Glioma

Viseon, Inc. Announces First Cranial Tumor Resection Procedure Enabled by MaxView® 4K Advanced Digital Visualization™

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Tuesday, November 14, 2023

Viseon Inc. announces the company’s first use of the MaxView® 4K Advanced Digital Visualization (4K-ADV™) system during a neurosurgical tumor resection procedure.

Key Points: 
  • Viseon Inc. announces the company’s first use of the MaxView® 4K Advanced Digital Visualization (4K-ADV™) system during a neurosurgical tumor resection procedure.
  • Admittedly, I chose a high hurdle for this first 4K-ADV case in a Vestibular Schwannoma tumor resection.
  • His feedback from the first case was very helpful as we plan to expand our sales emphasis in 2024.
  • The MaxView 4K-ADV System continues to expand the innovative enabling nature of the Viseon digital technology, disrupting legacy standards of large, expensive capital equipment.

Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Status: Authorised

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Monday, December 18, 2023

Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Status: Authorised

NeuExcell's AAV Gene Therapy for Malignant Glioma Granted Orphan Drug Designation by FDA

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Monday, December 18, 2023

PHILADELPHIA, Dec. 18, 2023 /PRNewswire/ -- On December 7, 2023, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation ("ODD") to NXL-004, an investigational AAV gene therapy product being developed by NeuExcell Therapeutics Inc. ("NeuExcell"), for the treatment of malignant glioma.

Key Points: 
  • PHILADELPHIA, Dec. 18, 2023 /PRNewswire/ -- On December 7, 2023, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation ("ODD") to NXL-004, an investigational AAV gene therapy product being developed by NeuExcell Therapeutics Inc. ("NeuExcell"), for the treatment of malignant glioma.
  • This is the world's first AAV gene therapy product for malignant glioma to receive FDA ODD designation.
  • Malignant gliomas are the most common primary malignant brain tumors in adults, about 60% of which are glioblastoma (GBM).
  • Recurrence is virtually inevitable for malignant glioma and there is no clear standard salvage therapy.

The Inner Circle Acknowledges, Joshua T. Billingsley, MD, MS, FAANS, as a Pinnacle Life Member for his contributions to the field of Neurological Surgery

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Wednesday, November 29, 2023

GLENVIEW, Ill., Nov. 29, 2023 /PRNewswire/ -- Prominently featured in The Inner Circle, Joshua T. Billingsley, MD, MS, FAANS, is acknowledged as a Pinnacle Life Member for his contributions to the field of Neurological Surgery.

Key Points: 
  • GLENVIEW, Ill., Nov. 29, 2023 /PRNewswire/ -- Prominently featured in The Inner Circle, Joshua T. Billingsley, MD, MS, FAANS, is acknowledged as a Pinnacle Life Member for his contributions to the field of Neurological Surgery.
  • Neurosurgeons are doctors who diagnose and treat problems with the nervous system, often by performing surgery on the brain or spine.
  • They treat strokes, tumors, cervical and lumbar disc disease, infections, and head or spinal cord injuries.
  • Aside from his professional pursuits, the doctor enjoys cycling; woodworking; and ocean fishing.

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

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Monday, November 27, 2023

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.

New Analyses from Pivotal Phase 3 INDIGO Study Reinforce Vorasidenib's Potential to Change the Treatment Paradigm for IDH-Mutant Diffuse Glioma

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Saturday, November 18, 2023

BOSTON, Nov. 18, 2023 /PRNewswire/ -- New data from Servier's clinical development program for vorasidenib in IDH-mutant diffuse glioma, presented at the 28th Annual Meeting of the Society for Neuro-Oncology (SNO) in Vancouver, Canada, showed that vorasidenib reduced tumor growth as measured by a blinded independent radiology committee. Additional data from the INDIGO study being presented at SNO include health-related quality of life data, indicating patients receiving vorasidenib experience preservation of quality of life, stable neurocognitive function, and seizure control, as well as translational data demonstrating vorasidenib's efficacy across IDH-mutant diffuse gliomas with various additional mutations.

Key Points: 
  • We are honored and excited at the prospect of ushering in a new era of targeted treatment options for patients living with this devastating disease."
  • The safety lead-in was conducted to determine the recommended combination dose for the recently initiated perioperative phase of the study.
  • In this phase, approximately 60 patients will be randomized to the combination treatment, vorasidenib 40 mg once-daily alone, or no treatment prior to surgery.
  • KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

GT Medical Technologies, Inc. Presents Use of GammaTile Therapy is Increasing in Time Across Several Brain Tumor Types at the 28th Annual Scientific Meeting and Education Day at the Society of Neuro-Oncology (SNO)

Retrieved on: 
Friday, November 17, 2023

TEMPE, Ariz., Nov. 17, 2023 /PRNewswire/ -- GT Medical Technologies, Inc., a medical device company dedicated to improving the lives of patients with brain tumors, today announced an increase of clinical cases in the United States using its GammaTile® Therapy in patients diagnosed with several brain tumor types. The data was presented at the Society for Neuro-Oncology (SNO) 28th Annual Meeting and Education Day taking place from November 15-19, 2023, at the Vancouver Convention Center in Vancouver, Canada.

Key Points: 
  • The data was presented at the Society for Neuro-Oncology (SNO) 28th Annual Meeting and Education Day taking place from November 15-19, 2023, at the Vancouver Convention Center in Vancouver, Canada.
  • GammaTile has been used in over 1,000 patients with both newly diagnosed malignant brain tumors and recurrent brain tumors since 2019 and has been used in different tumor types, including glioblastoma, brain metastasis and meningioma.
  • Currently, GammaTile is sponsoring 4 clinical trials including a multi-institute registry trial (NCT0442738) that includes quality of life as a study metric.
  • GammaTile Therapy is a Surgically Targeted Radiation Therapy (STaRT) that delivers immediate radiation and eradicates brain tumor cells before they can replicate post-surgery while helping to protect healthy brain tissue.

ChromaCode Announces Publication Highlighting Advancements in HDPCR NSCLC Assay Performance, Demonstrating Advantages Over Next Generation Sequencing in Enabling Timely Results, and as a Vital 'Rescue' Solution when NGS is not Viable

Retrieved on: 
Tuesday, November 14, 2023

"We are very pleased with the results of this scientific study which demonstrates the utility of the NSCLC assay as an efficient and cost-effective frontline tool to benefit lung cancer patients.

Key Points: 
  • "We are very pleased with the results of this scientific study which demonstrates the utility of the NSCLC assay as an efficient and cost-effective frontline tool to benefit lung cancer patients.
  • In this newly published research, the NSCLC assay demonstrated remarkable sensitivity, even with minimal input material obtained from formalin-fixed paraffin-embedded (FFPE) tissue samples.
  • This technology addresses key challenges in NSCLC diagnosis and treatment by offering rapid biomarker testing with minimal input, making it an ideal choice for laboratories worldwide.
  • 78% of discordant results were resolved in favor of the HDPCR assay.

Scopus BioPharma’s Subsidiary — Duet BioTherapeutics — Presents Compelling New Data for a Novel Treatment for Malignant Glioma at 38th Annual Meeting of the Society for Immunotherapy of Cancer

Retrieved on: 
Tuesday, November 7, 2023

NEW YORK, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Scopus BioPharma Inc. (OTCQB: “SCPS”) and its majority-owned subsidiary, Duet BioTherapeutics Inc., presented compelling new data that DUET-102 in combination with PD-1 blockade demonstrates significant anti-tumor activity in models of malignant glioma.

Key Points: 
  • DUET-102 is a double-stranded antisense oligonucleotide (“ASO”) STAT3 inhibitor linked to a TLR9 immune activator being developed for the treatment of glioma.
  • Glioma is a common type of tumor originating in the glial cells of the brain.
  • DUET-102, as a monotherapy, inhibited tumor growth and extended survival of mice in U251, GL261, and QPP8 models of glioma.
  • There is an acute need for new treatment options for glioma, which have seen no significant advances in the past decade.