A 6-Month Extension Study to Assess the Long-Term Safety of Engensis in Amyotrophic Lateral Sclerosis

NCTID	NCT05176093 (View at clinicaltrials.gov)
Description	The purpose of this study is to evaluate the long-term safety of intramuscular (IM) administration of Engensis in Participants with Amyotrophic Lateral Sclerosis (ALS) who were previously randomized, received treatment, and completed the Day 180 Visit of Study VMALS-002-2. Safety will be assessed by incidences of treatment-emergent adverse events (TEAEs), treatment emergent serious adverse events (TESAEs), adverse events of special interest (AESIs), and the clinically significant laboratory values. See the table below for additional, exploratory endpoints. (Show More)
Development Status	Active
Indication	Amyotrophic Lateral Sclerosis
Disease Ontology Term	DOID:332
Compound Name	ENGENSIS
Compound Alias	donaperminogene seltoplasmid, VM202
Compound Description	pCK-HGF-X7 (HGF 728, HGF723 isoforms)
Sponsor	Helixmith Co., Ltd.
Funder Type	Industry
Recruitment Status	Completed
Enrollment Count	8
Results Posted	Not Available

Target Gene/Variant	HGF
Therapy Type	Gene transfer
Therapy Route	In-vivo
Mechanism of Action	Overexpression of protective allele/gene
Route of Administration	Intramuscular
Drug Product Type	Plasmid
Target Tissue/Cell
Delivery System	None (naked plasmid)
Vector Type
Editor Type
Dose 1	64mg/cycle, 3 cycles/patient, 2 days/cycle, 128 injections/cycle
Dose 2
Dose 3
Dose 4
Dose 5

No.of Trial Sites	2
Locations	United States,Korea, Republic of