Tocilizumab

Genentech’s Phase III EMPACTA Study Showed Actemra Reduced the Likelihood of Needing Mechanical Ventilation in Hospitalized Patients With COVID-19 Associated Pneumonia

Retrieved on: 
Friday, September 18, 2020
Health, Infectious diseases, Hospitals, Clinical trials, Pharmaceutical, Biotechnology, Health, Articles, Clinical research, Design of experiments, Pharmaceutical industry, Immunosuppressants, Orphan drugs, Tocilizumab, Clinical trial, Coronavirus disease, Placebo-controlled study, Clazakizumab, the EMPACTA Trial, the REMDACTA Trial, Actemra, Genentech

The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra arm versus 19.3% in the placebo arm.

Key Points: 
  • The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra arm versus 19.3% in the placebo arm.
  • Actemra is currently being investigated as a potential treatment for COVID-19 associated pneumonia, including in combination with an anti-viral in the Phase III REMDACTA clinical trial.
  • Results from the Phase III COVACTA trial in patients with severe COVID-19 associated pneumonia were released in July.
  • EMPACTA (Evaluating Minority Patients with Actemra) is a Phase III, randomized, double-blind, placebo-controlled multicenter study (EMPACTA, NCT04372186) to evaluate the efficacy and safety of Actemra in the treatment of hospitalized COVID-19 associated pneumonia among patients that are often underrepresented in clinical trials.

Ormendes SA - First Published Clinical Trial In COVID-19 Suggests Role of Live Biotherapeutic Candidate in Seriously Ill Patients

Retrieved on: 
Friday, September 11, 2020
Health, Clinical trials, Research, Pharmaceutical, Science, Biotechnology, Medical specialties, RTT, Clinical medicine, Medicine, Chloroarenes, Orphan drugs, Feces, Hydroxychloroquine, Tocilizumab, Diarrhea

Patients were divided into two groups: one of 42 patients and the other one of 28.

Key Points: 
  • Patients were divided into two groups: one of 42 patients and the other one of 28.
  • Both groups received a treatment based on hydroxychloroquine, antibiotics, and/or tocilizumab, whereas only the 28 patients in the second group concomitantly received Sivomixx800.
  • Interestingly, nearly all patients treated with bacteriotherapy showed remission of diarrhea and improvement in fever, physical weakness and myalgia within few days.
  • The data from this independent study are preliminary and will need to be confirmed by a more extensive trial.

Corvus Pharmaceuticals Provides Update on Clinical Trial of CPI-006 for Patients with COVID-19

Retrieved on: 
Thursday, September 10, 2020
Health, Articles, Clinical research, Medicine, Medical statistics, Coronavirus disease, Occupational safety and health, Zoonoses, Clinical endpoint, COVID-19 drug development, Tocilizumab

In addition, all of these patients were discharged from the hospital with clinical improvement and none experienced any drug-related safety issues.

Key Points: 
  • In addition, all of these patients were discharged from the hospital with clinical improvement and none experienced any drug-related safety issues.
  • The open-label, Phase 1 study is expected to enroll up to 30 hospitalized COVID-19 patients with mild to moderate symptoms.
  • Patients will receive medications, therapies, and interventions per standard treatment protocols for COVID-19 for the duration of the study.
  • The study also will examine safety and other clinical endpoints, including time to resolution of symptoms and duration of hospitalization.

Aclaris Therapeutics Supports Investigator-Initiated Clinical Trial of ATI-450 for Cytokine Release Syndrome in Hospitalized Patients with COVID-19

Retrieved on: 
Wednesday, June 17, 2020
Medical specialties, Medicine, Interleukins, Immunosuppressants, Immunology, Genentech, Tocilizumab, Cytokine, Interleukin 6, Interleukin-6 receptor

Aclaris is supporting an investigator-initiated trial of ATI-450 for cytokine release syndrome (CRS) in 36 hospitalized patients with COVID-19, and will provide funding and clinical drug supply to the University of Kansas Medical Center (KUMC), the sponsor of the trial.

Key Points: 
  • Aclaris is supporting an investigator-initiated trial of ATI-450 for cytokine release syndrome (CRS) in 36 hospitalized patients with COVID-19, and will provide funding and clinical drug supply to the University of Kansas Medical Center (KUMC), the sponsor of the trial.
  • Many of the investigational drugs that are being evaluated to treat CRS target a single cytokine, said Dr. David Gordon, Chief Medical Officer of Aclaris.
  • We believe inhibiting multiple cytokines has the potential to achieve clinical benefits in patients with CRS, and this study will explore if ATI-450 is an effective approach in these patients.
  • Cytokine release syndrome in severe COVID-19: interleukin-6 receptor antagonist tocilizumab may be the key to reduce mortality.

Hackensack Meridian Health Observational Study Demonstrates Lack of Efficacy of Hydroxychloroquine Among Hospitalized COVID-19 Patients But Finds First Treatment (tocilizumab) to Improve Survival

Retrieved on: 
Wednesday, May 27, 2020
Drugs, RTT, Chloroarenes, Hydroxychloroquine, Quinolines, Tocilizumab, Hackensack, New Jersey, Medical specialties

EDISON, N.J., May 27, 2020 /PRNewswire/ --Hackensack Meridian Health, New Jersey's largest and most comprehensive health network, has utilized its large observational database of more than 3,000 hospitalized COVID-19 patients to show that the touted malaria treatment, hydroxychloroquine, does not improve survival for hospitalized patients.

Key Points: 
  • EDISON, N.J., May 27, 2020 /PRNewswire/ --Hackensack Meridian Health, New Jersey's largest and most comprehensive health network, has utilized its large observational database of more than 3,000 hospitalized COVID-19 patients to show that the touted malaria treatment, hydroxychloroquine, does not improve survival for hospitalized patients.
  • However, another drug, tocilizumab, appears to improve survival among critically ill intensive care unit (ICU) patients.
  • Results from the study include the following:
    Among 2,512 hospitalized patients with COVID-19, 76 percent received at least one dose of hydroxychloroquine and 59 percent received hydroxychloroquine with azithromycin.
  • Hackensack Meridian Health is a member of AllSpire Health Partners, an interstate consortium of leading health systems, to focus on the sharing of best practices in clinical care and achieving efficiencies.

Positive Results from the Second Phase III SAkuraStar Study for Chugai’s Satralizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD) Published in The Lancet Neurology

Retrieved on: 
Friday, April 24, 2020
Communications, Health, Clinical trials, Publishing, Pharmaceutical, Biotechnology, Monoclonal antibodies, Medical specialties, Immunology, Immunosuppressants, Organ systems, Autoimmune diseases, Satralizumab, Neuromyelitis optica, Anti-IL-6, Inebilizumab, Tocilizumab, neuromyelitis optica spectrum disorder (NMOSD), satralizumab

Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that the results of the SAkuraStar Study (NCT02073279), a global phase III clinical study of satralizumab (development code: SA237) were published on April, 22 (local time) in The Lancet Neurology.

Key Points: 
  • Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that the results of the SAkuraStar Study (NCT02073279), a global phase III clinical study of satralizumab (development code: SA237) were published on April, 22 (local time) in The Lancet Neurology.
  • Satralizumab is an anti-IL6 receptor humanized recycling antibody under development for the treatment of neuromyelitis optica spectrum disorder (NMOSD).
  • The phase III study examined the efficacy and safety of satralizumab as monotherapy for adults with NMOSD.
  • The most common adverse events in the satralizumab group were urinary tract infection and upper respiratory tract infection.

Genentech Announces FDA Approval of Clinical Trial for Actemra to Treat Hospitalized Patients With Severe COVID-19 Pneumonia

Retrieved on: 
Monday, March 23, 2020
FDA, Health, Infectious diseases, Clinical trials, Pharmaceutical, Biotechnology, Health, Genentech, Hoffmann-La Roche, South San Francisco, California, Immunosuppressants, Food and Drug Administration, Pharmaceutical industry, Clinical trial, Tocilizumab, Coronavirus, the Clinical Trial, Actemra, Genentech

We thank the FDA for rapidly expediting the approval of this clinical trial to evaluate Actemra in critically ill patients suffering from pneumonia following coronavirus infection and were moving forward to enroll as quickly as possible, said Alexander Hardy, chief executive officer of Genentech.

Key Points: 
  • We thank the FDA for rapidly expediting the approval of this clinical trial to evaluate Actemra in critically ill patients suffering from pneumonia following coronavirus infection and were moving forward to enroll as quickly as possible, said Alexander Hardy, chief executive officer of Genentech.
  • To date, several independent clinical trials have begun globally to explore the efficacy and safety of Actemra for the treatment of patients with COVID-19 pneumonia.
  • In addition, Actemra is not currently approved for this use by the FDA.
  • The Actemra RA subcutaneous clinical development program included two Phase III clinical studies and enrolled more than 1,800 people with RA in 33 countries.

Can-Fite to Explore the anti-Coronavirus Effects of Piclidenoson in Collaboration with Lewis Katz School of Medicine at Temple University

Retrieved on: 
Friday, March 13, 2020
Biotechnology, Infectious diseases, Health, Pharmaceutical, Clinical trials, Medical specialties, Medicine, Clinical medicine, Rheumatology, RTT, Immunosuppressants, Autoimmune diseases, Arthritis, Tocilizumab, Rheumatoid arthritis

(NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, is entering into a collaborative research agreement with the Lewis Katz School of Medicine at Temple University, Philadelphia, USA.

Key Points: 
  • (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, is entering into a collaborative research agreement with the Lewis Katz School of Medicine at Temple University, Philadelphia, USA.
  • This work aims to provide a more solid foundation for our ongoing efforts to understand the potential of Piclidenoson in these therapeutic areas.
  • In some patients, coronaviruses create uncontrolled immune response and rheumatoid arthritis drugs may be used for treatment.
  • Recently, China has approved the use of Roches Actemra, approved by U.S. FDA to treat rheumatoid arthritis, to treat coronavirus patients with serious lung damage.

Vizient Shares Insights into CAR-T Data for Cytokine Release Syndrome, Large B-cell Cancer and Pediatric Leukemia at 2020 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR

Retrieved on: 
Monday, March 2, 2020
Research, General Health, Pharmaceutical, Oncology, Data management, Technology, Hospitals, Clinical trials, Science, Medical Supplies, Practice Management, Health, Medicine, Clinical medicine, Cancer treatments, Medical specialties, Gene therapy, Immune system, Virotherapy, Immunosuppressants, Tocilizumab, Chimeric antigen receptor T cell, Immunotherapy, Cytokine release syndrome

Vizient, Inc. recently shared insights on chimeric antigen receptor T-cell (CAR-T) data and its implications for patients with cytokine release syndrome, large B-cell cancer, and pediatric and young adult patients with leukemia.

Key Points: 
  • Vizient, Inc. recently shared insights on chimeric antigen receptor T-cell (CAR-T) data and its implications for patients with cytokine release syndrome, large B-cell cancer, and pediatric and young adult patients with leukemia.
  • The meeting included clinicians, administrators, clinical research professionals, laboratory technicians and pharmacists and focused on issues in hematopoietic cell transplantation and cellular therapy.
  • Vizients Alyssa Hartsell Harris, presented three posters at the event:
    Real-World Quality and Cost Burden of Cytokine Release Syndrome (CRS) Requiring Tocilizumab or Steroids during CAR-T Infusion Encounter.
  • Quality and Cost Outcomes in Chimeric Antigen Receptor T-Cell Immunotherapy in Adult Large B-Cell Cancer Patients from the Vizient Clinical Database.

Cumberland Pharmaceuticals Receives FDA Approval for RediTrex™ Product Line

Retrieved on: 
Monday, December 2, 2019
Drugs, Medical specialties, Immunosuppressants, Medicine, RTT, Methotrexate, Psoriasis, Food and Drug Administration, Adalimumab, Tocilizumab

NASHVILLE, Tenn., Dec. 2, 2019 /PRNewswire/ --Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for RediTrex, its new line of methotrexate products.

Key Points: 
  • NASHVILLE, Tenn., Dec. 2, 2019 /PRNewswire/ --Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for RediTrex, its new line of methotrexate products.
  • The approval of the product came after a number of communications with the FDA and several amendments to the New Drug Application we submitted to the FDA in late 2018.
  • "We are delighted by the FDA approval of RediTrex for the United States," said A.J.
  • Cumberland will launch two injectable methotrexate product lines within the U.S., with both product offerings intended for the treatment of active rheumatoid arthritis, juvenile idiopathic arthritis and severe psoriasis.