Arscimed (arsenic trioxide) / BioSenic - LARVOL DELTA

BioSenic provides third quarter 2024 Business Update (GlobeNewswire) - "A Phase III study with oral arsenic trioxide in the first-line treatment of cGvHD, for which Medsenic received positive pre-IND response from the FDA, is currently anticipated to start in 2024....Phase IIb clinical trials for SLE and SSc are in the planning stage with the protocols for both studies being ready....The start of SLE and SSc Phase II clinical trials is therefore not envisioned before 2025."

New P2b trial • New P3 trial • Chronic Graft versus Host Disease • Systemic Lupus Erythematosus • Systemic Sclerosis

Medsenic/BioSenic patent granted in Japan for more protection of its therapeutic platform (GlobeNewswire) - "BioSenic...today announces the granting of a key patent by the Japan Patent Office to expand protection of the arsenic trioxide (ATO) platform. The patent, titled 'Use of metal ions to potentiate the therapeutic effects of arsenic,' covers the use of ATO platform in combination with metal ions such as copper....The new patent, granted to BioSenic’s subsidiary company Medsenic, involves two main immediate areas of application. The first one is in immune- and autoimmune-related diseases – specifically, the BioSenic’s lead project in 2024, chronic GvHD and, later, systemic sclerosis and systemic lupus erythematosus."

Patent • Chronic Graft versus Host Disease • Systemic Lupus Erythematosus • Systemic Sclerosis

Medsenic receives the intention to grant a key European patent from EPO, valuable for the therapeutic development of arsenic trioxide in relapsing-remitting multiple sclerosis (GlobeNewswire) - "BioSenic...announces that the European Patent Office (EPO) has granted an important new EU patent to its subsidiary Medsenic entitled: METHOD FOR TREATING RELAPSING-REMITTING MULTIPLE SCLEROSIS USING ARSENIC TRIOXIDE (EP18722530, priority date May 4, 2018)....The expected EU patent allows the specific application of Medsenic's arsenic platform to the key human health indication, Multiple Sclerosis."

Patent • Immunology • Systemic Sclerosis

BioSenic reports half year 2023 results (GlobeNewswire) - "The Medsenic Phase 2 clinical study with arsenic trioxide in the first-line treatment of cGvHD has been completed and provided positive results. A Phase 3 study with oral arsenic trioxide in the first-line treatment of cGvHD, for which Medsenic received positive pre-IND response from the FDA, is currently anticipated to start in 2024."

New P3 trial • Chronic Graft versus Host Disease

BioSenic to draw the final tranches of its present Global Tech Opportunities 15 convertible bonds program and secure runway end of January 2024 (GlobeNewswire) - "BIOSENIC...today announces that it has reached a definitive agreement with Global Tech Opportunities 15 (GTO15) with respect to the finalization of the existing convertible bonds program....GTO15 will fund two tranches of EUR 300,000 each (minus a commission of 10%) of the existing convertible bonds program...BioSenic anticipates having sufficient cash to carry out its business objectives until the end of January 2024....BioSenic is now focusing its efforts in organizing a fundraising event to allow the initiation of its phase 3 clinical trial with arsenic trioxide (ATO) to treat chronic graft versus host disease (cGVHD). The initiation is currently scheduled for Q2 2024....Under the terms of the present agreement, GTO15 agrees to voluntarily withdraw its latest conversion notice for EUR 1,400,000, that would have led to an issuance of 58 million of shares."

Licensing / partnership • New P3 trial • Chronic Graft versus Host Disease

BioSenic releases details of optimized administration approach ahead of planned Phase 3 trial of OATO for chronic graft-versus-host disease (GlobeNewswire) - P2 | N=21 | GvHD-ATO (NCT02966301) | Sponsor: Medsenic | "BIOSENIC...announces the publication of an open-access article describing an optimized schedule for administration of oral arsenic trioxide (OATO) treatment for chronic graft-versus-host disease (cGvHD), based on an earlier post-hoc analysis of Phase 2 data. The schedule will play an important role in the protocol for BioSenic’s forthcoming pivotal Phase 3 clinical trial....It shows that the risk of loss of overall response over time is greater in patients who received only one cycle of ATO since they are in partial or complete remission at week 6 post-treatment compared to patients who received two cycles of second-line treatment. The use of 2 cycles of 4 weeks each, separated by a rest period of 4 weeks on ATO at 0.15mg/kg/day, should be optimal for the future treatment of cGvHD patients."

New P3 trial • P2 data • Chronic Graft versus Host Disease

BioSenic presents successful preclinical data on its ATO medication for controlling key symptoms at the 2024 Systemic Sclerosis World Congress (GlobeNewswire) - "BioSenic...presented the latest data on arsenic trioxide (ATO) for systemic sclerosis (SSc) at the 8th Systemic Sclerosis World Congress 2024. The data, obtained with the laboratory of Yannick Allanore, MD, Ph.D...builds additional evidence for the use of ATO in multiple autoimmune conditions, as observed in various animal models and in recent pilot human clinical trials."

Preclinical • Immunology • Systemic Sclerosis

BioSenic presents successful preclinical data on its ATO medication for controlling key symptoms at the 2024 Systemic Sclerosis World Congress (GlobeNewswire) - "BioSenic...presented the latest data on arsenic trioxide (ATO) for systemic sclerosis (SSc) at the 8th Systemic Sclerosis World Congress 2024. The data, obtained with the laboratory of Yannick Allanore, MD, Ph.D. from the Hospital Cochin, builds additional evidence for the use of ATO in multiple autoimmune conditions, as observed in various animal models and in recent pilot human clinical trials."

Preclinical • Immunology • Systemic Sclerosis

BioSenic Presents Conclusive Preclinical Data on Its ATO Drug for Key Symptom Control at the 2024 World Congress on Systemic Sclerosis (GlobeNewswire) - "BIOSENIC...presented the latest data on arsenic trioxide (ATO) for the treatment of systemic sclerosis (SSc) at the 8th World Systemic Sclerosis Congress 2024....The scientific communication presented by Anne Cauvet and Professor Allanore demonstrated the effectiveness of ATO in Fra2 transgenic mice, used as a model of symptomatic SSc, a chronic autoimmune disease marked by multi-organ fibrosis. BioSenic has already shown that ATO, a first-in-class specific immunomodulatory drug, has significant therapeutic action in humans, and the company is advancing several formulations for autoimmune diseases in trials. clinics. Researchers also reported that ATO led to significant histological changes in the lungs, a trend toward a decrease in various fibrotic factors, and a strong reduction in vascular remodeling in the SSc mouse model."

Preclinical • Immunology • Systemic Sclerosis

BioSenic patent granted in Canada for broader protection of ATO therapeutic platform (GlobeNewswire) - "The patent, titled 'Use of metal ions to potentiate the therapeutic effects of arsenic,' covers the use of ATO platform in combination with metal ions such as copper. This combination has shown the ability to significantly improve the treatment of autoimmune diseases and could be applied to the treatment of various forms of cancer conditions and infectious pathologies related to cytokine storms...The new patent, granted to BioSenic’s subsidiary company Medsenic, involves two main immediate areas of application. The first one is in immune- and autoimmune-related diseases – specifically, the BioSenic’s lead project in 2024, chronic GvHD and, later on, systemic sclerosis and systemic lupus erythematosus. The second is in oncology, where ATO has already demonstrated exceptional results for patients, including complete remission in acute promyelocytic leukaemia."

Patent • Acute Promyelocytic Leukemia • Chronic Graft versus Host Disease • Systemic Lupus Erythematosus • Systemic Sclerosis

BioSenic on its way to find the necessary funds to perform its key clinical trial on chronic Graft-versus-Host Disease (GlobeNewswire) - "BIOSENIC...today announces that it has signed a term sheet with Singapore based fund TrialCap Pte. Ltd. (the 'Term Sheet') and/or other lenders (the 'Lender') for a proposed debt and equity financing. BioSenic is seeking the funds to continue its clinical development, backed by previous highly promising Phase 2 and pre-clinical results of arsenic trioxide (ATO)....In accordance with the Term Sheet, the Lender will provide two term loan facilities of each up to USD 4,000,000. The facilities will be structured as a loan note facility agreement, with each loan to be advanced in cash directly to the relevant trial service provided or to BioSenic for relevant expenditures under the Phase 3 clinical study with oral arsenic trioxide (OATO) in first-line treatment of chronic Graft-versus-Host Disease (cGvHD)....In addition, under the Term Sheet, the Lender intends to make an equity investment of USD 800,000 in new shares of BioSenic."

Financing • Chronic Graft versus Host Disease

BioSenic performs further analysis of its phase 2 clinical trial data, leading to an optimal administration scheme for its next late-stage trial of arsenic trioxide in cGvHD (GlobeNewswire) - P2 | N=21 | NCT02966301 | Sponsor: Medsenic | "BIOSENIC...today announces the completion of a post-hoc analysis of its phase 2 clinical trial of ATO, finding the best scheme for administration of an efficient treatment of cGvHD. The analysis will be used to decide on the best oral ATO’s posology for BioSenic’s forthcoming phase 3 clinical trial....The primary endpoint of the phase 2 trial was preliminary efficacy based on the overall response rate (ORR; complete response [CR] or partial response [PR]) at 6 months, after 1 or 2 cycles of intravenous (IV) ATO treatment. At 6 months, the ORR was 75.0%, with a CR rate of 35% and PR of 40%....We are now focused on the finalizing preparations for our phase 3 trial of a new oral formulation of ATO targeting chronic graft-versus-host disease..."

New P3 trial • P2 data • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

BioSenic publishes new evidence of beneficial effects of arsenic trioxide treatment supporting clinical trial for systemic sclerosis (GlobeNewswire) - "BIOSENIC...announces the publication of data providing additional key indications of its lead API (Active Pharmaceutical Ingredient) arsenic trioxide (ATO) to treat systemic sclerosis (SSc) in a peer-reviewed international journal....These findings represent a substantial advancement in understanding of the complex interplay between inflammation-driven fibrosis and the pathophysiology of SSc. These results give ground to the proposed clinical relevance of ATO treatment in SSc, and more generally in autoimmune pathologies, where lung is often impacted by fibrosis and vascular remodeling."

Preclinical • Immunology • Systemic Sclerosis

BioSenic presents data on its new copper-arsenic trioxide combination for immunological disorders at the 25th International Conference on Redox Medicine (GlobeNewswire) - "BioSenic...will present the latest data on its arsenic trioxide (ATO) platform at the 25th International Conference on Redox Medicine 2023, held by Redox Medicine Society on June 21-23 in Paris, France...The presentation will focus on recent data for ATO...BioSenic is already evaluating an oral version of ATO (OATO) for systemic autoimmune indications, including an upcoming Phase III study in patients with chronic graft-versus-host disease following allogeneic hematopoietic stem cell transplant."

Clinical data • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • Systemic Lupus Erythematosus • Systemic Sclerosis

Medsenic Partners With Phebra for the Clinical Development of the Oral Form of Arscimed for the Treatment of Autoimmune Diseases (Businesswire) - "Medsenic...announced today that it has entered into an exclusive licensing agreement with Australian company Phebra for the development of their patented OATO formulation (Oral Arsenic Trioxide) in the treatment of autoimmune diseases....Initially the oral formulation of arsenic trioxide (Arscimed) will target the treatment of ambulatory patients with chronic graft-versus-host disease (cGvHD)."

Licensing / partnership • Graft versus Host Disease • Immunology • Systemic Lupus Erythematosus

Medsenic needs 20 million to launch phase III of Arscimed [Google translation] (Les Echos) - "6.5 million euros have been raised to finance the development of Arscimed. Phase III, lasting four years, provides for the recruitment of 160 to 180 patients in various international centers….hopes to be able to conduct several clinical trials in parallel with phase III of chronic GvHD."

Financing • New P3 trial • Graft versus Host Disease • Immunology

Medsenic Announces Positive Results of its Phase II Clinical Study with Arscimed for the Treatment of Chronic Graft Versus Host Disease (cGvHD) (Businesswire) - P2, N=22; NCT02966301; Sponsor: Medsenic; "Medsenic...announced today the positive results of its Phase II clinical study 'GMED-16-001' with its lead product Arscimed®, an intravenous formulation of arsenic trioxide, in patients with Chronic Graft Versus Host Disease (GvHD)....'We look forward to confirming its efficacy in a Phase III study as well as its significant impact on improving the quality of life of GvHD patients'...After the 6-month follow-up, the study's primary endpoint was met in 15 of 21 patients, with a 75% clinical efficacy rate...This very encouraging result was confirmed by a sustained response at 12 months post-treatment in all patients."

P2 data • Graft versus Host Disease