be immunogenic in humans when presented with
immune stimulatory components. Multiple clinical studies have demonstrated promising
activity of PSA-targeted vaccinia-based immunotherapy. Additionally, PAP-based cellular
therapy immunization approaches, have shown promise in Phase III clinical trials and
provided for enhanced survival. The strategy undertaken by BNIT is to combine both antigens
in the MVA-BN® vector to enhance the immunogenic effect and to help mitigate development of
tumor resistance.
This trial examines three vaccination regimens of MVA-BN®-PRO:
Vaccine is provided at (0.5cc/dose/1x10e8 TCID50)
- Cohort 1: 1 sc injection every 4 weeks x 3; retreated once at the same dose and
schedule.
- Cohort 2: 2 sc injections every 4 weeks x 3; retreated once at the same dose and
schedule.
- Cohort 3: 4 sc injections every 4 weeks x 3; retreated once at the same dose and
schedule.
These dose regimens are based on the current dose of MVA-BN® (1x10e8 TCID50 by sc injection)
under development as a prophylactic vaccine for the prevention of smallpox, and on related
clinical studies of MVA-nef-based vaccines (5x10e8 TCID50) for induction of heterologous
immunity.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the safety and tolerability of single and multiple injection regimens of MVA-BN®-PRO for the treatment of androgen-insensitive prostate cancer.
Continuous
No
Olga Bandman
Study Director
BN ImmunoTherapeutics
United States: Food and Drug Administration
BNIT-PR-001
NCT00629057
March 2008
September 2011
Name | Location |
---|---|
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
Urology Centers Of Alabama | Homewood,, Alabama 35205 |
Urology Associates | Nashville, Tennessee 37209 |
Lawrenceville Urology | Lawrenceville, New Jersey 08648 |
Presbyterian Hospital Center for Cancer Research | Charlotte, North Carolina 28204 |
Urology Associates of South Texas | McAllen, Texas 78503 |
Urology Clinics of North Texas, PA | Dallas, Texas 75231 |