FDA places hold on Abeona late-stage study

Abeona Therapeutics announced that the FDA has placed a clinical hold on its planned Phase 3 clinical trial evaluating autologous cell therapy EB-101 in patients with recessive dystrophic epidermolysis bullosa.
Source: PharmaManufacturing.com - Category: Pharmaceuticals Source Type: news

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Abeona Therapeutics announced that the U.S. FDA has removed its clinical hold on the company ’s pivotal Phase 3 clinical trial evaluating gene therapy for the treatment of recessive dystrophic epidermolysis bullosa (RDEB).
Source: PharmaManufacturing.com - Category: Pharmaceuticals Source Type: news
Conclusion: The neonate was discharged with shorter hospitalization time and with total epithelization of the lesions, despite the severity. The family actively participated in the care process, demonstrating the ability to perform the dressings at home.
Source: Revista da Escola de Enfermagem da USP - Category: Nursing Source Type: research
Dystrophic epidermolysis bullosa (DEB) is a hereditary skin fragility disorder, characterized by trauma-induced blistering followed by soft tissue fibrosis. One of the most feared complications is the early de...
Source: Orphanet Journal of Rare Diseases - Category: Internal Medicine Authors: Tags: Letter to the Editor Source Type: research
The term epidermolysis bullosa (EB) comprises a number of rare and genetically heterogenous disorders characterized by structural skin fragility that results in recurrent blister formation.1 Dystrophic epidermolysis bullosa (DEB) is a subtype of EB that is caused by mutations in the COLA1 gene encoding type VII collagen; it is characterized by blister formation in the dermis, directly beneath the epidermis, and sometimes in the mucous membranes.2 The reported incidence of DEB is 26.4 new cases per 1,000,000 live births.
Source: Pediatrics and Neonatology - Category: Perinatology & Neonatology Authors: Tags: Short Communication Source Type: research
Authors: Zhang J, Ding Y, Li M, Yao Z, Zhuang Y Abstract Epidermolysis bullosa simplex, generalized severe (EBS-gen sev) is one of the major forms of EBS, caused by mutations of the keratin 5 (KRT5) or keratin 14 (KRT14). However, it is rarely reported in the Chinese population. The current study was performed on three unrelated Chinese families with five patients clinically suspicious for distinct stages of EBS. Mutation screening was performed by direct sequencing of the entire coding regions of KRT5 and KRT14 genes. A diagnosis of EBS-gen sev for patients in these three families was confirmed by revealing missen...
Source: Experimental and Therapeutic Medicine - Category: General Medicine Tags: Exp Ther Med Source Type: research
Recessive dystrophic epidermolysis bullosa (RDEB) is a hereditary blistering disorder due to lack of type VII collagen (C7). At present, treatment is mainly supportive.
Source: Journal of the American Academy of Dermatology - Category: Dermatology Authors: Source Type: research
PMID: 31773727 [PubMed - as supplied by publisher]
Source: The British Journal of Dermatology - Category: Dermatology Authors: Tags: Br J Dermatol Source Type: research
Condition:   Recessive Dystrophic Epidermolysis Bullosa Interventions:   Drug: Rigosertib Sodium;   Other: Quality-of-Life Assessment Sponsors:   Thomas Jefferson University;   Onconova Therapeutics, Inc. Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
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