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Find Clinical Drug Pipeline Developments & Deals for Arsenic Trioxide
INJECTABLE;INJECTION - 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 2MG/ML
BioSenic intends to use the net proceeds to prepare for an IND application with FDA for the Phase 3 clinical study with Arscimed, an oral arsenic trioxide (OATO) in the first-line treatment of chronic graft-versus-host disease (cGvHD).
The agreement aims for the development of the first oral formulation of ArsciCor (arsenic troxide) in the field of several targeted autoimmune diseases, including for cGvHD treatment.
The proceeds of the financing will essentially contribute to continuing to advance the clinical development of BioSenic’s lead asset, its ATO product, Arscimed (arsenic trioxide), in the treatment of chronic graft versus host disease (cGvHD).
ATO (arsenic trioxide) is administered daily by IV infusions, which is investigated for the treatment of Graft Versus Host Disease, Systemic Sclerosis, Systemic Lupus Erythematosus and infectious disease.
Under the license agreement, Medsenic agreed to commence a clinical study using Phebra's oral formulation OATO (arsenic trioxide) for the treatment of Graft Versus Host Disease, Systemic Sclerosis, Systemic Lupus Erythematosus and infectious diseases.
Arscimed® (arsenic trioxide), is a able to radically modify the autoimmune cascade and normalise the immune system without causing nonspecific immunosuppressionbeing studied for cGvHD.
The BioSenic autoimmune platform has been constructed to target systemic autoimmune diseases using arsenic trioxide (Arscimed, ATO). This uses ATO’s first-in-class mechanism of action as an active anti-inflammatory and immunomodulatory agent.
The acquisition of Medsenic and its specialized pipeline in the development of optimized formulations of arsenic trioxide (Arscimed) and their applications in serious inflammatory/autoimmune conditions and other potential new indications.
First-line combination of Arscimed (arsenic trioxide) and prednisone in cGvHD showed an Overall Response Rate (ORR) at 6 months of 75%, allowing rapid corticosteroid tapering.
The primary endpoint of this prospective, multicenter, non-randomized study was the improvement of treatment response with Arscimed® (arsenic trioxide) in combination with prednisone, with or without cyclosporine.