Graft-versus-host disease

Orphan designation: anti-CD3 mAb (SPV-T3a)-ricin A chain fusion protein,anti-CD7 mAb (WT1)-ricin A chain fusion protein Treatment of graft-versus-host disease, 26/08/2005 Positive

Retrieved on: 
Thursday, April 18, 2024
Community, Eurostat, Civil service commission, Diagnosis, CD7, Graft-versus-host disease, Cell, Bone marrow, Disease, Patient, Committee, Extrapyramidal system, Tissue, Knowledge, Antibody, Regulation, EMA, IRIS, Protein, CD3, BV, European, Skin, WT1, COMP, Oxygen, Immune system, European Commission, Safety, Hematopoietic stem cell transplantation, Stomach, Liver, Pharmaceutical industry

Orphan designation: anti-CD3 mAb (SPV-T3a)-ricin A chain fusion protein,anti-CD7 mAb (WT1)-ricin A chain fusion protein Treatment of graft-versus-host disease, 26/08/2005 Positive

Key Points: 


Orphan designation: anti-CD3 mAb (SPV-T3a)-ricin A chain fusion protein,anti-CD7 mAb (WT1)-ricin A chain fusion protein Treatment of graft-versus-host disease, 26/08/2005 Positive

EQS-News: ActiTrexx treats first patient with novel regulatory T cell therapy against Graft-versus-Host Disease

Retrieved on: 
Wednesday, April 10, 2024
Cell, Bone marrow, Disease, Transplant, Risk, Clinic, Patient, Gastrointestinal tract, Mortality, Haematopoietic system, Leukemia, Quality of life, Graft-versus-host disease, Clinical trial, Skin, Safety, CSO, Liver, Acute leukemia, Vaccine

GvHD is a severe and potentially life-threatening complication that can arise after an allogeneic haematopoietic stem cell transplantation and affects about 50 % of recipients.

Key Points: 
  • GvHD is a severe and potentially life-threatening complication that can arise after an allogeneic haematopoietic stem cell transplantation and affects about 50 % of recipients.
  • GvHD occurs when the stem cell donor’s T cells attack the patient’s tissues, leading to a range of symptoms that can affect the skin, gastrointestinal tract, and liver.
  • Prof. Dr. Andrea Tüttenberg, CEO of ActiTrexx, said: “GvHD can lead to life-long symptoms for the patient and is a major cause for the high mortality rate of blood stem cell transplantation.
  • Ten patients who have recently received a blood stem cell transplantation as treatment for leukemia will receive a single treatment with Actileucel.

Seres Therapeutics Announces Completion of Patient Enrollment for SER-155 Phase 1B Cohort 2 Clinical Trial in Allogenic HSCT

Retrieved on: 
Tuesday, April 9, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Disease, Allo, Infection, Incidence, Patient, Immune tolerance, Gastrointestinal tract, GI, David Berry (inventor), Mortality, Bacteria, HSCT, Bloodstream infections, Graft-versus-host disease, Therapy, Chronic liver disease, Safety, Immunodeficiency, Data, Pharmaceutical industry

Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, announced today that enrollment is complete in the placebo-controlled Cohort 2 of its Phase 1b trial of SER-155 in patients who received Allogeneic Hematopoietic Stem Cell Transplantation (Allo HSCT).

Key Points: 
  • Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, announced today that enrollment is complete in the placebo-controlled Cohort 2 of its Phase 1b trial of SER-155 in patients who received Allogeneic Hematopoietic Stem Cell Transplantation (Allo HSCT).
  • Infections are a leading cause of mortality and morbidity in this immunocompromised patient population.
  • Our pending clinical results could validate the promise of microbiome therapeutics to prevent poor outcomes associated with pathogens in the GI tract.
  • Study Cohort 2, which includes 45 participants, incorporates a randomized, double-blinded placebo-controlled 1:1 design to further evaluate safety and engraftment, as well as clinical outcomes.

Orphan designation: haematopoietic stem cells and blood progenitors umbilical cord-derived expanded with (1R, 4R)-N1-(2-benzyl-7-(2-methyl-2H-tetrazol-5-yl)-9H-pyrimido[4,5-b]indol-4-yl)cyclohexane-1,4-diamine dihydrobromide dihydrate Treatment in ha[...]

Retrieved on: 
Tuesday, April 9, 2024
Eurostat, Diagnosis, Civil service commission, Graft-versus-host disease, Medicine, Cell, Bone marrow, Risk, Haematopoiesis, Patient, Committee, Knowledge, Regulation, HSCT, EMA, IRIS, European, Leukemia, COMP, Immune system, European Commission, Consultant, Safety, Haematopoietic system, Blood, Marketing, Umbilical cord, CATS, Pharmaceutical industry

Orphan designation: haematopoietic stem cells and blood progenitors umbilical cord-derived expanded with (1R, 4R)-N1-(2-benzyl-7-(2-methyl-2H-tetrazol-5-yl)-9H-pyrimido[4,5-b]indol-4-yl)cyclohexane-1,4-diamine dihydrobromide dihydrate Treatment in haematopoietic stem cell transplantation, 20/04/2020 Positive

Key Points: 


Orphan designation: haematopoietic stem cells and blood progenitors umbilical cord-derived expanded with (1R, 4R)-N1-(2-benzyl-7-(2-methyl-2H-tetrazol-5-yl)-9H-pyrimido[4,5-b]indol-4-yl)cyclohexane-1,4-diamine dihydrobromide dihydrate Treatment in haematopoietic stem cell transplantation, 20/04/2020 Positive

Omeros Corporation Reports Fourth Quarter and Year-End 2023 Financial Results

Retrieved on: 
Monday, April 1, 2024
Mental Health, Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Science, Oncology, PIN, PNH, Patient, Sale, CUD, Graft-versus-host disease, Investment, Clinical trial, Hemolysis, Calcineurin, Emory University, ASH, Risk, L-DOPA, Thumbay Hospital, Behavior informatics, Trial of the century, Myelodysplastic syndrome, Cancer, Safety, Transplant, LID, DRI, BLA, Corporation, Paroxysmal nocturnal hemoglobinuria, Tardive dyskinesia, Parkinson's disease, Publication, DSM-IV codes, Retirement, FDA, PDE7, LDH, Hematology, Mortality, Hematopoietic stem cell transplantation, Bone marrow failure, Abstract, Society, Pharmacology, Pharmaceutical industry

Net loss from continuing operations was $39.3 million for the 2023 fourth quarter compared to $51.7 million for the prior quarter.

Key Points: 
  • Net loss from continuing operations was $39.3 million for the 2023 fourth quarter compared to $51.7 million for the prior quarter.
  • Total operating expenses for the fourth quarter of 2023 were $39.8 million compared to $48.2 million for the third quarter of 2023.
  • Interest expense during the fourth quarter of 2023 was $7.1 million compared to $7.9 million during the prior quarter.
  • During the fourth quarter of 2023, we earned $3.4 million in interest and other income compared to $4.4 million in the third quarter.

Atara Biotherapeutics Announces Fourth Quarter and Full Year 2023 Financial Results and Operational Progress

Retrieved on: 
Thursday, March 28, 2024
Oncology, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, The Lancet, Research, Graft-versus-host disease, LD, ASH, International Society, Partnership, Central nervous system, ATRA, Epstein–Barr virus, Patient, Follicular lymphoma, CNS, Biomarker, PTLD, Cancer, Lymphoproliferative disorders, SLE, EBV, NHL, Lymphoma, Mantle cell lymphoma, Investment, ATM, Safety, Pharmacokinetics, Depreciation, File, Workforce, Cell, FDA, BLA, Lupus nephritis, CD19, Food, Autoimmune disease, Pharmaceutical industry

“We are expanding Atara’s proven EBV T-cell platform into allogeneic CAR T therapy for both oncology and autoimmune disease,” said Pascal Touchon, President and Chief Executive Officer of Atara.

Key Points: 
  • “We are expanding Atara’s proven EBV T-cell platform into allogeneic CAR T therapy for both oncology and autoimmune disease,” said Pascal Touchon, President and Chief Executive Officer of Atara.
  • “This includes strong momentum for our lead CAR T program, ATA3219, which is positioned to deliver near-term clinical data for both non-Hodgkin’s lymphoma and lupus nephritis.
  • Subjects will receive lymphodepletion (LD) treatment followed by ATA3219 at a dose of 40, 80, or 160 x 106 CAR+ T cells.
  • Subjects will receive LD treatment followed by ATA3219 at a dose of 40, 80, 240, or 480 x 106 CAR+ T cells.

Withdrawn application: Orencia, 19/02/2024

Retrieved on: 
Wednesday, April 3, 2024
CD86, Graft-versus-host disease, Gene, Methotrexate, Psoriasis, Letter, Cell, Bone marrow, Risk, Inflammation, Patient, Ageing, Psoriatic arthritis, HSCT, Allele, Joint, Protein, HLA, European Medicines Agency, Arthritis, Syringe, Rheumatism, Agency, Clinical trial, Skin, CD80, Cancer, Immune system, Blood, Calcineurin, Medicine, Vaccine

Withdrawn application: Orencia, 19/02/2024

Key Points: 


Withdrawn application: Orencia, 19/02/2024

PRISM MarketView Spotlights Lipella Pharmaceuticals as it Seizes Opportunities in Rare Disease

Retrieved on: 
Thursday, March 7, 2024
Therapy, FDA, Risk, Graft-versus-host disease, Safety, Drug development, CMC, Patient, Interview, Orphan, Cancer, PRISM, Pharmaceutical industry

NEW YORK, March 07, 2024 (GLOBE NEWSWIRE) -- PRISM MarketView announces the release of an insightful interview with Lipella Pharmaceuticals’ CEO, Dr. Jonathan Kaufman, discussing the company's recent regulatory accomplishments and how investors stand to benefit.

Key Points: 
  • NEW YORK, March 07, 2024 (GLOBE NEWSWIRE) -- PRISM MarketView announces the release of an insightful interview with Lipella Pharmaceuticals’ CEO, Dr. Jonathan Kaufman, discussing the company's recent regulatory accomplishments and how investors stand to benefit.
  • Lipella Pharmaceuticals was recently granted Orphan Drug Designation by the FDA for LP-410, its drug candidate for oral Graft-versus-Host Disease (GvHD) and previously received Orphan Drug Designation for LP-10 in 2023.
  • Dr. Kaufman remarked, “Orphan drug development can often be more profitable, entail lower risk and result in faster time to approval than non-orphan therapeutics.
  • Our goal is to deliver safe and effective treatments as quickly as possible to the patients who need them most,” said Dr. Kaufman.

NMDP Awards 25th Annual ‘Amy Scholars’ Grant, Furthering Post-Transplant Research

Retrieved on: 
Wednesday, March 6, 2024
Bone marrow, Senior, Doctor of Philosophy, HCT, Research, Hematology, Graft-versus-host disease, Physician, Partnership, Data, University, Risk assessment, NMDP, Nursing, Patient, Disease, McGinn, DRS, Health equity, Laboratory, Buchbinder, Wilfrid Sellars, Pharmaceutical industry

Cieri and Sacirbegovic in their research efforts to improve the lives of those battling blood cancers and blood disorders.

Key Points: 
  • Cieri and Sacirbegovic in their research efforts to improve the lives of those battling blood cancers and blood disorders.
  • We are especially grateful to the Moore family, who generously funded the Amy Scholars Research Program in 2024,” said Joy King, Chief Advancement Officer, NMDP, and Executive Director, NMDP.
  • Since 1998, NMDP has invested more than $12 million, funding 51 early-career investigators and helping them develop research portfolios and establish their laboratories.
  • “For years, we have supported groundbreaking research by collaborating with an extensive network of physicians and scientists in impacting outcomes.

Lipella Pharmaceuticals Announces FDA Clearance of IND for LP-410 for Oral Graft-Versus-Host Disease, Advancing Clinical Pipeline

Retrieved on: 
Tuesday, March 5, 2024
Investigational New Drug, Toxicity, FDA, Food, Tacrolimus, GVHD, Patient, Graft-versus-host disease, Efficacy, Trial of the century, Pharmaceutical industry

Lipella’s clinical study, titled, A Multicenter, Dose-Ranging Trial Evaluating the Safety, Tolerability, and Efficacy of LP-410 in Subjects with Symptomatic Oral GVHD, is expected to commence in the second half of 2024.

Key Points: 
  • Lipella’s clinical study, titled, A Multicenter, Dose-Ranging Trial Evaluating the Safety, Tolerability, and Efficacy of LP-410 in Subjects with Symptomatic Oral GVHD, is expected to commence in the second half of 2024.
  • Dr. Jonathan Kaufman, CEO of Lipella, said, “We are extremely pleased to announce the approval of our IND application, and we look forward to initiating clinical testing in patients in 2024.
  • We believe that Lipella’s proprietary oral rinse formulation of liposomal tacrolimus has the potential to effectively treat oral GVHD, while minimizing systemic toxicity.
  • Lipella received FDA Orphan Drug Designation on tacrolimus for treatment of GVHD on November 8, 2023.