Prostate Cancer Clinical Trial
A Phase Ib2, multicenter, randomized, double-blind, placebo-controlled safety and efficacy study evaluating different regimens of the immunotherapeutic drug, Mobilan (M-VM3), in patients with prostate cancer.
Mobilan is a nanoparticle-formulated, recombinant non-replicating adenovirus
immunotherapeutic drug that directs expression of both toll-like receptor 5 (TLR5) and a
specific agonistic ligand, entolimod (which is a recombinant form of the natural TLR5 ligand,
flagellin).
The viral construct infects cells expressing the Coxsackie virus and adenovirus receptor
(CAR), which has been shown in preclinical studies to be highly expressed in human prostatic
tissue, including prostate cancer tissue. Upon infection, co-expression of both receptor and
ligand in the same transfected cell triggers persistent autocrine stimulation of the nuclear
factor‑kappa B (NF‑κB) signaling cascade. In a syngeneic mouse prostate cancer model,
prostatic injection of Mobilan leads to activation of an innate immune response with
infiltration of neutrophils and natural killer cells (NK) cells and induction of an adaptive
immune response, comprising cytotoxic (cluster of differentiation [CD]8+) T cells. Necrotic
changes in tumor cells were observed in Mobilan-treated animals with concomitant reductions
in prostatic volume. Mobilan also show anti-metastatic activity in a surgical adjuvant mouse
model of prostate cancer.
This clinical trial is a Phase Ib double-blinded, randomized, placebo-controlled trial
evaluating the efficacy, safety, and pharmacology of either 1 or 2 injections of Mobilan or
placebo when administered as neoadjuvant therapy directly into the prostates of patients with
newly diagnosed prostate cancer.
All study subjects will receive 2 study drug injections administered 2 weeks apart and will
be randomly allocated in a 1:1:1 ratio to 1 of the following 3 drug administration schedules:
- Arm A: Mobilan on both Day 1 and on Day 15.
- Arm B: Placebo on Day 1 and Mobilan on Day 15.
- Arm C: Placebo on both Day 1 and Day 15 Subjects will subsequently undergo planned
prostatectomy, ideally within 2 weeks following the final study drug injection and will
remain under observation thereafter.
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