Collategene (beperminogene perplasmid) / AnGes MG, Mitsubishi Tanabe, Kamada, Er-Kim Pharma - LARVOL DELTA

Anatomically Directed Lower Extremity Gene Therapy for Ulcer Healing: A Double-Blind, Randomized, Placebo-Controlled Study (LEGenD-1). (PubMed, Circ Cardiovasc Interv) - P2 | "Anatomically targeted intramuscular delivery of AMG0001 significantly accelerated healing in patients with moderate chronic limb-threatening ischemia and neuroischemic ulcers and may represent a promising nonsurgical therapeutic strategy. URL: https://www.clinicaltrials.gov; Unique identifier: NCT04267640."

Journal • Cardiovascular • Diabetes • Gene Therapies • Metabolic Disorders • Peripheral Arterial Disease • HGF

HGF gene therapy- Phase II data in USA, and FDA approved Breakthrough therapy (ASGCT 2025) - "Based on phase III data, HGF gene therapy drug, Collategene, has been approved by PMDA in Japan...Now, Collategens was approved by Breakthrough Therapy by FDA. In this session, we would like to discuss about future application of HGF gene therapy."

Gene therapy • P2 data • Cardiovascular • Gene Therapies • Peripheral Arterial Disease • HGF

Dark Clouds Looming Over Regenerative Medicine in Japan. (PubMed, Stem Cells Dev) - "Japan's regenerative medicine sector has encountered major challenges, underscored by the recent failures of products such as HeartSheet and Collategene. These setbacks expose critical weaknesses in the fast-track approval system, raising concerns about patient safety and the scientific robustness of product evaluations. Despite strong governmental support, addressing these fundamental issues is essential for the future success of regenerative medicine in Japan."

Journal

Anatomically Directed Lower Extremity Gene Therapy for Ulcer Healing: A Double Blind, Randomized, Placebo Controlled Study (AHA 2024) - "Adverse events were evenly distributed.ConclusionsAnatomically directed delivery of AMG0001 is well-tolerated and significantly improved time to complete healing in people with moderate CLTI and concomitant neuroischemic ulcers. HGF gene transfer may offer a promising alternative for the treatment of patients with CLTI."

Clinical • Gene therapy • Cardiovascular • Gene Therapies • Peripheral Arterial Disease • HGF

704/DNA vaccines leverage cytoplasmic DNA stimulation to promote anti-HIV neutralizing antibody production in mice and strong immune response against alpha-fetoprotein in non-human primates. (PubMed, Mol Ther Nucleic Acids) - "DNA-based gene therapies and vaccines have the potential for rapid development, as exemplified by the recent approval of Collategene, a gene therapy to treat human critical limb ischemia, and ZyCoV, a DNA vaccine delivered by spring-powered jet injector to protect against SARS-CoV2 infection...An investigation of the underlying mechanisms showed that 704-mediated vaccination did trigger a strong immune response by (1) allowing a direct DNA delivery into the cytosol, (2) promoting an intracytoplasmic DNA sensing leading to both interferon and NF-κB cascade stimulation, and (3) inducing antigen expression by muscle cells and presentation by antigen-presenting cells, leading to the induction of a robust adaptive response. Overall, our findings suggest that the 704-mediated DNA vaccination platform is an attractive method to develop both prophylactic and therapeutic vaccines."

Journal • Preclinical • Cardiovascular • Gastrointestinal Cancer • Gene Therapies • Hepatocellular Cancer • Human Immunodeficiency Virus • Infectious Disease • Novel Coronavirus Disease • Oncology • Peripheral Arterial Disease • Respiratory Diseases • Solid Tumor • AFP • NFKB1 • NF-κβ

Angiographic Change After Injection of Beperminogene Perplasmid, a Hepatocyte Growth Factor Gene Therapy Product for the Treatment of Critical Limb Ischemia. (PubMed, Circ Rep) - No abstract available

Journal • Gene Therapies • Peripheral Arterial Disease • HGF

"AnGes and Er-Kim Enter Into an Agreement for the Commercialization of Collategene® in Turkey https://t.co/6xgW3fKV9F" (@NewsFromBW)

AGILITY: Efficacy and Safety of AMG0001 in Subjects With Critical Limb Ischemia (clinicaltrials.gov) - P3; N=46; Terminated; Sponsor: AnGes; Trial primary completion date: Feb 2019 ➔ Mar 2017

Trial primary completion date • Biosimilar • Gene Therapies • Reperfusion Injury

A Long Term Follow-up Study of AMG0001 in Subjects With Critical Limb Ischemia (clinicaltrials.gov) - P=N/A; N=9; Completed; Sponsor: AnGes USA, Inc.; Active, not recruiting ➔ Completed; Trial completion date: Jul 2019 ➔ Jan 2020; Trial primary completion date: Jul 2019 ➔ Jan 2020

Clinical • Trial completion • Trial completion date • Trial primary completion date

Study of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects With Peripheral Ischemic Ulcers (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: AnGes USA, Inc.

Clinical • New P2 trial