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Immunomodulating Agents

Patients with histologically verified non-metastatic prostate cancer (stage 1 or 2) treated with Investigational Drug Product

Patients with histologically verified non-metastatic prostate cancer (stage 1 or 2) treated with Placebo (Glucose 5%)

Mobilan (M-VM3), innovative experimental drug based on non-replicate adenoviral delivery system consisting genomic vector coding TLR5-receptor and its ligand 502s.

Mobilan (M-VM3)

Placebo

Vsevolod B. Matveev, MD, PhD

Boris Y. Alexeev, MD, PhD

Vladimir M. Moiseenko, MD, PhD

Sergey V. Mishugin, MD, PhD

Alexander K. Nosov, MD, PhD

Dmitry Y. Pushkar, MD, PhD

Phase I single-blinded, randomized, placebo-controlled trial evaluating safety, tolerability, pharmacokinetics and pharmacodynamics of single injections of ascending doses of investigational drug product Mobilan (М-VM3) administered directly into the prostate of patients with prostate cancer.

Mobilan is a type V adenovirus carrying TLR5 receptor and its agonist, protein 502s. It's mechanism of action involves activation of immune system and extensive mobilisation of various immunocytes to administration locus. It's safety and tolerability is currently evaluated in first-in-man phase I study in prostate cancer patients. Treatment strategy for the disease (radical prostatectomy or active observation) will be determined by the Investigator in accordance with routine clinical practice of the hospital.

Patients will be randomised in cohorts of 4 subjects, where 3 subjects will be administered with Mobilan (М-VM3), and one patient will be administered with placebo.

The dose will be escalated from cohort to cohort, the decision on possible dose escalation will be made by Independent Safety Review Board.

Safety and Tolerability Clinical Trial of Different Doses of the Immunotherapeutic Drug Mobilan (M-VM3) and Placebo in Patients With Prostate Cancer

Multicenter, Randomized, Single-blind Safety and Tolerability Clinical Trial of Different Doses of the Immunotherapeutic Drug Mobilan (M-VM3) and Placebo in Patients With Prostate Cancer

Baseline PSA level will be taken from medical history

Including leucocytes, lymphocytes, T-lymphocyte, leukocyte index, total T-lymphocytes, CD3, T-helper cells CD3 + CD4 +, T-cytotoxic CD3 + CD8 +, regulation index (CD4 / CD8), double-cells CD4 + / CD8 +, NK cells CD3-CD (16 + 56) +, TNK-cells CD3 + CD (16 +56) +, B-lymphocytes CD19 +, 0-lymphocytes

The Gleason grading system is used to evaluate the stage of prostate cancer using samples from biopsy or post-surgical samples as follow:

1 - The cancerous prostate closely resembles normal prostate tissue. 2 - The tissue still has well-formed glands, but they are larger and have more tissue between them. 3 - The tissue still has recognizable glands, but the cells are darker. 4 - The tissue has few recognizable glands. 5 - The tissue does not have any or only a few recognizable glands.

Irani J (1997) scale include histological assessment of slide mounts obtained after operation as follow:

Degree of immune cell infiltration:

0 - No inflammatory cells, 1 - Scattered inflammatory cell infiltrate within the stroma without lymphoid nodules, 2 - Nonconfluent lymphoid nodules, 3 - Large inflammatory areas with confluence of infiltrate

Panacela Labs LLC

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

One subcutaneous injection of CBLB502 0.35 μg/kg (not more 30 μg/injection) or Placebo at Day 1 before tumor removal

One subcutaneous injection of CBLB502 0.45 μg/kg (not more 40 μg /injection) or Placebo at Day 1 before tumor removal

Two subcutaneous injections of CBLB502 0.35 μg/kg (not more 30 μg/injection) or Placebo at Day 1 and Day 4 before tumor removal

Two subcutaneous injections of CBLB502 at 0.45 μg/kg (not more 40 μg /injection) or Placebo at Day 1 and Day 4 before tumor removal

CBLB502

Sergei I. Achkasov, MD PhD

Nikolay V. Kislov, MD PhD

Sergei V. Odintcov, MD PhD

Randomized Single-blind Placebo-controlled Clinical Study of Safety and Tolerability of CBLB502 as a Neo-adjuvant Treatment in Patients With Colorectal Cancer, With Different Doses and Regimens

Clinical Study of Safety and Tolerability of CBLB502 as a Neo-adjuvant Treatment in Patients With Colorectal Cancer

Cleveland BioLabs, Inc.

BioLab 612 LLC

Patients with histologically verified non-metastatic prostate cancer (stage 1 or 3) treated with Investigational Drug Product (Mobilan (M-VM3)) administered 2 weeks apart. All subjects will subsequently undergo planned prostatectomy, ideally within 2 weeks following the final study drug injection and will remain under observation thereafter.

Patients with histologically verified non-metastatic prostate cancer (stage 1 or 3) treated with Placebo (Glucose 5%) first on Day 1 and Investigational Drug Product (Mobilan (M-VM3)) in two weeks on Day 15. All subjects will subsequently undergo planned prostatectomy, ideally within 2 weeks following the final study drug injection and will remain under observation thereafter.

Patients with histologically verified non-metastatic prostate cancer (stage 1 or 3) treated with Placebo (Glucose 5%) administered 2 weeks apart. All subjects will subsequently undergo planned prostatectomy, ideally within 2 weeks following the final study drug injection and will remain under observation thereafter.

5% infusion solution of dextrose (glucose)

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.

A Multicenter Randomized Double-blind Placebo-controlled Pilot Study of Safety, Pharmacodynamics and Efficacy of Different Treatments of Immunotherapeutic Drug Mobilan (M-VM3) in Patients With Diagnosed Prostate Cancer

The Gleason grading system is used to evaluate the stage of prostate cancer using samples from biopsy or post- surgical samples as follow:

1 - The cancerous prostate closely resembles normal prostate tissue. 2 - The tissue still has well-formed glands, but they are larger and have more tissue between them. 3 - The tissue still has recognizable glands, but the cells are darker. 4 - The tissue has few recognizable glands. 5 - The tissue does not have any or only a few recognizable glands.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Tolerability Clinical Trial of Different Doses of the Immunotherapeutic Drug Mobilan (M-VM3) and Placebo in Patients With Prostate Cancer	NCT02654938	Prostate Cancer	Mobilan (M-VM3) Placebo	45 Years - 75 Years	Panacela Labs LLC
Clinical Study of Safety and Tolerability of CBLB502 as a Neo-adjuvant Treatment in Patients With Colorectal Cancer	NCT02715882	Colorectal Canc...	CBLB502 Placebo	18 Years -	BioLab 612 LLC
A Multicenter Randomized Double-blind Placebo-controlled Pilot Study of Safety, Pharmacodynamics and Efficacy of Different Treatments of Immunotherapeutic Drug Mobilan (M-VM3) in Patients With Diagnosed Prostate Cancer	NCT02844699	Prostate Cancer	Mobilan (M-VM3) Placebo	45 Years - 75 Years	Panacela Labs LLC
Safety and Tolerability Clinical Trial of Different Doses of the Immunotherapeutic Drug Mobilan (M-VM3) and Placebo in Patients With Prostate Cancer	NCT02654938	Prostate Cancer	Mobilan (M-VM3) Placebo	45 Years - 75 Years	Panacela Labs LLC
Safety and Tolerability Clinical Trial of Different Doses of the Immunotherapeutic Drug Mobilan (M-VM3) and Placebo in Patients With Prostate Cancer	NCT02654938	Prostate Cancer	Mobilan (M-VM3) Placebo	45 Years - 75 Years	Panacela Labs LLC
A Multicenter Randomized Double-blind Placebo-controlled Pilot Study of Safety, Pharmacodynamics and Efficacy of Different Treatments of Immunotherapeutic Drug Mobilan (M-VM3) in Patients With Diagnosed Prostate Cancer	NCT02844699	Prostate Cancer	Mobilan (M-VM3) Placebo	45 Years - 75 Years	Panacela Labs LLC

Spots Global Cancer Trial Database for tlr5

Every month we try and update this database with for tlr5 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tlr5

Every month we try and update this database with for tlr5 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tlr5 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.