Glioma

Orphan designation: Thiophene methylimidazole pentahydrogen Diagnosis of glioma, 12/01/2024 Positive

Retrieved on: 
Thursday, April 18, 2024
Diagnosis, Patient, Committee, Glioma, EMA, IRIS, COMP, European Commission, Marketing, Medicine, Pharmaceutical industry

Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the diagnosis of glioma on 12 January 2024.
  • Orphan designation does not mean the medicine is available or authorised for use.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

Orphan designation: carboplatin Treatment of glioma, 19/02/2024 Positive

Retrieved on: 
Thursday, April 18, 2024
Patient, Committee, Carboplatin, Glioma, EMA, IRIS, COMP, European Commission, Marketing, Medicine, Pharmaceutical industry

Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the treatment of glioma on 19 February 2024.
  • Orphan designation does not mean the medicine is available or authorised for use.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

Orphan designation: Florilglutamic acid (18F) Diagnosis of glioma, 21/03/2016 Withdrawn

Retrieved on: 
Tuesday, April 9, 2024
Eurostat, Diagnosis, Civil service commission, Radiation, Personality, Brain, Headache, MRI, 18F, Aminolevulinic acid, Cell, Survival, Disease, Seizure, Magnetic resonance imaging, Patient, Committee, Knowledge, Glioma, PET, Tissue, Regulation, Cancer, FDOPA, EMA, IRIS, Nausea, European, Fluorodeoxyglucose (18F), COMP, Somatic symptom disorder, Sponsor, European Commission, Safety, Vomiting, Marketing, Hepatocellular carcinoma, Molecular imaging, Medicine, Pharmaceutical industry

Orphan designation: Florilglutamic acid (18F) Diagnosis of glioma, 21/03/2016 Withdrawn

Key Points: 


Orphan designation: Florilglutamic acid (18F) Diagnosis of glioma, 21/03/2016 Withdrawn

Genprex Collaborators Publish Positive Preclinical Data with NPRL2 Gene Therapy Utilizing Oncoprex® Delivery System

Retrieved on: 
Tuesday, April 2, 2024
TUSC2, Toxicity, LLC2, Gene, Growth, NSCLC, Diabetes, Risk, Patient, Lung, Neoplasm, Glioma, Mouse, Manuscript, Cancer, Pembrolizumab, NPRL2, Lung cancer, Stomach, BioRxiv, Hepatocellular carcinoma, NK, Natural killer T cell

AUSTIN, Texas, April 2, 2024 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that its research collaborators have published positive preclinical data for the NPRL2 tumor suppressor gene, utilizing the Company's non-viral Oncoprex® Delivery System, in KRAS/STK11 mutant anti-PD1 resistant non-small cell lung cancer (NSCLC) in a humanized mouse model.

Key Points: 
  • Genprex's Oncoprex® Delivery System is a novel non-viral approach that utilizes lipid-based nanoparticles in a lipoplex form to deliver tumor suppressor genes deleted during the course of cancer development.
  • Genprex believes this system allows for delivery of a number of cancer-fighting genes, alone or in combination with other cancer therapies, to combat multiple types of cancer.
  • "These positive preclinical data are very encouraging and support NPRL2 gene therapy as a potential treatment for a sub-group of NSCLC in which patients traditionally are resistant to existing therapies," said Rodney Varner, President, Chairman and Chief Executive Officer at Genprex.
  • In conclusion, researchers reported that NPRL2 gene therapy induces anti-tumor activity through dendritic cell-mediated antigen presentation and cytotoxic immune cell activation.

73% CNS ORR! FDA Granted ODD to Utidelone Injectable (UTD1) from Biostar Pharma for the Treatment of Breast Cancer Brain Metastasis

Retrieved on: 
Friday, March 29, 2024
ODD, Lung cancer, HER2, Epothilone, Survival, Prognosis, Brain, BBB, Central nervous system, Synthetic biology, Patient, SAN, CNS, Etoposide, Triple-negative breast cancer, Glioma, Traffic barrier, CBR, Bevacizumab, Breast cancer, PFS, FDA, TNBC

As of now, there is only one drug approved for the treatment of BCBM globally, suggesting huge unmet medical needs [1].

Key Points: 
  • As of now, there is only one drug approved for the treatment of BCBM globally, suggesting huge unmet medical needs [1].
  • Utidelone has the ability to cross BBB due to its unique physicochemical characteristic and insusceptibility to P-glycoprotein-mediated efflux.
  • The FDA granted ODD to utidelone injectable for the treatment of BCBM based on these promising data.
  • Considering utidelone's excellent BBB-crossing capability and its therapeutic potential for brain tumors, Biostar Pharma also plans to advance the clinical studies of utidelone injectable for the treatments of other brain tumors such as lung cancer brain metastasis and glioma this year.

Janux Announces Encouraging Safety and Efficacy Data in Ongoing Dose Escalation Trials for PSMAxCD3-TRACTr JANX007 in mCRPC and EGFRxCD3-TRACTr JANX008 in Solid Tumors

Retrieved on: 
Monday, February 26, 2024
Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Other Science, Science, Oncology, NSCLC, Head, Incidence, Neck, EGFR, Toxicity, TCE, Colorectal cancer, SCCHN, RCC, Prostate, PSMA, Renal cell carcinoma, CRC, Lung, PR, Glioma, Interim, Lung cancer, Safety, Breast, Therapy, Liver disease, Patient, PSA, RECIST, Cytokine release syndrome, CD28, CRS, PD-L1, Cancer

“These clinical data show encouraging safety and efficacy with JANX007 in metastatic castration-resistant prostate cancer and with JANX008 in late-stage solid tumors.

Key Points: 
  • “These clinical data show encouraging safety and efficacy with JANX007 in metastatic castration-resistant prostate cancer and with JANX008 in late-stage solid tumors.
  • JANX007 is in a Phase 1a clinical trial in subjects with advanced or metastatic prostate cancer (mCRPC).
  • As of February 12, 2024, 23 subjects were treated with JANX007 in the dose escalation portion of the Phase 1a clinical trial.
  • Based on this safety profile, we are continuing in the dose escalation and optimization portion of the trial for JANX008.

Janux Therapeutics to Host Virtual Event Discussing Updated Clinical Data for PSMA-TRACTr JANX007 and EGFR-TRACTr JANX008

Retrieved on: 
Tuesday, February 20, 2024
Health, General Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Head, Neck, EGFR, Colorectal cancer, Prostate, PSMA, Renal cell carcinoma, Lung, Glioma, Breast, Lung cancer, Safety, Therapy, Clinical trial, CD28, PD-L1, Vaccine

Specifically, the company will provide clinical efficacy and safety updates to report on progress towards identifying doses for expansion studies with JANX007, and on early dose escalation data for JANX008.

Key Points: 
  • Specifically, the company will provide clinical efficacy and safety updates to report on progress towards identifying doses for expansion studies with JANX007, and on early dose escalation data for JANX008.
  • The company anticipates providing an update on identifying doses to be evaluated in expansion cohorts for JANX007 in 2H 2024.
  • Janux’s first clinical candidate, JANX007, is a TRACTr that targets PSMA and is being investigated in a Phase 1 clinical trial in adult subjects with mCRPC.
  • In addition to named programs, Janux is generating a number of unnamed TRACTr and TRACIr programs for potential future development.

Servier Receives Regulatory Filing Acceptances from FDA and EMA for Vorasidenib in the Treatment of IDH-Mutant Diffuse Glioma

Retrieved on: 
Wednesday, February 21, 2024
Orbis, Classification, PFS, European Commission, EMA, Traffic barrier, Progression-free survival, Confidence interval, Committee, Enzyme, MAA, Research and development, ASCO, Malignancy, Physician, FDA, PDUFA, Society, Glioma, TGR, Microsoft Access, Safety, INDIGO, Prognosis, Civil service commission, HR, CHMP, SNO, IDH, Patient, Medicine, BIRC, Public, Disease, Diagnosis, Mutation, Development, NDA, Priority review, Pharmaceutical industry

BOSTON and SURESNES, France, Feb. 21, 2024 /PRNewswire/ -- Servier, a global leader in oncology focused on delivering meaningful therapeutic progress for the patients it serves, today announced the FDA filing acceptance and priority review for a New Drug Application (NDA) for vorasidenib, as well as the EMA granting accelerated assessment for the vorasidenib Marketing Authorization Application (MAA). This innovative targeted therapy is an oral, selective, highly brain-penetrant dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes for the treatment of IDH-mutant diffuse glioma. If approved, vorasidenib would become a first-in-class targeted therapy for patients with IDH-mutant gliomas and would mark Servier's sixth approval across IDH-mutant cancers. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 20, 2024, while the European Commission approval is anticipated in the second half of 2024.

Key Points: 
  • This innovative targeted therapy is an oral, selective, highly brain-penetrant dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes for the treatment of IDH-mutant diffuse glioma.
  • If approved, vorasidenib would become a first-in-class targeted therapy for patients with IDH-mutant gliomas and would mark Servier's sixth approval across IDH-mutant cancers.
  • "In the realm of glioma treatment, innovation has been stagnant for nearly a quarter-century, posing challenges for patients who, post-surgery, may opt to defer treatment due to concerns around potential toxic side effects.
  • "This promising outcome brings hope to patients grappling with IDH-mutant diffuse gliomas, offering a potential breakthrough for those eagerly awaiting a new therapeutic option."

Astonishing brain tumour research wins the BIAL Award in Biomedicine 2023 worth 300,000 Euro

Retrieved on: 
Wednesday, February 21, 2024
Nobel Prize, Bial, University of Glasgow, Messenger, Synapse, Teaching hospital, Glioblastoma, Neuron, Neoplasm, Thought, University Hospital Heidelberg, University of Bergen, Vaccine, University, Haukeland University Hospital, COVID-19, Memory, Glioma, Jury, Heidelberg University, University Hospital Mannheim, Brain, Epilepsy, Tissue, Research, German Cancer Research Center, Medical imaging

This is possible by formation of synapses between neurons and cancer cells.

Key Points: 
  • This is possible by formation of synapses between neurons and cancer cells.
  • This paper shows that cancer cells cannot merely proliferate - they have to hijack healthy biological processes and integrate themselves into the normal function of tissues.
  • "Nowhere is this more blatant - and surprising - than in the brain tumours studied in this paper", says Ralph Adolphs.
  • The award-winning research also provides a new explanation for why epilepsy and tumour progression are often observed together: epilepsy may be a cause, rather than a consequence of the tumour progression.

Astonishing brain tumour research wins the BIAL Award in Biomedicine 2023 worth 300,000 Euro

Retrieved on: 
Wednesday, February 21, 2024
Nobel Prize, Bial, University of Glasgow, Messenger, Synapse, Teaching hospital, Glioblastoma, Neuron, Neoplasm, Thought, University Hospital Heidelberg, University of Bergen, Vaccine, University, Haukeland University Hospital, COVID-19, Memory, Glioma, Jury, Heidelberg University, University Hospital Mannheim, Brain, Epilepsy, Tissue, Research, German Cancer Research Center, Medical imaging

This is possible by formation of synapses between neurons and cancer cells.

Key Points: 
  • This is possible by formation of synapses between neurons and cancer cells.
  • This paper shows that cancer cells cannot merely proliferate - they have to hijack healthy biological processes and integrate themselves into the normal function of tissues.
  • "Nowhere is this more blatant - and surprising - than in the brain tumours studied in this paper", says Ralph Adolphs.
  • The award-winning research also provides a new explanation for why epilepsy and tumour progression are often observed together: epilepsy may be a cause, rather than a consequence of the tumour progression.