Neurotoxicity

Innovative Cellular Therapeutics (ICT) Presented Data at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting

Retrieved on: 
Wednesday, May 24, 2023
Gene, Diarrhea, CRS, RECIST, Clinical trial, Neurotoxicity, CAR, ICT, Hospital, Cytokine release syndrome, Patient, Cell, American Society of Gene and Cell Therapy, Society, ORR, Safety, Pharmaceutical industry

ROCKVILLE, Md., May 24, 2023 (GLOBE NEWSWIRE) -- Innovative Cellular Therapeutics, Inc. (ICT), a clinical-stage biotechnology company developing a comprehensive portfolio of chimeric antigen receptor (CAR) T cell therapies for solid tumors, today announced the Company presented at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual meeting in Los Angeles, California.

Key Points: 
  • ROCKVILLE, Md., May 24, 2023 (GLOBE NEWSWIRE) -- Innovative Cellular Therapeutics, Inc. (ICT), a clinical-stage biotechnology company developing a comprehensive portfolio of chimeric antigen receptor (CAR) T cell therapies for solid tumors, today announced the Company presented at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual meeting in Los Angeles, California.
  • ICT presented GCC19CART, its lead product candidate from the Company’s CoupledCAR® technology, being developed to treat patients with relapsed/refractory metastatic colorectal cancer (R/R mCRC) in an oral presentation.
  • Thirteen patients were enrolled in dose level 1 (1x106 cells/kg) and 8 patients were enrolled in dose level 2 (2x106 cells/kg).
  • GCC19CART is now in clinical development in the U.S. and is on track to complete Phase 1 dose escalation clinical trial this year.

Artiva Biotherapeutics Presents Initial Data from First-in-Human Phase 1/2 Clinical Trial of AB-101 at the 2023 ASCO Annual Meeting

Retrieved on: 
Thursday, May 25, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Complete Response Letter, Rituximab, Graft-versus-host disease, Northwest Biotherapeutics, Febrile neutropenia, CRS, Umbilical cord, Cyclophosphamide, NK, Toxicity, Șaeș, ASCO, Combination therapy, Bone marrow suppression, American Society of Clinical Oncology, Patient, Standard of care, Cytopenia, Annual general meeting, Steroid, Symantec Endpoint Protection, Partial-response maximum-likelihood, Society, Neurotoxicity, ORR, Safety, Vaccine, Pharmaceutical industry, Fever

Artiva Biotherapeutics, Inc. , a clinical stage company whose mission is to deliver highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies, announced today the presentation of initial data from the dose-escalation stage of its ongoing Phase 1/2 clinical trial of AB-101.

Key Points: 
  • Artiva Biotherapeutics, Inc. , a clinical stage company whose mission is to deliver highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies, announced today the presentation of initial data from the dose-escalation stage of its ongoing Phase 1/2 clinical trial of AB-101.
  • The presentation will take place on Monday, June 5, during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
  • Myelosuppression, consistent with standard lymphodepletion regimens, was the most common Grade ≥ 3 toxicity, but was manageable with standard of care.
  • In the combination cohort, only one unrelated Grade 3 SAE of pyrexia was noted.​ There were no treatment-related AEs leading to discontinuation of AB-101.​

Marketing Authorisation Application for lecanemab submitted in Great Britain: BioArctic

Retrieved on: 
Monday, May 22, 2023
CET, Health care, Lecanemab, Brain, Clarity, Eisai, Co-promotion, Marketing Authorisation Application, MAA, Innovation, AD, Neurotoxicity, MHRA, Disease, Pharmaceutical industry, Biogen

Lecanemab has been designated by the MHRA for the Innovative Licensing and Access Pathway (ILAP).

Key Points: 
  • Lecanemab has been designated by the MHRA for the Innovative Licensing and Access Pathway (ILAP).
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.
  • BioArctic has the right to commercialize lecanemab in the Nordic region and currently Eisai and BioArctic are preparing for a joint commercialization in the region.

Marketing Authorisation Application for lecanemab submitted in Great Britain: BioArctic

Retrieved on: 
Monday, May 22, 2023
CET, Health care, Lecanemab, Brain, Clarity, Eisai, Co-promotion, Marketing Authorisation Application, MAA, Innovation, AD, Neurotoxicity, MHRA, Disease, Pharmaceutical industry, Biogen

Lecanemab has been designated by the MHRA for the Innovative Licensing and Access Pathway (ILAP).

Key Points: 
  • Lecanemab has been designated by the MHRA for the Innovative Licensing and Access Pathway (ILAP).
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.
  • BioArctic has the right to commercialize lecanemab in the Nordic region and currently Eisai and BioArctic are preparing for a joint commercialization in the region.

Health Canada Accepts New Drug Submission for Lecanemab as Treatment for Early Alzheimer's Disease

Retrieved on: 
Tuesday, May 16, 2023
Priority review, The New England Journal of Medicine, Plaque, NDS, Alzheimer's disease, MHLW, Marketing, Neurotoxicity, Food, Advisory Committee, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, Lecanemab, Ministry of Health, Labour and Welfare, Brain, Medication, Pharmaceuticals and Medical Devices Agency, Oncology Drug Advisory Committee, EMA, Clarity, Ministry, Eisai, The Different Forms of Flowers on Plants of the Same Species, Prescription Drug User Fee Act, PMDA, National Medical Products Administration, Co-promotion, PDUFA, Ministry of Health (Kuwait), MAA, AD, FDA, Phase, Health Canada, BLA, NMPA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Disease, Medical imaging, Pharmaceutical industry, Biogen, Health

Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.

Key Points: 
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.
  • Lecanemab was approved under the accelerated approval pathway in the U.S. and was launched in the U.S. on January 18, 2023.

Health Canada Accepts New Drug Submission for Lecanemab as Treatment for Early Alzheimer’s Disease

Retrieved on: 
Tuesday, May 16, 2023
Priority review, The New England Journal of Medicine, Plaque, NDS, MHLW, Marketing, Neurotoxicity, Food, Advisory Committee, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, Lecanemab, BIIB, Ministry of Health, Labour and Welfare, Brain, Pharmaceuticals and Medical Devices Agency, Medication, Oncology Drug Advisory Committee, EMA, Clarity, Ministry, The Different Forms of Flowers on Plants of the Same Species, Eisai, Prescription Drug User Fee Act, Headquarters, PMDA, National Medical Products Administration, Corporation, Co-promotion, PDUFA, Ministry of Health (Kuwait), MAA, AD, FDA, Phase, Health Canada, BLA, NMPA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Disease, Pharmaceutical industry, Biogen, Health

Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.

Key Points: 
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.
  • Lecanemab was approved under the accelerated approval pathway in the U.S. and was launched in the U.S. on January 18, 2023.

CDC Data Shows More US Children are Overexposed to Fluoride Than Ever Before

Retrieved on: 
Monday, May 8, 2023
Yang, Tissue, National Health and Nutrition Examination Survey, Ecotoxicology, Water, Prevalence, The United People of Canada, Government, Cochrane (organisation), CDC, Uric acid, National Health, Menstruation, Blood, Kidney, NHANES, Biophysical environment, Infant, Fluorosis, Sleep, Neurotoxicity, Korea Disease Control and Prevention Agency, Dental, Birth control, Dentistry, Phosphorus

NORTH SUTTON, N.H., May 8, 2023 /PRNewswire/ -- Government data shows that tens-of-millions of U.S. residents have visible signs of overexposure to fluoride.

Key Points: 
  • NORTH SUTTON, N.H., May 8, 2023 /PRNewswire/ -- Government data shows that tens-of-millions of U.S. residents have visible signs of overexposure to fluoride.
  • The US Centers For Disease Control's (CDC) National Health and Nutrition Examination Survey (NHANES) has consistently found skyrocketing rates of dental fluorosis, reports the Fluoride Action Network .
  • The CDC reported that 41% of adolescents (12 to 15) had dental fluorosis in 2004.
  • At the time, this was an increase of over 400% from the rates found 60 years prior.

Allogene Therapeutics Reports First Quarter 2023 Financial Results and Business Update

Retrieved on: 
Wednesday, May 3, 2023
Graft-versus-host disease, COVID-19, Respiratory failure, AACR, B-cell lymphoma, Kite Pharma, CD70, CRS, RCC, Neoplasm, Multiple myeloma, DCR, American Society of Clinical Oncology, Cancer, Timothy, Licensure, American Association for Cancer Research, GAAP, FC, Neurotoxicity, PFS, Infection, UNIVERSAL, ASCO, CAR, Partial, PIN, Dor, Patient, Cytokine release syndrome, MM, IVD, Weather, Research, Therapy, Headache, Society, DL2, ORR, News, Cytopenia, BCMA, Safety, Fatigue, Vaccine, Pharmaceutical industry, Medical imaging, Insurance, Investment

“Our first quarter progress continues to establish Allogene as the leader in the development of allogeneic CAR T product candidates,” said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene.

Key Points: 
  • “Our first quarter progress continues to establish Allogene as the leader in the development of allogeneic CAR T product candidates,” said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene.
  • Research and development expenses were $80.2 million for the first quarter of 2023, which includes $9.2 million of non-cash stock-based compensation expense.
  • General and administrative expenses were $18.9 million for the first quarter of 2023, which includes $9.6 million of non-cash stock-based compensation expense.
  • Allogene will host a live conference call and webcast today at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss financial results and provide a business update.

Innovative Cellular Therapeutics (ICT) Presented Updated Data at the American Association for Cancer Research (AACR) Annual Meeting

Retrieved on: 
Tuesday, May 2, 2023
AACR, Diarrhea, CRS, RECIST, Clinical trial, Neurotoxicity, American Association for Cancer Research, CAR, ICT, Hospital, Cytokine release syndrome, Patient, ORR, Safety, Pharmaceutical industry

ICT presented GCC19CART, its lead product candidate from the Company’s CoupledCAR® technology, being developed to treat patients with relapsed/refractory metastatic colorectal cancer (R/R mCRC) in an oral presentation.

Key Points: 
  • ICT presented GCC19CART, its lead product candidate from the Company’s CoupledCAR® technology, being developed to treat patients with relapsed/refractory metastatic colorectal cancer (R/R mCRC) in an oral presentation.
  • Details for the oral presentation are as follows:
    This presentation highlights data from the 21 patients who were enrolled in two dose escalation groups at 5 hospitals in China.
  • Thirteen patients were enrolled in dose level 1 (1x106 cells/kg) and 8 patients were enrolled in dose level 2 (2x106 cells/kg).
  • GCC19CART is now in clinical development in the U.S. and is on track to complete Phase 1 dose escalation clinical trial this year.

Gene Switch Global Market Report 2023: Numerous Positive Breakthroughs Draw the Attention of Key Pharmaceutical Players - ResearchAndMarkets.com

Retrieved on: 
Thursday, April 27, 2023
Biotechnology, Genetics, Health, ACT, Graft-versus-host disease, DNA, Partnership, GVHD, Apostles in the New Testament, CRS, Oxygen, CPC, Overalls, Clinical trial, Enzyme, Cell proliferation, Light, DSM-IV codes, Toxicity, Research, Infection, Attention, Gene expression, RNA, Element, TCR, II, Organization, Sangamo Therapeutics, US, TILS, Protein, Cytokine release syndrome, Investment, Patent, Plasmid, OFF, III, Gene, Neurotoxicity, Oligonucleotide, Safety, Geography, Agriculture, Pharmaceutical industry, Vaccine, Video game, Fine chemical, Retail

The report features an extensive study of the current market landscape and future opportunity for the players involved in the development of gene switch.

Key Points: 
  • The report features an extensive study of the current market landscape and future opportunity for the players involved in the development of gene switch.
  • The global gene switch market is anticipated to grow at an annualized growth rate (CAGR) of 14% during the period 2023-2035.
  • Further, North America is anticipated to capture the major share of the gene switch market in 2035.
    Who are the Key Players in the Gene Switch Market?
  • Answer: The global gene switch market is expected to grow at a CAGR of 14%, during the period 2023-2035.