Isocitrate dehydrogenase

BrainSpec Receives Full FDA Clearance to Begin Using AI-Backed Solution for Non-Invasive Brain Chemistry Measurement

Retrieved on: 
Monday, November 27, 2023
Traumatic brain injury, Glioma, Classification, Television, Brain, Isocitrate dehydrogenase, Hope, Alzheimer's disease, Neurochemistry, Dana–Farber Cancer Institute, Tissue, Hospital, Disease, Database, MRS, Patient, Neuroradiology, FDA, Neoplasm, Neuro-Oncology (journal), IDH, Epilepsy, Multiple sclerosis, Diagnosis, Software, Doctor of Philosophy, MRI, Physician, Health, Cone Health Women's Hospital, Medical imaging, MD, Brigham

BOSTON, Nov. 27, 2023 /PRNewswire/ -- BrainSpec, the comprehensive software platform enabling virtual biopsies of the brain, has been awarded clearance by the FDA to begin using their Magnetic Resonance Spectroscopy (MRS) platform to provide non-invasive measurement of brain chemistry to support the diagnostic process in the most common brain-related illnesses, including Alzheimer's disease, multiple sclerosis, epilepsy, brain tumors, and more. This marks the first-time software using a reference database of brain chemistry has been included in an FDA clearance.

Key Points: 
  • First-ever brain chemistry database will allow clinicians to quickly infer brain biomarker data to support the diagnostic process in conditions such as Alzheimer's Disease and Traumatic Brain Injury.
  • BrainSpec Core™ shows 85% sensitivity and 90% specificity in detecting 2-Hydroxyglutarate, an oncometabolite present in low-grade gliomas.
  • This marks the first-time software using a reference database of brain chemistry has been included in an FDA clearance.
  • By using non-invasive imaging, BrainSpec Core™ measures concentrations of chemicals in the brain in order to create a virtual biopsy using standard MRI scanners.

HUTCHMED Highlights Presentations at American Association for Cancer Research Annual Meeting 2023

Retrieved on: 
Wednesday, April 12, 2023
Glioma, FGFR, Differentiable function, Brownstone, Isocitrate dehydrogenase, Acute myeloid leukemia, AML, Cancer, IDH2, IDH, IDH1, Malignant transformation, Chondrosarcoma, Cholangiocarcinoma, Vaccine

Mutant IDHs (“mIDHs”) cause accumulated 2-hydroxyglutarate, leading to blockage of cell differentiation, thereby inducing malignant transformation.

Key Points: 
  • Mutant IDHs (“mIDHs”) cause accumulated 2-hydroxyglutarate, leading to blockage of cell differentiation, thereby inducing malignant transformation.
  • Thus, simultaneous inhibition on both mIDH1 and mIDH2 may be a promising strategy to overcome resistance and improve clinical efficacy.
  • HMPL-306, a dual inhibitor of mIDH1/mIDH2, developed by HUTCHMED, is being evaluated in clinical trials ( NCT04272957 , NCT04762602 , NCT04764474 ).
  • HMPL-453, a highly selective inhibitor of fibroblast growth factor receptors 1, 2, and 3, displays potent activity in FGFR-altered tumor models

DEBIOPHARM REINFORCES THE BOND BETWEEN SWISS AND JAPANESE CANCER RESEARCH WITH THE 2022 JCA MAUVERNAY AWARD CEREMONY

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Monday, October 3, 2022
Chronic myelomonocytic leukemia, Association, Translational research, CLL, Lymphoma, TET2, RHOA, JCA, Research, Myelodysplastic syndrome, Disease, Lymphatic system, SF, AML, Infection, Chronic lymphocytic leukemia, Japanese Cancer Association, CHF, Acute myeloid leukemia, Medicine, Oncogene, Dasatinib, Safety, RNA, Patient, General Medicine Faculty of RostGMU (Rostov State Medical University), IDH, Isocitrate dehydrogenase, MDS, University, CMML, Pharmaceutical industry, Debiopharm

LAUSANNE, Switzerland , Oct. 3, 2022 /PRNewswire/ -- Debiopharm (www.debiopharm.com), a Swiss-based global biopharmaceutical company, today announced the two winners of JCA Mauvernay Award for breakthrough Japanese oncology research projects in 2 categories: Innovative and/or Disruptive Research – Dr. Akihide Yoshimi and for Translational Research – Prof. Mamiko Sakata-Yanagimoto. The winners were honored with trophies and a monetary prize during the live event of the 81st Annual Meeting of the Japanese Cancer Association (JCA) on Saturday, October 1st in Yokohama, Japan by Prof. Hideyuki Saya President of the JCA and Thierry Mauvernay, President of Debiopharm, and Bertrand Ducrey CEO of Debiopharm. 

Key Points: 
  • "The previous winners of the Mauvernay Award have immediately becomevery well-known scientists in our country, becoming professors and leaders in significant institutes.
  • Therefore, I would say that the Mauvernay Award is definitely a huge step for young cancer research scientists in our country."
  • Dr. Akihide Yoshimi's disruptive research at the National Cancer Center Research Institute, is aimed at understanding and targeting aberrant RNA splicing inhematological malignancies.
  • Since 2005, the Japanese Cancer Association (JCA) and Debiopharm have co-organized the 'JCA-Mauvernay Award'.

Global Isocitrate Dehydrogenase (IDH) inhibitors Pipeline Research Report 2022 Featuring Bayer, Agios Pharma, Daiichi Sankyo, & Ohm Oncology - ResearchAndMarkets.com

Retrieved on: 
Friday, July 29, 2022
Pharmaceutical, Health, Clinical Trials, III, Isocitrate dehydrogenase, INDIGO, Route, Enzyme, TCA, Discovery, IDH, IDH2, News, Clinical trial, Agios Pharmaceuticals, Administration, AML, IDH1, Patient, Acute myeloid leukemia, Therapy, Mutation, Route of administration, II, Pharmaceutical industry, TET

The "Isocitrate Dehydrogenase (IDH) inhibitors- Pipeline Insight, 2022" clinical trials has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Isocitrate Dehydrogenase (IDH) inhibitors- Pipeline Insight, 2022" clinical trials has been added to ResearchAndMarkets.com's offering.
  • This "Isocitrate Dehydrogenase (IDH) inhibitors - Pipeline Insight, 2022" report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in Isocitrate Dehydrogenase (IDH) inhibitors pipeline landscape.
  • This segment of the report provides insights about the different Isocitrate Dehydrogenase (IDH) inhibitors drugs segregated based on following parameters that define the scope of the report.
  • Isocitrate Dehydrogenase (IDH) inhibitors pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

Orbus Therapeutics’ Phase 3 Eflornithine STELLAR Study Reaches Full Patient Enrollment

Retrieved on: 
Wednesday, January 19, 2022
Survival, Anaplastic astrocytoma, Ornithine decarboxylase, Safety, Overalls, EMA, European Medicines Agency, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Population, Lomustine, Achievement, CEO, Efficacy, GLOBE, Committee, Radiation, Isocitrate dehydrogenase, Glioma, Irradiation, IDH, PALO, Committee for Medicinal Products for Human Use, PFS, Therapy, Company, European Directive on Traditional Herbal Medicinal Products, Neuron, Cancer, OS, Food, CHMP, FDA, Brain, Prevalence, Trial of the century, ORR, Pharmaceutical industry, Medical imaging, Eflornithine, Patient

PALO ALTO, Calif., Jan. 19, 2022 (GLOBE NEWSWIRE) -- Orbus Therapeutics Inc., a private, late-stage biopharmaceutical company focused on the development and commercialization of therapies that treat rare diseases, today announced that patient enrollment of its Phase 3 STELLAR clinical study of eflornithine in patients with recurrent anaplastic astrocytoma is complete. The STELLAR study completed full enrollment with a total of 343 patients.

Key Points: 
  • PALO ALTO, Calif., Jan. 19, 2022 (GLOBE NEWSWIRE) -- Orbus Therapeutics Inc., a private, late-stage biopharmaceutical company focused on the development and commercialization of therapies that treat rare diseases, today announced that patient enrollment of its Phase 3 STELLAR clinical study of eflornithine in patients with recurrent anaplastic astrocytoma is complete.
  • The STELLAR study completed full enrollment with a total of 343 patients.
  • We are delighted to announce that we have completed enrollment of patients in the STELLAR study.
  • The STELLAR study is the largest randomized Phase 3 study that has been conducted in this patient population, said Bob Myers, co-founder and CEO.

Precipio Launches New HemeScreen Panel for AML, with an unparalleled 4-hour turnaround-time

Retrieved on: 
Monday, May 10, 2021
Enzymes, IDH1, IDH2, Isocitrate dehydrogenase, Brain tumor, Rare diseases, Oncology

The evaluation of several gene mutations is now becoming standard of care for diagnosis, prognostic stratification, and differentially tailored treatment strategies1.

Key Points: 
  • The evaluation of several gene mutations is now becoming standard of care for diagnosis, prognostic stratification, and differentially tailored treatment strategies1.
  • IDH2 mutations can be associated with IDH1 mutation.5\nKIT: This mutation expression is found in approximately 80% of AML cases.
  • Patients with a KIT mutation have a poor prognosis and clinical outcome, therefore potentially requiring more aggressive treatment.
  • These forward-looking statements are only predictions, subject to risks and uncertainties, and actual results could differ materially from those discussed.

Precipio Launches its Proprietary HemeScreen™ AML (Acute Myeloid Leukemia) Molecular Panel

Retrieved on: 
Tuesday, September 22, 2020
Enzymes, IDH1, CD135, Isocitrate dehydrogenase, IDH2, Calreticulin, RTT

This new panel expands the HemeScreen offering for reference laboratories and physician office laboratories, enabling them to provide improved patient care through faster turnaround time.

Key Points: 
  • This new panel expands the HemeScreen offering for reference laboratories and physician office laboratories, enabling them to provide improved patient care through faster turnaround time.
  • Among the key genes that comprise the molecular testing for AML and are part of Precipios HemeScreen AML Panel are IDH1, IDH2, FLT3 and KIT mutations.
  • However a survey conducted by Precipio found that some of the largest reference laboratories in the US took 7-14 days to deliver results for molecular testing for AML.
  • As part of the HemeScreen product line of assays, HemeScreen AML joins our current HemeScreen MPN panel which includes the important JAK2, MPL and CALR genes.

Chi-Med Initiates a Phase I Trial of IDH1/2 Dual Inhibitor in Patients with Hematological Malignancies in China

Retrieved on: 
Friday, July 24, 2020
Enzymes, IDH1, Isocitrate dehydrogenase, IDH2

This is a multi-center study to evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of HMPL306 in patients of relapsed or refractory hematological malignancies with an IDH1 and/or IDH2 mutation.

Key Points: 
  • This is a multi-center study to evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of HMPL306 in patients of relapsed or refractory hematological malignancies with an IDH1 and/or IDH2 mutation.
  • The second stage of the study is a dose expansion phase where three cohorts of patients will receive HMPL306 to further evaluate the safety, tolerability, and clinical activity at the RP2D.
  • There were an estimated 19,700 new cases of AML in China in 2018 and is estimated to reach 24,200 in China in 2030.5In China no IDH inhibitor has been approved.
  • For further discussion of these and other risks, see Chi-Meds filings with the U.S. Securities and Exchange Commission and on AIM.

FDA Grants Breakthrough Device Designation to Thermo Fisher Scientific's Oncomine Precision Assay to Identify IDH1 and IDH2 Mutations in Low-Grade Glioma Patients

Retrieved on: 
Monday, June 15, 2020
Enzymes, Tyrosine kinase receptors, IDH1, ROS1, IDH2, Glioma, Anaplastic lymphoma kinase, Isocitrate dehydrogenase, Thermo Fisher Scientific, Biomarker, HER2/neu, Thermo

CARLSBAD, Calif., June 15, 2020 /PRNewswire/ --The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Thermo Fisher Scientific's Oncomine Precision Assay to identify low-grade glioma (LGG) patients with isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutations who may be eligible for vorasidenib (AG-881).

Key Points: 
  • CARLSBAD, Calif., June 15, 2020 /PRNewswire/ --The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Thermo Fisher Scientific's Oncomine Precision Assay to identify low-grade glioma (LGG) patients with isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutations who may be eligible for vorasidenib (AG-881).
  • Once cleared under PMA, the Oncomine Precision Assay will maximize detection of guideline-recommended biomarkers, such as EGFR, ALK, KRAS, BRAF, ROS1, NTRK, RET, HER2 and others.
  • When combined with the Genexus System, molecular testing laboratories can generate comprehensive NGS results within the same timeframe as single-gene tests.
  • Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion.

Agios Presents Updated Data from the Phase 1 Dose-escalation Study of Vorasidenib in Patients with IDH-mutant Non-enhancing Glioma

Retrieved on: 
Friday, May 29, 2020
Enzymes, Brain tumor, RTT, Glioma, Glioblastoma, IDH1, Isocitrate dehydrogenase

These promising efficacy and safety data in patients with IDH-mutant non-enhancing glioma provide further support for our registration-enabling Phase 3 INDIGO study, said Chris Bowden, M.D., chief medical officer at Agios.

Key Points: 
  • These promising efficacy and safety data in patients with IDH-mutant non-enhancing glioma provide further support for our registration-enabling Phase 3 INDIGO study, said Chris Bowden, M.D., chief medical officer at Agios.
  • Vorasidenib is being evaluated as a single agent in an ongoing Phase 1 dose-escalation trial in IDH1/2 mutant advanced solid tumors (n=93), including glioma (n=52).
  • Patients received daily doses of vorasidenib ranging from 10 mg to 200 mg.
    Thirty-six percent of patients (n=8) remain on treatment.
  • Glioma presents in varying degrees of tumor aggressiveness, ranging from slower growing (low-grade glioma) to rapidly progressing (high-grade glioma-Glioblastoma Multiforme).