- |||||||||| BMX-010 / BioMimetix
Trial completion date, Trial termination, Trial primary completion date: BMX-DERM-02: A Clinical Trial of BMX-010 in Adult Subjects With Atopic Dermatitis (clinicaltrials.gov) - Apr 18, 2024 P2, N=103, Terminated, Our study is the first to provide evidence for the combined radiotherapy with a novel Mn porphyrin clinical candidate, BMX-001, from the perspective of each cell type within the tumor microenvironment. Trial completion date: Dec 2024 --> Apr 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2024 --> Dec 2023; Funding constraints
- |||||||||| BMX-001 / BioMimetix
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: A Trial for Treatment of Cancer Patients With Multiple Brain Metastases Undergoing Whole-Brain Radiotherapy (clinicaltrials.gov) - Apr 17, 2024 P1/2, N=35, Terminated, Trial completion date: Jul 2024 --> Dec 2024 | Trial primary completion date: Jan 2024 --> Aug 2023 N=69 --> 35 | Trial completion date: Sep 2025 --> Apr 2024 | Recruiting --> Terminated | Trial primary completion date: Aug 2024 --> Dec 2023; Cessation of grant funding
- |||||||||| BMX-001 / BioMimetix
Trial completion date, Trial primary completion date, Metastases: Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With/Without BMX-001 (clinicaltrials.gov) - Feb 15, 2024 P2, N=118, Recruiting, N=69 --> 35 | Trial completion date: Sep 2025 --> Apr 2024 | Recruiting --> Terminated | Trial primary completion date: Aug 2024 --> Dec 2023; Cessation of grant funding Trial completion date: Feb 2028 --> Jun 2029 | Trial primary completion date: Jan 2028 --> May 2027
- |||||||||| BMX-001 / BioMimetix
Trial completion date, Trial primary completion date: Safety Study of BMX-001 (Radio-protector) in Patients With Newly Diagnosed Anal Cancer (clinicaltrials.gov) - Jan 25, 2023 P1/2, N=24, Recruiting, Trial completion date: Jul 2023 --> Jul 2024 | Trial primary completion date: Jan 2023 --> Jan 2024 Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2022 --> Dec 2024
- |||||||||| BMX-010 / BioMimetix
Trial completion date, Trial suspension, Trial primary completion date: Evaluation of Topical Application of BMX-010 in Subjects With Rosacea (clinicaltrials.gov) - Sep 28, 2022 P2, N=60, Suspended, Not yet recruiting --> Recruiting Trial completion date: Nov 2022 --> Mar 2025 | Active, not recruiting --> Suspended | Trial primary completion date: Sep 2022 --> Sep 2024
- |||||||||| BMX-001 / BioMimetix
Preclinical, Journal: Manganese Porphyrin Promotes Post Cardiac Arrest Recovery in Mice and Rats. (Pubmed Central) - Sep 15, 2022 Methods Forty-eight animals were subjected to 8 min of CA and resuscitated subsequently by chest compression and epinephrine infusion...Conclusions We demonstrated the ability of MnBuOE to improve post-CA survival, as well as functional outcomes in both mice and rats, which jointly account for the improvement not only of brain function but also of the overall wellbeing of the animals. While MnBuOE bears therapeutic potential for treating CA patients, the females and the animals with comorbidities must be further evaluated before advancing toward clinical trials.
- |||||||||| BMX-001 / BioMimetix
Trial completion date, Trial primary completion date: BMX-HGG: Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001 (clinicaltrials.gov) - Jul 13, 2022 P2, N=160, Active, not recruiting, Our data demonstrate that the addition of MnP-based redox-active drugs may be used (via increasing excessively the oxidative stress of serous ovarian cancer cells) to improve cancer patients' chemotherapy outcomes, which develop resistance to platinum-based drugs. Trial completion date: Oct 2022 --> Jul 2023 | Trial primary completion date: Apr 2022 --> Dec 2022
- |||||||||| BMX-001 / BioMimetix
Journal: Cardioprotective effects of redox regulator MnTnBuOE-2-PyP in myocardial ischemia/reperfusion injury. (Pubmed Central) - May 14, 2022 These results indicated that a pre-treatment with MnP decreased rotenone-induced 4-HNE aggresomes by enhancing the degradation process. This result provided evidence that MnTnBuOE-2-PyP elicited cytoprotective effects through reduction of mitochondrial oxidative stress and cardiomyocyte apoptosis suggesting prospective therapeutics in myocardial I/R Injury.
- |||||||||| BMX-010 / BioMimetix
Journal: MnTE-2-PyP protects fibroblast mitochondria from hyperglycemia and radiation exposure. (Pubmed Central) - May 12, 2022 MnTE-2-PyP reduced myofibroblast differentiation, improved mitochondrial health by releasing the block on the mitochondrial electron transport chain, enhanced ATP production efficiency, and restored mitochondrial dynamics and metabolism in the irradiated-hyperglycemic prostate fibroblasts. Therefore, we are proposing that one of the mechanisms that MnTE-2-PyP protects prostate fibroblasts from irradiation and hyperglycemia-mediated damage is by protecting the mitochondrial health in diabetic prostate cancer patients.
- |||||||||| BMX-010 / BioMimetix
Journal: MnTE-2-PyPDisrupts Staphylococcus aureus Biofilms in a Novel Fracture Model. (Pubmed Central) - Apr 19, 2022 In vitrocrystal violet assay of biofilm structure and corresponding NBT assay for reactive oxygen species (ROS) demonstrated that MnTE-2-PyP decreased the biofilm structure,and reduced ROS in a correlated and dose-dependent manner. The biofilm structure is redox-sensitive in S. aureus and an ROS scavenger improved the effectof antibiotic therapy in model of biofilm-associated infections.
- |||||||||| BMX-010 / BioMimetix
Journal: Thermal Stability Kinetics and Shelf Life Estimation of the Redox-Active Therapeutic and Mimic of Superoxide Dismutase Enzyme, Mn(III) meso-Tetrakis(N-ethylpyridinium-2-yl)porphyrin Chloride (MnTE-2-PyPCl, BMX-010). (Pubmed Central) - Mar 1, 2022 According to the R1 modelling of the isothermal decomposition data, the estimated shelf life value for 10% decomposition (t ) of MnTE-2-PyPCl at 25°C was approximately 17 years, which is consistent with the high solid-state stability of the compound. These results represent the first study on the solid-state decomposition kinetics of Mn(III) 2-N-alkylpyridylporphyrins, contributing to the development of this class of redox-active therapeutics and SOD mimics and providing supporting data to protocols on purification, handling, storage, formulation, expiration date, and general use of these compounds.
- |||||||||| BMX-001 / BioMimetix
Trial primary completion date: Safety Study of BMX-001 (Radio-protector) in Patients With Newly Diagnosed Anal Cancer (clinicaltrials.gov) - Feb 15, 2022 P1/2, N=24, Recruiting, These results represent the first study on the solid-state decomposition kinetics of Mn(III) 2-N-alkylpyridylporphyrins, contributing to the development of this class of redox-active therapeutics and SOD mimics and providing supporting data to protocols on purification, handling, storage, formulation, expiration date, and general use of these compounds. Trial primary completion date: Dec 2021 --> Dec 2022
- |||||||||| BMX-001 / BioMimetix
Enrollment change, Trial withdrawal, Metastases: Trial of BMX-001 or Placebo in Head and Neck Cancer Patients (clinicaltrials.gov) - Oct 10, 2021 P2, N=0, Withdrawn, Promising rates of severe OM and xerostomia justify further investigation in HNSCC patients receiving CRT. N=162 --> 0 | Not yet recruiting --> Withdrawn
- |||||||||| BMX-010 / BioMimetix
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: Topical Application of BMX-010 in Subjects With Atopic Dermatitis and Plaque Psoriasis (clinicaltrials.gov) - Oct 5, 2021 P2, N=139, Completed, N=162 --> 0 | Not yet recruiting --> Withdrawn Active, not recruiting --> Completed | N=300 --> 139 | Trial completion date: Dec 2022 --> Jul 2021 | Trial primary completion date: Dec 2022 --> Jul 2021
|