A Double, Blind Placebo-controlled, Randomized Trial to Study Efficacy and Safety of the Viaskin Milk for Treating Milk Induced Eosinophilic Esophagitis in Children

This is a single-site, double-blind, placebo-controlled, randomized trial to study efficacy and safety of the Viaskin® Milk Patch for children with milk induced Eosinophilic Esophagitis (EoE). 20 subjects will be randomized 3:1 to Viaskin® Milk or placebo patch.

开始日期2015-10-01

申办/合作机构

The Children's Hospital of Philadelphia

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100 项与 DBV-135 相关的专利（医药）

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项与 DBV-135 相关的文献（医药）

2020-02-01·Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association1区 · 医学

Efficacy of Epicutaneous Immunotherapy in Children With Milk-Induced Eosinophilic Esophagitis.

1区 · 医学

Article

作者: Jonathan M Spergel ; Okan U Elci ; Amanda B Muir ; Chris A Liacouras ; Benjamin J Wilkins ; Deirdre Burke ; Megan O Lewis ; Terri Brown-Whitehorn ; Antonella Cianferoni

BACKGROUND & AIMS:

Eosinophilic esophagitis (EoE) is caused by an immune response to specific food allergens. There are no approved therapies beyond avoidance of the allergen(s) or treatment of inflammation. Epicutaneous immunotherapy (EPIT) reduces features of eosinophilic gastrointestinal disease in mice and pigs. We performed randomized, placebo-controlled study to determine the safety and efficacy of EPIT with Viaskin milk in children with milk-induced EoE.

METHODS:

In a double-blind study, 20 children (4-17 years old) with milk-induced EoE were randomly assigned to groups given EPIT with Viaskin milk (n = 15) or placebo (n = 5) for 9 months during a milk-free period, followed by milk-containing diet for 2 months with EPIT. Then, subjects underwent upper endoscopy analysis, biopsies were collected, and maximum esophageal eosinophil counts were determined and was the primary endpoint. After upper endoscopy, patients were given open-label EPIT for 11 months (open-label phase). The subjects were allowed to consume milk if they had maximum values of fewer than 10 eosinophils/high-power field (eos/hpf); otherwise, they remained on a milk-free diet until the last 2 months of the open-label phase.

RESULTS:

In the intent to treat population, there was no significant difference between the Viaskin milk group in mean eos/hpf (50.1 ± 43.97 eos/hpf) vs the placebo group (48.20 ± 56.98 eos/hpf). However, in the per-protocol population (7 patients given Viaskin milk and 2 patients given placebo), patients given Viaskin milk patients had a significantly lower mean eos/hpf count (25.57 ± 31.19) than patients given placebo (95.00 ± 63.64) (p = .038). At the end of the open-label phase, 9 of 19 evaluable subjects had mean values of fewer than 15 eos/hpf (47% response). The number of adverse events did not differ significantly between the Viaskin milk and placebo groups; there was 1 serious adverse event in the placebo group.

CONCLUSIONS:

In a pilot study of pediatric patients with EoE given EPIT with Viaskin milk or placebo for 11 months, we found no significant difference between groups for the maximum eosinophil count at the end of the study. However, findings from a per-protocol analysis indicate that Viaskin milk can reduce eos/hpf. At study completion, 47% of patients who continued open-label Viaskin milk for an additional 11 months had mean values of fewer than 15 eos/hpf. ClinicalTrials.gov no: NCT02579876.

2016-12-10·Journal of controlled release : official journal of the Controlled Release Society1区 · 医学

Non-invasive epicutaneous vaccine against Respiratory Syncytial Virus: Preclinical proof of concept.

1区 · 医学

Article

作者: Pierre-Louis Hervé ; Delphyne Descamps ; Charlotte Deloizy ; Véronique Dhelft ; Daphné Laubreton ; Edwige Bouguyon ; Abdelhak Boukadiri ; Catherine Dubuquoy ; Thibaut Larcher ; Pierre-Henri Benhamou ; Jean-François Eléouët ; Nicolas Bertho ; Lucie Mondoulet ; Sabine Riffault

To put a Respiratory Syncytial Virus (RSV) vaccine onto the market, new vaccination strategies combining scientific and technical innovations need to be explored. Such a vaccine would also need to be adapted to the vaccination of young children that are the principal victims of acute RSV infection. In the present project, we describe the development and the preclinical evaluation of an original epicutaneous RSV vaccine that combines two technologies: Viaskin® epicutaneous patches as a delivery platform and RSV N-nanorings (N) as a subunit antigen. Such a needle-free vaccine may have a better acceptability for the vaccination of sensible population such as infants since it does not require any skin preparation. Moreover, this self-applicative vaccine would overcome some issues associated to injectable vaccines such as the requirement of sterile medical devices, the need of skilled health-care professionals and the necessity of stringent store conditions. Here, we demonstrate that Viaskin® patches loaded with a formulation containing N-nanorings (Viaskin®-N) are highly immunogenic in mice and promotes a Th1/Th17 oriented immune response. More importantly, Viaskin®-N epicutaneous vaccine confers a high level of protection against viral replication upon RSV challenge in mice, without exacerbating clinical symptoms. In swine, which provides the best experimental model for the transcutaneous passage of drug/antigen in human skin, we have shown that GFP fluorescent N-nanorings, delivered epicutaneously with Viaskin® patches, are taken up by epidermal Langerhans cells. We have also demonstrated that Viaskin®-N induced a significant RSV N-specific T-cell response in pig. In conclusion, Viaskin®-N epicutaneous vaccine seems efficient to protect against RSV infection in animal model.

2011-02-28·International Journal of Pharmaceutics2区 · 医学

Evaluation of a multi-functional nanocarrier for targeted breast cancer iNOS gene therapy

2区 · 医学

Article

作者: McCarthy, Helen O. ; Zholobenko, Alek V. ; Wang, Yuhua ; Canine, Brenda ; Robson, Tracy ; Hirst, David G. ; Hatefi, Arash

The present study determines whether the novel designer biomimetic vector (DBV) can condense and deliver the cytotoxic iNOS gene to breast cancer cells to achieve a therapeutic effect. We have previously shown the benefits of iNOS for cancer gene therapy but the stumbling block to future development has been the delivery system. The DBV was expressed, purified and complexed with the iNOS gene. The particle size and charge were determined via dynamic light scattering techniques. The toxicity of the DBV/iNOS nanoparticles was quantified using the cell toxicity and clonogenic assays. Over expression of iNOS was confirmed via Western blotting and Griess test. The DBV delivery system fully condensed the iNOS gene with nanoparticles less than 100nm. Transfection with the DBV/iNOS nanoparticles resulted in a maximum of 62% cell killing and less than 20% clonogenicity. INOS overexpression was confirmed and total nitrite levels were in the range of 18μM. We report for the first time that the DBV can successfully deliver iNOS and achieve a therapeutic effect. There is significant cytotoxicity coupled with evidence of a bystander effect. We conclude that the success of the DBV fusion protein in the delivery of iNOS in vitro is worthy of future in vivo experiments.

项与 DBV-135 相关的新闻（医药）

2024-03-08

·FierceBiotech

Food allergy biotech DBV is running out of cash, with phase 3 trials underway

DBV Technologies hopes to complete enrollment in two supplemental safety trials of a peanut allergy therapy this year. DBV Technologies, a French biotech working on a treatment for food allergies, says it's running out of cash. The disclosure came via a going concern note in the company’s fourth-quarter and full-year 2023 earnings report on Friday, with DBV saying it doesn’t have enough money to keep the lights on for a full 12 months. DBV says it has until the very end of the year based on the $141.4 million in cash reported as of the end of December 2023. To persevere, the biotech will look to raise more money via debt and equity offerings. DBV’s cash reserves fell by nearly $68 million in 2023, with most of the money going toward R&D. Much of the biotech’s focus centers on lead peanut allergy treatment DBV712, with two phase 3 safety trials ongoing in kids. The goal is to complete enrollment in two supplemental six-month safety trials this year, despite experiencing delays that were attributed to new clinical trial rules in Europe. “We expect good momentum regarding Vitesse recruitment in the next several months and last subject screened by Q3 2024,” DBV CEO Daniel Tassé said in a release. The late-stage development work makes DBV’s current cash crunch all the more perilous, given how close the company potentially is to the market. In addition to wrapping up enrollment in the two COMFORT trials, DBV expects to have three-year data from an efficacy trial in toddlers 1-3 years old. A sibling trial for kids 4-7 years old is slated to screen its last patient by the third quarter of 2024. That study, named VITESSE, was previously on an FDA partial hold while the company and regulators worked on an updated trial protocol. Should DBV strengthen its balance sheet, there are two additional phase 2 trials waiting in the wings for runner-up med DBV135, which is in development for milk allergies and eosinophilic esophagitis.

临床3期临床2期

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研发状态

适应症	最高研发状态	国家/地区	公司
嗜酸粒细胞性食管炎	临床2期	美国更多	DBV Technologies SA 更多
食物过敏	临床2期	美国更多	DBV Technologies SA 更多
牛奶过敏反应	临床2期	美国更多	DBV Technologies SA 更多

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临床结果

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分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02579876 (CTgov)	临床2期	牛奶过敏反应 \| 嗜酸粒细胞性食管炎	20	Viaskin Milk 500 mcg (Viaskin Milk 500 mcg)	範餘繭遞廠蓋壓廠鑰蓋(鹹構窪積鹹範蓋構艱範) = 製鬱壓積醖壓夢獵簾選範鑰夢壓衊蓋齋餘鹹蓋 (糧壓願餘壓鏇構衊鑰壓, 齋壓獵鏇壓壓窪鬱繭觸 ~ 蓋願淵鬱艱夢鹽選遞遞) 更多	-	2019-07-10
				Viaskin Placebo (Viaskin Placebo)	範餘繭遞廠蓋壓廠鑰蓋(鹹構窪積鹹範蓋構艱範) = 蓋構憲鬱繭顧膚繭襯襯範鑰夢壓衊蓋齋餘鹹蓋 (糧壓願餘壓鏇構衊鑰壓, 廠願網繭築淵繭廠鏇襯 ~ 夢鏇選壓繭願觸構齋鹹) 更多