Arsenol (arsenic trioxide oral) / SDK Therapeutics - LARVOL DELTA

An arsenolipid accumulates in mouse brain following oral exposure. (PubMed, J Hazard Mater) - "Approximately 0.6% of the administered dose was retained in tissues, with the highest concentrations occurring in the brain, where arsenic was present as both the parent arsenohydrocarbon and its thio metabolite. These findings demonstrate that dietary arsenohydrocarbons can reach and persist in brain tissue, highlighting the need for comprehensive hazard assessment and human health risk evaluation of arsenolipids in seafood."

Journal • Preclinical

Tissue-specific trace element accumulation, mercury and arsenic speciation in Atlantic walrus (Odobenus rosmarus rosmarus). (PubMed, Ecotoxicol Environ Saf) - "Hg:Selenium molar ratios were approximately 21-fold higher in liver than in blubber and were higher in the Hudson Bay-Davis Strait stock. Elevated concentrations of cadmium and methylmercury in liver relative to other tissues highlight tissue-specific accumulation patterns and warrant further investigation of their ecological and physiological implications."

Journal

Simultaneous Determination of Water- and Fat-Soluble Arsenic Species by HPLC-ICP-MS in Food Samples: A Pilot Study. (PubMed, Foods) - "As there are no commercially available arsenolipid standards, the syntheses of AsHC 360 and AsFA 362 were also a part of the study. Additionally, the synthesized arsenolipids were analyzed by LC-MS."

Journal

Targeted and Nontargeted Detection and Quantitation of Arsenolipids in a Tuna Fish Reference Material (BCR-627) Using Reversed-Phase HPLC with High-Resolution Electrospray Mass Spectrometry and Inductively Coupled Plasma Mass Spectrometry. (PubMed, Anal Chem) - "By delivering both an analytically validated targeted and nontargeted workflow for AsLp analysis, and an expanded AsLp species dataset, this study provides essential groundwork for more routine, higher-coverage AsLp speciation in marine organisms, with possibilities for interlaboratory comparisons through the use of the BCR-627 tuna reference material. Thus, introducing a new era in AsLp speciation analysis expected to further promote the development of a field that may be referred to as arsenolipidomics."

Journal

A Trial to Investigate Whether Oral Arsenic Trioxide Is Similar to Intravenous Arsenic Trioxide in Pharmacokinetics, Safety, and Efficacy (LATITUDE/SDKARS-301) (clinicaltrials.gov) - P3 | N=120 | Not yet recruiting | Sponsor: SDK Therapeutics, Inc.

New P3 trial • Acute Promyelocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Pharmacokinetics and cardiac impact of arsenic trioxide (ATO) oral solution (SDK001) under fasting, fed, and calcium carbonate co-administration conditions compared with intravenous ATO in patients with acute promyelocytic leukemia (ASH 2025) - "No drug-drug interaction was observed with calcium carbonate. The risk of QTcF prolongation was attenuatedwith SDK001 compared with that of IV-ATO, which was further reduced with food."

Clinical • PK/PD data • Acute Promyelocytic Leukemia • CNS Disorders • Congestive Heart Failure • Heart Failure • Hematological Malignancies • Leukemia

Discovering the dual degradation pathway of emerald green in oil paints: The effects of light and humidity. (PubMed, Sci Adv) - "By combining results from a historical oil painting by James Ensor (1860 to 1949) and artificially aged paint mock-ups, we identified ultraviolet A-visible light and humidity (relative humidity ≥ 95%) as key driving factors, inducing a dual degradation pathway: Light promotes surface-stratified arsenic oxidation (As3+ → As5+) resulting in amorphous As5+-rich compounds, whereas a dark, high moisture environment favors arsenolite (As2O3) crystallization. In addition, a noninvasive analytical strategy is proposed for monitoring the conservation state of emerald green paints in historical artworks."

Journal

Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution Under Fasting and Fed Conditions, to Compare Intravenous Arsenic Trioxide, in Acute Promyelocytic Leukemia (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: SDK Therapeutics, Inc. | Phase classification: P1/2 ➔ P1

Phase classification • Acute Promyelocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Biotransformation of seafood arsenic by intestinal microbiota: A critical review on ecotoxicological and health risk implications. (PubMed, Ecotoxicol Environ Saf) - "The key functional bacterial genera implicated in these processes are also identified. We conclude that a thorough understanding of these intricate microbe-arsenic interactions is essential for improving ecotoxicological models, accurately assessing health risks associated with seafood consumption, and establishing robust, evidence-based public health guidelines."

Journal • Review

An Entirely Oral Regimen of Oral-Arsenic Trioxide/All-Trans Retinoic Acid/Ascorbic Acid in Newly-Diagnosed Acute Promyelocytic Leukaemia (APL): Updated Results of an Ongoing Multicentre Trial (ASH 2023) - "High-risk patients < 65 years old received in addition daunorubicin (50 mg/m2/day i.v. for 3 days)...APL-DS occurred in 67 patients (58.7%) after initiation of AAA, all responding fully to intravenous dexamethasone... The use of an entirely oral AAA-based induction in a risk-adapted strategy that minimized chemotherapy was highly effective and safe in newly-diagnosed APL of all risk categories and age groups. Early deaths remained an obstacle to realizing a cure-for-all in APL."

Clinical • Acute Promyelocytic Leukemia • Cardiovascular • Cerebral Hemorrhage • Congestive Heart Failure • Gastroenterology • Heart Failure • Hematological Malignancies • Oncology • Pediatrics

Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution Under Fasting and Fed Conditions, to Compare Intravenous Arsenic Trioxide, in Acute Promyelocytic Leukemia (clinicaltrials.gov) - P1/2 | N=12 | Completed | Sponsor: SDK Therapeutics, Inc. | Recruiting ➔ Completed

Trial completion • Acute Promyelocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

A RANDOMIZED, OPEN LABEL, SINGLE-DOSE, 4-PERIOD, 4-TREATMENT CROSS-OVER STUDY TO EVALUATE THE PHARMACOKINETICS OF ORAL ARSENIC TRIOXIDE SOLUTION (SDK001) AND TO COMPARE TO INTRAVENOUS ARSENIC TRIOXIDE (EHA 2025) - "Approximately 12 patients will be enrolled in this study and randomized in a 1:1:1:1 ratio to one of the four treatment sequences with a 7-day washout between periods (Table 1). The primary end-points include: AUCinf of AsIII for the comparison of SDK001 versus i.v.-ATO under fasted condition; Cmax and AUCinf of AsIII, for the comparison of SDK001 under fasted condition versus fed condition; Cmax and AUCinf of AsIII, for the comparison of SDK001 with or without calcium product under fasted state.Table 1 Sequence 1 2 3 4 N 3 3 3 3 Period 1 A B C D Period 2 B D A C Period 3 C A D B Period 4 D C B A A: 0.15 mg/kg i.v.-ATO, fasted; B: 0.15 mg/kg SDK001 fasted; C: 0.15 mg/kg SDK001 fed; D: 0.15 mg/kg SDK001 with 1 g calcium carbonate tablet, fasted."

Clinical • PK/PD data • Acute Myelogenous Leukemia • Acute Promyelocytic Leukemia • Cardiovascular • CNS Disorders • Congestive Heart Failure • Heart Failure • Hematological Malignancies • Leukemia • Oncology • PML

Microstructure and Thermophysical Characterization of Tetra-Arsenic Biselenide As4Se2 Alloy Nanostructured by Mechanical Milling. (PubMed, Materials (Basel)) - "The nanomilled alloys become notably stressed owing to the destruction of molecular thioarsenide and incorporation of their remnants into the newly polymerized arsenoselenide network. This effect is more pronounced in As4Se2 alloy subjected to dry nanomilling, while it is partly counterbalanced when this alloy is additionally subjected to wet milling in a PVP water solution, accompanied by the stabilization of the As4Se2/PVP nanocomposite."

Journal

Oral-ATO for TP53-mutated Myeloid Malignancies (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: The University of Hong Kong | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Biodegradation of Arsenosugars from Red Alga Pyropia haitanensis. (PubMed, Environ Sci Technol) - "C71 efficiently transformed phosphate arsenosugar to glycerol arsenosugar extracellularly and intracellularly. This study offers new insights into the interaction between bacteria and organoarsenical degradation, contributing to our understanding of arsenic biogeochemical cycles in marine systems."

Journal

How does the coupled action of freeze-thaw and acidification affect the release of toxic elements from indigenous Zn smelting slags? (PubMed, J Environ Sci (China)) - "More importantly, the geochemical modeling results suggested that the precipitation of hematite and magnetite, as well as the dissolution of arsenolite, might have little impacts on PTEs release under FTs and FTs with acidification. This work would provide a deeper understanding of PTEs release from smelting waste slags under complex physicochemical interactions."

Journal

Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution Under Fasting and Fed Conditions, to Compare Intravenous Arsenic Trioxide, in Acute Promyelocytic Leukemia (clinicaltrials.gov) - P1/2 | N=12 | Recruiting | Sponsor: SDK Therapeutics, Inc.

New P1/2 trial • Acute Promyelocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Arsenolipid-Induced Reproductive Toxicity in Caenorhabditis elegans: Elucidating the Mechanism through the HUS-1-CEP-1-EGL-1-CED-9-CED-4-CED-3 Signaling Pathway. (PubMed, Food Chem Toxicol) - "In addition, the mechanism of arsenolipid-induced nematode reproductive toxicity was further elucidated through the HUS-1-CEP-1-EGL-1-CED-9-CED-4-CED-3 signaling pathway. Therefore, our results suggest that AsHC 332 is more exposed to reproductive toxicity than AsHC 346 and AsHC 360, which is related to changes in physicochemical properties and DNA damage-induced germ cell apoptosis."

Journal • APAF1 • GAS1 • SOD3

Orphan Designation: treatment of acute promyelocytic leukemia (FDA) - Date Designated: 11/19/2024

Orphan drug • Acute Promyelocytic Leukemia