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A Phase III, Randomized, Double Blind, Dummy-Controlled Study of ThermoDox (Lyso-Thermosensitive Liposomal Doxorubicin-LTLD) in Hepatocellular Carcinoma (HCC) Using Standardized Radiofrequency Ablation (RFA) Treatment Time ≥ 45 Minutes for Solitary Lesions ≥ 3 cm to ≤ 7 cm

Trial Profile

A Phase III, Randomized, Double Blind, Dummy-Controlled Study of ThermoDox (Lyso-Thermosensitive Liposomal Doxorubicin-LTLD) in Hepatocellular Carcinoma (HCC) Using Standardized Radiofrequency Ablation (RFA) Treatment Time ≥ 45 Minutes for Solitary Lesions ≥ 3 cm to ≤ 7 cm

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Nov 2023

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At a glance

  • Drugs Doxorubicin liposomal (Primary) ; Dexamethasone; Diphenhydramine; Famotidine; Ranitidine
  • Indications Liver cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms OPTIMA
  • Sponsors Celsion Corporation; Imunon
  • Most Recent Events

    • 14 Nov 2023 According to an IMUNON media release, R&D expenses were $7.7 million for the first nine months of 2023 compared with $8.7 million for the comparable period in 2022. R&D costs to support the OVATION 2 Study as well as the Phase 3 OPTIMA Study decreased to $0.7 million for the first nine months of 2023 compared with $2.2 million for the comparable 2022 period.
    • 14 Nov 2023 According to an IMUNON media release, R&D expenses were $2.0 million for the third quarter of 2023 compared with $2.4 million for the comparable period in 2022. R&D costs to support the OVATION 2 Study as well as the Phase 3 OPTIMA Study decreased to $0.1 million for the third quarter of 2023 compared with $0.6 million for the same period of 2022.
    • 14 Nov 2023 According to an IMUNON media release, General and administrative expenses were $1.9 milion for the Q3 2023 compared with $3.9 million for the comparable prior-year period. The decrease was due to lower non-cash stock-compensation expense and lower professional fees in July 2020 of this study results, offset by higher compensation expenses related to the CEO succession plan announced in July 2022 and higher staffing costs.
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