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概览

关联

1

项与 Panacela Labs LLC 相关的药物

Mobilan

靶点

TLR5

作用机制

TLR5激动剂

在研机构

Roswell Park Comprehensive Cancer Center [+3]

原研机构

The Cleveland Clinic Foundation

在研适应症

前列腺癌

非在研适应症-

最高研发阶段临床2期

首次获批国家/地区-

首次获批日期-

2

项与 Panacela Labs LLC 相关的临床试验

NCT02844699 / Unknown status临床1/2期

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

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.

开始日期2016-07-01

申办/合作机构

Panacela Labs LLC

NCT02654938 / Completed临床1期

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

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.

开始日期2015-07-01

申办/合作机构

Panacela Labs LLC

100 项与 Panacela Labs LLC 相关的临床结果

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0 项与 Panacela Labs LLC 相关的专利（医药）

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3

项与 Panacela Labs LLC 相关的文献（医药）

2020-04-07·Oncotarget

First-in-human study of anticancer immunotherapy drug candidate mobilan: safety, pharmacokinetics and pharmacodynamics in prostate cancer patients

Article

作者: Kazey, Vasily I. ; Leonenkov, Roman V. ; Mett, Vadim L. ; Pushkar, Dmitry Y. ; Eremina, Natalia V. ; Mishugin, Sergey V. ; Gudkov, Andrei V.

Toll-like receptor 5 (TLR5) controls endogenous immune responses to pathogens and is a promising target for pharmacological stimulation of anti-tumor immunity. Mobilan is an innovative gene therapy agent consisting of a non-replicating bicistronic adenovirus directing constitutive expression of human Toll-like receptor 5 (TLR5) and the secreted flagellin-based TLR5 agonist, 502s. In mice, Mobilan injection into prostate tumors resulted in autocrine TLR5 signaling, immune system activation, and suppression of tumor growth and metastasis. Here we report a first-in-human placebo-controlled clinical study of Mobilan aimed at evaluating safety, tolerability, pharmacokinetics and pharmacodynamics of a single intra-prostate injection of Mobilan in early stage prostate cancer patients. Mobilan was safe and well-tolerated at all tested doses; thus, the maximum tolerated dose was not identified. Injection of Mobilan induced signs of self-resolving inflammation not present in placebo-injected patients, including transient elevation of PSA and cytokine (G-CSF, IL-6) levels, and increased lymphoid infiltration in prostate tissue. The highest dose of Mobilan (10¹¹ viral particles) produced the best combination of safety and pharmacodynamic effects. Therefore, Mobilan is well-tolerated and induces the expected pharmacodynamic response in humans. These results support further clinical development of Mobilan as a novel immunotherapy for prostate cancer.

2017-04-01·Mutation Research/Genetic Toxicology and Environmental Mutagenesis3区 · 医学

Genotoxicity of two new carbazole derivatives with antifungal activity

3区 · 医学

Article

作者: Durnev, Andrey D ; Eremina, Natalya V ; Kazey, Vasily I ; Chayka, Zlata V ; Zhanataev, Aliy K ; Purmal, Andrei A ; Rydkina, Elena B ; Andrianova, Ekaterina L

The class of carbazoles includes compounds with high biological activities and broad spectra of action. PLX01107 and PLX01008 are xenomycins, a new subclass of antimicrobial carbazole derivatives demonstrating strong antifungal activity in vitro. We performed three tests, a bacterial reverse mutation assay (Ames test), in vitro cytokinesis-block micronucleus assay, and chromosome aberration test in mouse bone marrow cells, to investigate the possible genotoxicity of these compounds. Despite their structural similarity, the two compounds had different genotoxicity profiles. PLX01008 showed positive effects in all assays. PLX01107 showed no mutagenicity in the Ames test but demonstrated strong cytogenetic activity in vitro and in vivo. PLX01107 was also tested in the in vivo alkaline comet assay, where a weak but statistically significant increase in DNA damage was seen in liver cells 24h after treatment. Significantly increased levels of formamidopyrimidine DNA glycosylase (FPG)-sensitive sites were found in bone marrow cells of PLX01107-treated mice (FPG-modified comet assay), suggesting induction of oxidative or alkylation damage to DNA.

Eksperimental'naya i Klinicheskaya Farmakologiya

Preclinical toxicological investigation of drugs based on adenovirus particles: antitumor vaccine Mobilan (M-VM3)

作者: Zhanataev, A. K. ; Eremina, N. V. ; Sorokina, A. V. ; Durnev, A. D. ; Nemova, E. P. ; Kovalenko, L. P. ; Mett, V. L. ; Kazei, V. I. ; Alekseeva, S. V.

Mobilan (M-VM3) is an innovative gene therapy agent based on the non-replicating adenovirus system to deliver the vector coding for TL-receptor proteins and the corresponding protein 502s ligand of this receptor, which has been designed for the immunotherapy of prostate cancer.A standard set of preclin. safety studies for this drug included toxicity studies with a single (acute toxicity) and multiple (chronic toxicity) administration in two species of animals, mutagenic activity, immunotoxicity, allergenicity, and reproductive toxicity.The results of toxicol. studies did not reveal factors hindering the clin. trials of Mobilan (M-VM3), however, when planning this stage, it is necessary to consider its potential risks for patients with bleeding disorders or suffering from chronic inflammatory diseases.

100 项与 Panacela Labs LLC 相关的药物交易

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100 项与 Panacela Labs LLC 相关的转化医学

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