- |||||||||| acetylcysteine solution / Generic mfg.
Trial initiation date, Combination therapy: Repeated Neural Stem Cell Based Virotherapy for Newly Diagnosed High Grade Glioma (clinicaltrials.gov) - Apr 4, 2024
P1, N=20, Not yet recruiting,
Multi-center sites for enrolling patients to the expansion cohort include City of Hope, Stanford University, Wake Forest University, and Northwestern University. Initiation date: Jan 2024 --> Jun 2024
- |||||||||| Triapine (3-AP) / Vion, Northwestern University
Trial completion date, Combination therapy, Metastases: NRG-GY006: Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers (clinicaltrials.gov) - Sep 26, 2023
P3, N=437, Active, not recruiting,
Trial completion date: Nov 2023 --> Nov 2024 | Trial primary completion date: Nov 2023 --> Nov 2024 Trial completion date: Jun 2024 --> Sep 2024
- |||||||||| Triapine (3-AP) / Vion, Northwestern University
Trial completion date, Trial primary completion date, Combination therapy, Metastases: NRG-GY006: Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers (clinicaltrials.gov) - Jun 26, 2023
P3, N=437, Active, not recruiting,
Trial completion date: Jun 2024 --> Sep 2024 Trial completion date: Jul 2023 --> Jun 2024 | Trial primary completion date: Jul 2023 --> Jan 2023
- |||||||||| claramine / Northwestern University
Preclinical, Journal: PTP1B Inhibitor Claramine Rescues Diabetes-Induced Spatial Learning and Memory Impairment in Mice. (Pubmed Central) - Nov 3, 2022
Furthermore, CA treatment not only significantly down-regulated the expressions of PTP1B and NLRP3 inflammatory related proteins (NLRP3, ASC, Caspase-1, COX-2, IL-1β, and TNF-α), but also significantly up-regulated the expressions of insulin signaling pathway-related proteins (p-IRS1, p-PI3K, p-AKT, and p-GSK-3β) in diabetic mice. Taken together, these results suggested that PTP1B might be a targeted strategy to rescue learning and memory deficits in DM, possibly through inhibition of NLRP3 inflammasome and regulation of insulin signaling pathway.
- |||||||||| Triapine (3-AP) / Vion, Northwestern University
Enrollment closed, Combination therapy, Metastases: NRG-GY006: Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers (clinicaltrials.gov) - Sep 26, 2022
P3, N=450, Active, not recruiting,
Taken together, these results suggested that PTP1B might be a targeted strategy to rescue learning and memory deficits in DM, possibly through inhibition of NLRP3 inflammasome and regulation of insulin signaling pathway. Recruiting --> Active, not recruiting
- |||||||||| claramine / Northwestern University
Journal: A Brain-Permeable Aminosterol Regulates Cell Membranes to Mitigate the Toxicity of Diverse Pore-Forming Agents. (Pubmed Central) - Apr 22, 2022
In this study, we investigate the ability of claramine, a blood-brain barrier permeable small molecule in the aminosterol class, to neutralize the toxicity of acute biological threat agents, including melittin from honeybee venom and α-hemolysin from Staphylococcus aureus...We thus demonstrate that the exogenous administration of an aminosterol can tune the properties of lipid membranes and protect cells from diverse biotoxins, including not just misfolded protein oligomers as previously shown but also biological protein-based toxins. Our results indicate that the investigation of regulators of the physicochemical properties of cell membranes offers novel opportunities to develop countermeasures against an extensive set of cytotoxic effects associated with cell membrane disruption.
- |||||||||| claramine / Northwestern University
Preclinical, Journal: CD36 gene deletion reduces muscle insulin sensitivity in mice by up-regulating PTP1B expression (Pubmed Central) - Apr 19, 2022
Our results indicate that the investigation of regulators of the physicochemical properties of cell membranes offers novel opportunities to develop countermeasures against an extensive set of cytotoxic effects associated with cell membrane disruption. CD36 is essential for maintaining muscle insulin sensitivity under physiological conditions, and CD36 gene deletion in mice causes impaired insulin sensitivity by up-regulating muscle PTP1B expression, which results in detyrosine phosphorylation of IR and IRS1.
- |||||||||| trodulamine (MSI-1436) / Novo Biosci
Review, Journal: From Marine Metabolites to the Drugs of the Future: Squalamine, Trodusquemine, Their Steroid and Triterpene Analogues. (Pubmed Central) - Mar 8, 2022
The discovery of squalamine as the first representative of a previously unknown class of natural antibiotics of animal origin stimulated extensive research of terpenoids (especially triterpenoids) comprising polyamine fragments. During the last decade, this new class of biologically active semisynthetic natural product derivatives demonstrated the possibility to form supramolecular networks, which opens up many possibilities for the use of such structures for drug delivery systems in serum or other body fluids.
- |||||||||| CLD-101 / Calidi Biotherap
Trial completion date, Trial initiation date, Trial primary completion date, Oncolytic virus: Multiple Doses of Neural Stem Cell Virotherapy (NSC-CRAd-S-pk7) for the Treatment of Recurrent High-Grade Gliomas (clinicaltrials.gov) - Feb 17, 2022
P1, N=30, Not yet recruiting,
During the last decade, this new class of biologically active semisynthetic natural product derivatives demonstrated the possibility to form supramolecular networks, which opens up many possibilities for the use of such structures for drug delivery systems in serum or other body fluids. Trial completion date: Jun 2023 --> Dec 2023 | Initiation date: Dec 2021 --> Apr 2022 | Trial primary completion date: Jun 2023 --> Dec 2023
- |||||||||| CLD-101 / Calidi Biotherap
Trial completion, Trial completion date, Oncolytic virus: Neural Stem Cell Based Virotherapy of Newly Diagnosed Malignant Glioma (clinicaltrials.gov) - Jan 11, 2022
P1, N=13, Completed,
Trial completion date: Jun 2023 --> Dec 2023 | Initiation date: Dec 2021 --> Apr 2022 | Trial primary completion date: Jun 2023 --> Dec 2023 Trial completion date: Dec 2021 --> Jul 2021 | Active, not recruiting --> Completed
- |||||||||| NeuroNova-1 / Calidi Biotherap, Northwestern University
Journal, Oncolytic virus: Multiple Treatment Cycles of Neural Stem Cell Delivered Oncolytic Adenovirus for the Treatment of Glioblastoma. (Pubmed Central) - Dec 27, 2021
We recently completed a first-in-human trial assessing the safety of a single intracerebral dose of NSC-delivered CRAd-Survivin-pk7 (NSC.CRAd-S-pk7) combined with radiation and chemotherapy in newly diagnosed high-grade glioma patients...Here, we report IND-enabling studies in which an improvement in treatment efficacy is achieved in immunocompetent mice by administering multiple treatment cycles intracerebrally. The results imply that pre-existing immunity does not preclude therapeutic benefits attainable by administering multiple rounds of an oncolytic adenovirus directly into the brain.
- |||||||||| autologous hematopoietic stem cell therapy / Northwestern University
Clinical, Journal: Long term outcomes of the French ASTIS systemic sclerosis cohort using the global rank composite score. (Pubmed Central) - Oct 15, 2021
Two randomised trials (ASTIS, SCOT) of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) versus monthly Cyclophosphamide for severe Systemic Sclerosis (SSc) patients used similar inclusion criteria, but different primary endpoints: event-free-survival (EFS) at 24 months in ASTIS versus the global rank composite score (GRCS) at 54 months in SCOT...In intention-to-treat analysis, the GRCS demonstrated superiority for AHSCT (median: 9 versus -19, p = 0.018), mRSS (Δ mRSS: -16 versus -9, p = 0.02), and HAQ-DI (ΔHAQ-DI: -0.89 versus -0.2, p = 0.05) with no significant difference in OS, EFS, lung, heart and kidney function between the groups. In conclusion, this study demonstrates long term benefits of non-myeloablative AHSCT when assessed by the five longitudinal measures within GRCS affording direct primary endpoint comparison between ASTIS and SCOT.
- |||||||||| claramine / Northwestern University, Germanin (suramin) / Optimum Therap
Preclinical, Journal: Indole- and Pyrazole-Glycyrrhetinic Acid Derivatives as PTP1B Inhibitors: Synthesis, In Vitro and In Silico Studies. (Pubmed Central) - Sep 17, 2021
The trifluoromethyl derivative of indole-GA (4f) exhibited non-competitive inhibition of PTP1B as well as higher potency (IC = 2.5 µM) than that of positive controls ursolic acid (IC = 5.6 µM), claramine (IC = 13.7 µM) and suramin (IC = 4.1 µM). Finally, docking and molecular dynamics simulations provided the theoretical basis for the favorable activity of the designed compounds.
- |||||||||| Triapine (3-AP) / Vion, Northwestern University
Enrollment open, Combination therapy, Metastases: NRG-GY006: Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers (clinicaltrials.gov) - Sep 5, 2021
P3, N=450, Recruiting,
Finally, docking and molecular dynamics simulations provided the theoretical basis for the favorable activity of the designed compounds. Suspended --> Recruiting
- |||||||||| claramine / Northwestern University
Journal: The aminosterol Claramine inhibits β-secretase 1-mediated insulin receptor cleavage. (Pubmed Central) - Aug 26, 2021
Both of these effects likely contribute to the reduced amount of the proform of BACE1 in the early secretory pathway, thereby reducing insulin receptor cleavage. These newly described properties of Claramine are consistent with its insulin sensitizing effect.
- |||||||||| autologous hematopoietic stem cell therapy / Northwestern University
Review, Journal: New autoimmune diseases after autologous hematopoietic stem cell transplantation for multiple sclerosis. (Pubmed Central) - Jul 28, 2021
Alemtuzumab in the conditioning regimen has been identified as a risk for development of 2ndADs after either allogeneic or autologous HSCT and is consistent with the high rates of 2ndADs when using alemtuzumab as monotherapy. Due to the significant consequences but variable incidence, depending on conditioning regimen, of 2ndADs and similarity in known immune reconstitution kinetics after autologous HSCT for autoimmune diseases and after alemtuzumab monotherapy, we propose that an imbalance between B and T lineage regeneration early after HSCT may underlie the pathogenesis of 2ndADs.
- |||||||||| Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, Lemtrada (alemtuzumab) / Sanofi, autologous hematopoietic stem cell therapy / Northwestern University
[VIRTUAL] OUTCOME OF NON-MYELOABLATIVE AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR MULTIPLE SCLEROSIS: A SINGLE CENTER SUMMARY OF 511 PATIENTS (On-Demand Library) - Feb 4, 2021 - Abstract #EBMT2021EBMT_2152;
The low incidence of bacteremia may be related to the use of non-myeloablative regimens that do not cause mucositis, i.e. gut endothelium bacterial barrier remains closed, placement and removal of the large bore apheresis catheter on the same day and subsequent insertion of a PICC line in the upper inner arm on day of admission resulting in less risk of cutaneous barrier breaches, a HEPA-filtered floor, and to the use of pre-emptive antibiotics when neutropenic. On the other hand, one patient developed legionella pneumonia that was subsequently cultured from the showerhead.
- |||||||||| Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, Lemtrada (alemtuzumab) / Sanofi, autologous hematopoietic stem cell therapy / Northwestern University
[VIRTUAL] OUTCOME OF NON-MYELOABLATIVE AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR MULTIPLE SCLEROSIS: A SINGLE CENTER SUMMARY OF 511 PATIENTS (On-Demand Library) - Feb 4, 2021 - Abstract #EBMT2021EBMT_2151;
The low incidence of bacteremia may be related to the use of non-myeloablative regimens that do not cause mucositis, i.e. gut endothelium bacterial barrier remains closed, placement and removal of the large bore apheresis catheter on the same day and subsequent insertion of a PICC line in the upper inner arm on day of admission resulting in less risk of cutaneous barrier breaches, a HEPA-filtered floor, and to the use of pre-emptive antibiotics when neutropenic. On the other hand, one patient developed legionella pneumonia that was subsequently cultured from the showerhead.
- |||||||||| Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, Lemtrada (alemtuzumab) / Sanofi, autologous hematopoietic stem cell therapy / Northwestern University
[VIRTUAL] OUTCOME OF NON-MYELOABLATIVE AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR MULTIPLE SCLEROSIS: A SINGLE CENTER SUMMARY OF 511 PATIENTS (On-Demand Library) - Feb 4, 2021 - Abstract #EBMT2021EBMT_2150;
The low incidence of bacteremia may be related to the use of non-myeloablative regimens that do not cause mucositis, i.e. gut endothelium bacterial barrier remains closed, placement and removal of the large bore apheresis catheter on the same day and subsequent insertion of a PICC line in the upper inner arm on day of admission resulting in less risk of cutaneous barrier breaches, a HEPA-filtered floor, and to the use of pre-emptive antibiotics when neutropenic. On the other hand, one patient developed legionella pneumonia that was subsequently cultured from the showerhead.
- |||||||||| Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, Lemtrada (alemtuzumab) / Sanofi, autologous hematopoietic stem cell therapy / Northwestern University
[VIRTUAL] OUTCOME OF NON-MYELOABLATIVE AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR MULTIPLE SCLEROSIS: A SINGLE CENTER SUMMARY OF 511 PATIENTS (On-Demand Library) - Feb 4, 2021 - Abstract #EBMT2021EBMT_2149;
The low incidence of bacteremia may be related to the use of non-myeloablative regimens that do not cause mucositis, i.e. gut endothelium bacterial barrier remains closed, placement and removal of the large bore apheresis catheter on the same day and subsequent insertion of a PICC line in the upper inner arm on day of admission resulting in less risk of cutaneous barrier breaches, a HEPA-filtered floor, and to the use of pre-emptive antibiotics when neutropenic. On the other hand, one patient developed legionella pneumonia that was subsequently cultured from the showerhead.
- |||||||||| Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
Trial termination: Stem Cell Transplantation for Stiff Person Syndrome (SPS) (clinicaltrials.gov) - Jan 6, 2021
P1/2, N=23, Terminated,
Long-term follow-up will be essential for assessing the quality of life after this regimen. Active, not recruiting --> Terminated; Could not predict who would respond, relapse or go into remission
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