Witjes - Figure 45
Other immunotherapy in high-risk patients
FIG. 45: Among the other therapies that are progressing in Phase 2 or 3 studies is mistletoe plant extract. In a study with AVF2 mistletoe plant (Viscum album L) extract, tumor marker response rate after 12 weeks was significant, at 55.6%.[34] Unfortunately, the 1-year recurrence rate was 26.3%. However, that means that more than half these patients were free of recurrence at 1 year, so this study was followed by initiation of a Phase 3 clinical trial.[35]
The same goes for diphtheria toxin BC-819 (diphtheria toxin-A). BC-819 is a double-stranded DNA plasmid that carries the gene for the A subunit of diphtheria toxin. It induces tumor cell destruction under the regulation of the H19 gene promoter. Around 50 patients were treated with BC-819 in a Phase 2b study and, similar to the trial with AVF2, there was a lower complete response of a marker lesion, but most of the patients who had a response remained recurrence-free at 1 year.[36] Two-thirds of the patients had no new recurrence. This study is being followed by Phase 2 and Phase 2 clinical trials.[37]
References
Rose A, El-Leithy T, vom Dorp F, et al. Mistletoe plant extract in patients with nonmuscle invasive bladder cancer: results of a Phase Ib/IIa single group dose escalation study. J Urol. 2015;194:939−43 http://dx.doi.org/10.1016/j.juro.2015.04.073
Abnoba GmbH. TIM – Intravesical mistletoe extract in superficial bladder cancer: A Phase III efficacy study. AB 40/11-TIM http://www.auo-online.de/ Accessed August 5, 2017
Gofrit ON, Benjamin S, Halachmi S, et al. DNA based therapy with diphtheria toxin-A BC-819: a Phase 2b marker lesion trial in patients with intermediate risk nonmuscle invasive bladder cancer. J Urol. 2014;191:1697−702 http://dx.doi.org/10.1016/j.juro.2013.12.011
BioCanCell clinical development plan for BC-819. Cambridge, MA: BioCanCell http://www.biocancell.com/lead-program/future-development-plan/ Accessed August 5, 2017
