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Donaperminogene seltoplasmid - Helixmith

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Drug Profile

Donaperminogene seltoplasmid - Helixmith

Alternative Names: Donaperminogene seltoplasmid; Engensis; Hepatocyte growth factor gene therapy-Helixmith; HGF plasmid; Modified hepatocyte growth factor gene therapy-Helixmith; NL003; pCK-HGF-X7; VM-202; VM202-ALS; VM202-CAD; VM202-DPN; VM202-PAD; VM202-Stent; VM202RY

Latest Information Update: 31 Mar 2025

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At a glance

  • Originator ViroMed Co Ltd
  • Developer Beijing Northland Biotech; Helixmith; Reyon Pharmaceutical
  • Class Anti-ischaemics; Foot disorder therapies; Gene therapies; Neuroprotectants; Skin disorder therapies; Vascular disorder therapies
  • Mechanism of Action Angiogenesis inducing agents; Gene transference; Hepatocyte growth factor expression stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Amyotrophic lateral sclerosis
  • New Molecular Entity No

Highest Development Phases

  • Phase III Chronic limb-threatening ischemia; Diabetic foot ulcer; Diabetic neuropathies
  • Phase II Amyotrophic lateral sclerosis; Coronary artery disease; Myocardial infarction
  • Phase I/II Charcot-Marie-Tooth disease
  • No development reported Ischaemic heart disorders; Myocardial ischaemia

Most Recent Events

  • 25 Mar 2025 Helixmith withdrew a phase-II trial in Myocardial infarction in South Korea (Intracardiac), deciding not to proceed with the study (NCT03404024)
  • 31 Jul 2024 Helixmith completes phase III REGAiN-1A trial for Diabetic neuropathies in USA (IM) (NCT04469270)
  • 23 Jul 2024 Helixmith completes a phase III REGAiN-1B extension study for Diabetic neuropathies in USA (IM, Injection)(NCT04873232)

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