disufenton sodium (OKN-007)
/ HLB Bio Group
- LARVOL DELTA
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August 13, 2025
Open-label Study Investigating of OKN-007 Combined With Temozolomide in Patients With Recurrent Glioblastoma
(clinicaltrials.gov)
- P2 | N=57 | Completed | Sponsor: Oblato, Inc. | Active, not recruiting ➔ Completed
Trial completion • Brain Cancer • Glioblastoma • Glioma • High Grade Glioma • Oncology • Solid Tumor • MGMT
March 27, 2025
Sulfatase 2 inhibition sensitizes triple-negative breast cancer cells to paclitaxel through augmentation of extracellular ATP.
(PubMed, Cancer Biol Ther)
- "The highest incidence and cancer-related mortality rate among women worldwide is due to breast cancer. The co-treatment of chemotherapy and OKN-007 also attenuated cancer-initiating cells. This data implies that the combination of SULF2 inhibitors with chemotherapy augments eATP and decreases cell viability of TNBC greater than chemotherapy alone."
Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • SULF1 • SULF2
February 02, 2025
Oklahoma nitrone-007 is an effective anticancer therapeutic agent targeting inflammatory and immune metabolism pathways in endometrial cancer.
(PubMed, J Pharmacol Exp Ther)
- "Our goal was to evaluate the preclinical efficacy and mechanism of action of the anticancer drug Oklahoma Nitrone-007 (OKN-007) alone and in combination with carboplatin and paclitaxel in endometrial cancer. SIGNIFICANCE STATEMENT: Women with advanced and recurrent endometrial cancer have limited therapeutic options. Oklahoma Nitrone-007 (OKN-007), which has minimal toxicity and is currently being evaluated in early-phase clinical trials for the treatment of cancer, is a potential new strategy for the treatment of endometrial cancer."
IO biomarker • Journal • Endometrial Cancer • Oncology • Solid Tumor • IDO1 • IFNG • mTOR • SULF2 • TGFB1
December 05, 2024
The nitrone compound OKN-007 delays motor neuron loss and disease progression in the G93A mouse model of amyotrophic lateral sclerosis.
(PubMed, Front Neurosci)
- "Further, we found no improvement in muscle atrophy or weakness phenotypes in OKN-007 treated G93A mice, and no effect on mitochondrial function or lifespan. Overall, our findings suggest that OKN-007 holds potential as a disease-modifying treatment for ALS, although further research is needed to optimize dosing regimens and understand its long-term effects."
Journal • Preclinical • Amyotrophic Lateral Sclerosis • CNS Disorders • Inflammation • IL1B • IL1R1
November 29, 2024
Study of Safety and Pharmacokinetic Properties of Oral OKN-007 in Patients with Recurrent High-Grade Glioma
(clinicaltrials.gov)
- P1 | N=16 | Active, not recruiting | Sponsor: Oblato, Inc. | Trial primary completion date: Dec 2024 ➔ May 2025
Trial primary completion date • Anaplastic Oligoastrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Malignant Glioma • Oligodendroglioma • Oncology • Solid Tumor
November 08, 2024
Open-label Study Investigating of OKN-007 Combined With Temozolomide in Patients With Recurrent Glioblastoma
(clinicaltrials.gov)
- P2 | N=57 | Active, not recruiting | Sponsor: Oblato, Inc. | Trial completion date: Jan 2025 ➔ May 2025
Trial completion date • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Malignant Glioma • Oncology • Solid Tumor • MGMT
October 15, 2024
Study of Safety and Pharmacokinetic Properties of Oral OKN-007 in Patients with Recurrent High-Grade Glioma
(clinicaltrials.gov)
- P1 | N=16 | Active, not recruiting | Sponsor: Oblato, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2024 ➔ Jun 2025 | Trial primary completion date: May 2024 ➔ Dec 2024
Enrollment closed • Trial completion date • Trial primary completion date • Anaplastic Oligoastrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oligodendroglioma • Oncology • Solid Tumor
July 20, 2024
OKN-007 is an Effective Anticancer Therapeutic Agent Targeting Inflammatory and Immune Metabolism Pathways in Endometrial Cancer.
(PubMed, J Pharmacol Exp Ther)
- "Our goal was to evaluate the pre-clinical efficacy and mechanism of action of Oklahoma Nitrone 007 (OKN-007) alone and in combination with carboplatin and paclitaxel in endometrial cancer. Significance Statement Women with advanced and recurrent endometrial cancer have limited therapeutic options. OKN-007, which has minimal toxicity and is currently being evaluated in early-phase clinical trials for the treatment of cancer, is a potential new strategy for the treatment of endometrial cancer."
IO biomarker • Journal • Endometrial Cancer • Oncology • Solid Tumor • IDO1 • SULF2 • TGFB1
May 08, 2024
OU-SCC-Oblato-001: OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma
(clinicaltrials.gov)
- P1 | N=27 | Active, not recruiting | Sponsor: University of Oklahoma | Trial completion date: Nov 2025 ➔ Nov 2026 | Trial primary completion date: Apr 2024 ➔ Apr 2025
Combination therapy • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor
March 06, 2024
Phase 2 clinical trial of OKN-007 in recurrent malignant glioma
(AACR 2024)
- P2 | "OKN-007 plus Temozolomide (TMZ) increased survival in glioma-bearing mice compared to TMZ alone...Any second-line therapy was acceptable, excluding bevacizumab... Our data indicate that the combination therapy of OKN-007 and TMZ appears safe and, compared to standard lomustine therapy, may prolong OS in rGBM."
Clinical • P2 data • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor
April 05, 2024
Open-label Study Investigating of OKN-007 Combined With Temozolomide in Patients With Recurrent Glioblastoma
(clinicaltrials.gov)
- P2 | N=57 | Active, not recruiting | Sponsor: Oblato, Inc. | Trial completion date: Mar 2024 ➔ Jan 2025 | Trial primary completion date: Jul 2023 ➔ Jun 2024
Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor • MGMT
March 21, 2024
Neuroprotective treatment with the nitrone compound OKN-007 mitigates age-related muscle weakness in aging mice.
(PubMed, Geroscience)
- "Mitochondrial function was improved by OKN-007 treatment, consistent with its potential antioxidative properties. Together, these exciting findings are the first to demonstrate that interventions through neuroprotection can be an effective therapy to counter aging-related muscle dysfunction."
Journal • Preclinical • Metabolic Disorders • Sarcopenia
February 16, 2024
Study of Safety and Pharmacokinetic Properties of Oral OKN-007 in Patients With Recurrent High-Grade Glioma
(clinicaltrials.gov)
- P1 | N=16 | Recruiting | Sponsor: Oblato, Inc. | Phase classification: P1b ➔ P1
Phase classification • Anaplastic Oligoastrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oligodendroglioma • Oncology • Solid Tumor
November 02, 2023
OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma
(clinicaltrials.gov)
- P1 | N=27 | Active, not recruiting | Sponsor: University of Oklahoma | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2025 ➔ Nov 2025 | Trial primary completion date: Dec 2023 ➔ Apr 2024
Combination therapy • Enrollment closed • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor
August 09, 2023
OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma
(clinicaltrials.gov)
- P1 | N=6 | Recruiting | Sponsor: University of Oklahoma | Trial primary completion date: Jun 2023 ➔ Dec 2023
Combination therapy • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor
July 20, 2023
Study of Safety and Pharmacokinetic Properties of Oral OKN-007 in Patients With Recurrent High-Grade Glioma
(clinicaltrials.gov)
- P1b | N=16 | Recruiting | Sponsor: Oblato, Inc. | Initiation date: Dec 2022 ➔ Apr 2023
Trial initiation date • Anaplastic Oligoastrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oligodendroglioma • Oncology • Solid Tumor
March 14, 2023
The inhibition of sulfation of heparan sulfate augments the chemotherapeutic response in triple-negative breast cancer
(AACR 2023)
- "TNBC cell lines MDA-MB 231, Hs 578t, and MDA-MB 468 and non-tumorigenic immortal mammary epithelial MCF-10A cells were treated with increasing concentrations of the chemotherapeutic agent paclitaxel in the presence of heparan sulfate and/or OKN-007, and eATP content and cell viability were evaluated. Our results showed that inhibiting the 6-O desulfation of heparan sulfate increases eATP accumulation, thereby, enhancing TNBC cell lines’ response to chemotherapy. These findings may lead to therapies for TNBC based on sulfatase 2 inhibition that results in more effective responses with fewer side effects."
Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • SULF2
April 21, 2023
Oblato Announces the First Enrollment in a Phase 1 Clinical Trial for an Oral Formulation of OKN-007 in Recurrent High-Grade Glioma Patients in the USA
(PRNewswire)
- "Oblato...has announced today the first enrollment for recurrent high-grade glioma patients in a Phase 1 clinical trial in the USA with an oral formulation of its proprietary compound OKN-007....Along with the ongoing clinical development of an injectable formulation, this Phase 1 trial is expected to broaden the possibility of a new drug approval for the treatment of glioblastoma, a rare and deadly disease."
Enrollment status • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor
March 29, 2023
Clinical Trial of IV OKN-007 in a Pilot Cohort of Human Recurrent Malignant Glioma Patients
(clinicaltrials.gov)
- P1b | N=31 | Active, not recruiting | Sponsor: Oblato, Inc. | Trial completion date: Oct 2022 ➔ Oct 2023 | Trial primary completion date: Jun 2022 ➔ Jan 2023
Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor
February 10, 2023
Study of Safety and Pharmacokinetic Properties of Oral OKN-007 in Patients With Recurrent High-Grade Glioma
(clinicaltrials.gov)
- P1b | N=16 | Recruiting | Sponsor: Oblato, Inc. | Not yet recruiting ➔ Recruiting
Enrollment open • Anaplastic Oligoastrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oligodendroglioma • Oncology • Solid Tumor
October 24, 2020
[VIRTUAL] Phase 1b Clinical Trial of OKN-007 in Recurrent Malignant Glioma
(SNO 2020)
- P1b | "OKN-007 appears safe and, compared to standard therapy, may prolong OS in recurrent glioma."
Clinical • P1 data • Fatigue • Glioblastoma • Glioma • Infectious Disease • Nephrology • Oncology • Pain • Solid Tumor
October 24, 2020
[VIRTUAL] Feasibility pilot study of OKN-007 in combination with adjuvant Temozolomide chemoradiotherapy in patients with newly diagnosed glioblastoma
(SNO 2020)
- P1 | "The treatment plan in Cohort 1 appears safe and well-tolerated. Recruitment for Cohort 2 is ongoing and will be expanded to further evaluate safety. Once the outcome of Cohort 2 is known, the regimen for the expansion cohort will be determined."
Clinical • Combination therapy • Glioblastoma • Neutropenia • Oncology • Solid Tumor
October 26, 2022
Open-label Study Investigating of OKN-007 Combined With Temozolomide in Patients With Recurrent Glioblastoma
(clinicaltrials.gov)
- P2 | N=57 | Active, not recruiting | Sponsor: Oblato, Inc. | Recruiting ➔ Active, not recruiting
Enrollment closed • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor • MGMT
October 25, 2022
Oblato announces that it has completed enrollment of patients for the Phase 2 recurrent glioblastoma multiforme clinical trial in the US
(PRNewswire)
- "Oblato, Inc....announced today that the enrollment of recurrent glioblastoma multiforme (GBM) patients for a Phase 2 clinical trial with its proprietary compound OKN-007 in the US has been completed. Thirteen institutions are participating in this clinical trial, and patients are being administered a combination of OKN-007 and temozolomide, an approved drug for GBM....The Company expects that the study results will be available in 2023....Two other trials for GBM are in progress. One is an investigator-initiated clinical trial using OKN-007 on naïve GBM patients at Stephenson Cancer Center, University of Oklahoma Health Sciences Center and 21 patients have been enrolled so far. Furthermore, Oblato has just started another Phase 1 clinical study for recurrent GBM patients with the dosage form of OKN-007 changed from the existing injectable to an oral formulation to improve both the administration to the patients and the efficacy of OKN-007."
P2 data • Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Oncology
October 07, 2022
Investigation of Oral OKN-007 in Recurrent High-grade Glioma Participants
(clinicaltrials.gov)
- P1/2 | N=0 | Withdrawn | Sponsor: Oblato, Inc. | N=30 ➔ 0 | Not yet recruiting ➔ Withdrawn
Enrollment change • Trial withdrawal • Anaplastic Oligoastrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oligodendroglioma • Oncology • Solid Tumor
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