Acute phase proteins

Takeda and Arrowhead Collaborate to Co-Develop and Co-Commercialize ARO-AAT for Alpha-1 Antitrypsin-Associated Liver Disease

Retrieved on: 
Thursday, October 8, 2020
Pharmaceutical, Health, Clinical trials, Other Health, Medical specialties, RTT, Anatomy, Hepatology, Acute phase proteins, Alpha-1 antitrypsin deficiency, Serpinopathies, Organ systems, Alpha-1 antitrypsin, Liver disease, Liver, Arrowhead Pharmaceuticals, Alpha-1 Antitrypsin-Associated Liver Disease, ARO-AAT, Takeda Pharmaceutical Company Limited, Arrowhead Pharmaceuticals

We are excited to collaborate with Arrowhead to bring forward this exciting late-stage liver asset for the Alpha-1 community as part of our growing GI portfolio.

Key Points: 
  • We are excited to collaborate with Arrowhead to bring forward this exciting late-stage liver asset for the Alpha-1 community as part of our growing GI portfolio.
  • Alpha-1 Antitrypsin-Associated Deficiency (AATD) is a rare genetic disorder associated with liver disease in children and adults and pulmonary disease in adults.
  • Individuals with the homozygous PiZZ genotype have severe deficiency of functional AAT leading to pulmonary disease and liver disease.
  • However, augmentation therapy does nothing to treat liver disease, and there is no specific therapy for hepatic manifestations.

National Hemophilia Foundation Revises Treatment Guidelines for Factor 1 Deficiency to Include Octapharma’s fibryga®

Retrieved on: 
Wednesday, October 7, 2020
Biotechnology, General Health, Pharmaceutical, Health, Blood, Anatomy, Body fluids, Coagulation system, Congenital disorders, Blood products, Transfusion medicine, Acute phase proteins, Fibrinogen, Cryoprecipitate, Congenital hypofibrinogenemia, Factor I deficiency

The National Hemophilia Foundation (NHF) has revised its treatment recommendations for congenital fibrinogen (Factor 1) deficiency to include fibryga , Fibrinogen (Human) Lyophilized Powder for Reconstitution, for Intravenous Use.

Key Points: 
  • The National Hemophilia Foundation (NHF) has revised its treatment recommendations for congenital fibrinogen (Factor 1) deficiency to include fibryga , Fibrinogen (Human) Lyophilized Powder for Reconstitution, for Intravenous Use.
  • View the full release here: https://www.businesswire.com/news/home/20201007005220/en/
    The National Hemophilia Foundation (NHF) has revised its treatment recommendations for congenital fibrinogen (Factor 1) deficiency to include fibryga, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for Intravenous Use.
  • We are committed to providing life-saving treatment options to people with rare bleeding disorders, including Factor 1 deficiency.
  • Fibrinogen replacement therapies for Factor 1 deficiency include fibrinogen concentrates or cryoprecipitate.

Published In Vivo Study Concludes Hemovent’s MOBYBOX™ ECLS Device Provides “Excellent (Long-Term) Safety and Physiologic Efficacy”

Retrieved on: 
Friday, June 5, 2020
Medical devices, Health, Surgery, Research, Cardiology, Science, Blood, Branches of biology, Coagulation system, Anatomy, Acute phase proteins, Blood proteins, Intensive care medicine, Medical equipment, Extracorporeal membrane oxygenation, Fibrinogen, Platelet, Coagulation

Hemovent GmbH announced today that a study of its CE-marked MOBYBOX ECMO device has been published in The Annals of Thoracic Surgery (Volume 109, Issue 6, p1684-1691, June 01, 2020).

Key Points: 
  • Hemovent GmbH announced today that a study of its CE-marked MOBYBOX ECMO device has been published in The Annals of Thoracic Surgery (Volume 109, Issue 6, p1684-1691, June 01, 2020).
  • The study concluded that Hemovents MOBYBOX ECLS device provides excellent safety and physiologic efficacy in a 7-day (long-term) sheep experiment without visible clotting, hemolysis, or sustained reductions in fibrinogen or platelets.
  • Safety and Efficacy of a novel pneumatic-driven ECMO device.
  • The company has been granted CE mark for the MOBYBOX System and is currently preparing a post-market clinical follow-up (PMCF) study.

Remestemcel-L Improves Respiratory and Functional Outcomes in Patients With Inflammatory Lung Disease

Retrieved on: 
Monday, June 1, 2020
Medical specialties, Medicine, Clinical medicine, Intensive care medicine, Acute phase proteins, Blood tests, Immunologic tests, Biomarkers, C-reactive protein, Mesoblast, Respiratory disease, Chronic obstructive pulmonary disease

The post-hoc analysisfrom arandomized, placebo-controlled 60-patient Phase 2 trial in patients with COPD showed that remestemcel-L, given in four monthly intravenous doses of 100 million cells, significantly improved respiratory and functional clinical outcomes in patients with elevated levels of the inflammatory biomarker C-reactive protein (CRP).

Key Points: 
  • The post-hoc analysisfrom arandomized, placebo-controlled 60-patient Phase 2 trial in patients with COPD showed that remestemcel-L, given in four monthly intravenous doses of 100 million cells, significantly improved respiratory and functional clinical outcomes in patients with elevated levels of the inflammatory biomarker C-reactive protein (CRP).
  • Mesoblast Chief Medical Officer Dr Fred Grossman said: The correlation between highest CRP levels and greatest degree of response to remestemcel-L suggests that the inflammatory component of the lung disease may trigger and be amenable to the immunomodulatory effects of treatment with remestemcel-L in patients with acute inflammatory conditions.
  • Six-minute-walk test in chronic obstructive pulmonary disease: minimal clinically important difference for death or hospitalization.Am J Respir Crit Care Med.2013;187:382386.
  • Remestemcel-L is also being developed for other inflammatory diseases in children and adults including moderate to severe acute respiratory distress syndrome.

Ashvattha Therapeutics Subsidiary Orpheris Announces FDA Agreement to Initiate Phase 2 Study Evaluating OP-101 in Severe COVID-19 Patients

Retrieved on: 
Thursday, May 28, 2020
Research, General Health, Pharmaceutical, Optical, Data management, Oncology, Technology, Clinical trials, Science, Biotechnology, FDA, Health, Other Science, Branches of biology, Medical specialties, Medicine, Chemical pathology, Immunology, Cell biology, Acute phase proteins, Blood tests, Inflammatory cytokine, C-reactive protein, Cytokine, Inflammation, Ashvattha Therapeutics, Orpheris

OP-101 selectively targets reactive macrophages, reducing the pro-inflammatory cytokine storm and oxidative stress in multiple animal models of inflammation.

Key Points: 
  • OP-101 selectively targets reactive macrophages, reducing the pro-inflammatory cytokine storm and oxidative stress in multiple animal models of inflammation.
  • An evaluation of reduction in pro-inflammatory markers (CRP, ferritin, and IL-6) after treatment with OP-101 is also included in the study.
  • We believe there is strong scientific rationale for the development of OP-101 to treat severe COVID-19 patients.
  • We look forward to this clinical evaluation of OP-101, as there are currently no FDA approved treatment options to treat hyperinflammation in severe COVID-19 patients.

Cerus Corporation Announces FDA PMA Supplement Submission for Pathogen-Reduced Cryoprecipitated Fibrinogen Complex

Retrieved on: 
Tuesday, May 26, 2020
Biotechnology, General Health, FDA, Medical devices, Health, Proteins, Coagulation system, Acute phase proteins, Blood proteins, Branches of biology, Fibrinogen, Food and Drug Administration, Fibrin, Dose

Cerus Corporation (Nasdaq:CERS) announced today that the Company has submitted a pre-market approval supplement (PMA-S) to the FDA for a pathogen reduced cryoprecipitated fibrinogen complex with 5-day post thaw storage.

Key Points: 
  • Cerus Corporation (Nasdaq:CERS) announced today that the Company has submitted a pre-market approval supplement (PMA-S) to the FDA for a pathogen reduced cryoprecipitated fibrinogen complex with 5-day post thaw storage.
  • Pathogen-reduced cryoprecipitated fibrinogen complex is manufactured from FDA licensed INTERCEPT plasma.
  • Cerus pathogen-reduced cryoprecipitated fibrinogen complex is designed to be stored for up to five days at room temperature after thaw and to be provided in doses enabling greater ease of use.
  • Given the 180-day review process for PMA supplements, we could potentially receive FDA approval for pathogen-reduced cryoprecipitated fibrinogen complex by the end of this calendar year.

DGAP-News: Biotest AG: Biotest achieves significant milestone by completing phase I/III clinical trial with fibrinogen

Retrieved on: 
Tuesday, May 26, 2020
Blood, Proteins, Branches of biology, Coagulation system, Acute phase proteins, Congenital disorders, Fibrinogen, Rare diseases, Congenital hypofibrinogenemia, Hypodysfibrinogenemia

In the phase I/III study, patients with congenital fibrinogen deficiency were treated with the fibrinogen concentrate (BT524) developed by Biotest in the case of acute bleeding or as prophylactic treatment before surgery.

Key Points: 
  • In the phase I/III study, patients with congenital fibrinogen deficiency were treated with the fibrinogen concentrate (BT524) developed by Biotest in the case of acute bleeding or as prophylactic treatment before surgery.
  • These patients are unable to produce functional fibrinogen themselves, or only insufficiently and are therefore dependent on the administration of external fibrinogen.
  • The prospective, open, multicentre phase I/III study investigated the pharmacokinetic properties, efficacy and safety of fibrinogen concentrate in adults and children with congenital fibrinogen deficiency.
  • Biotest is also testing the fibrinogen concentrate in this indication in the phase III trial called "ADFIRST".

ProciseDx Files 510k and Prepares for EU launch of Novel Point of Care Technology

Retrieved on: 
Tuesday, May 12, 2020
Branches of biology, Medicine, Medical specialties, Blood tests, Immunologic tests, Intensive care medicine, Acute phase proteins, Biomarkers, C-reactive protein, Förster resonance energy transfer

Procise CRP is the first of a series of 2-5 minute lab-quality tests what will be launched on the ProciseDx instrument.

Key Points: 
  • Procise CRP is the first of a series of 2-5 minute lab-quality tests what will be launched on the ProciseDx instrument.
  • "We're delighted with the robust performance we've been able to demonstrate in our CRP 510k clinical trials," said Larry Mimms, CEO and Chief Scientific Officer of ProciseDx.
  • "We believe that using FRET (Florescent Resonance Energy Transfer) technology brings real advantages in clinical practice.
  • Jacques joins ProciseDx with extensive point of care diagnostic commercialization experience, most recently at GenMark, where he was Vice President and General Manager, Europe.

Fibrinogen Market Growth Analysis to 2023 - Featuring Key Players: Shanghai XinXing Medical, CSL Behring, Greencross, Johnson & Johnson, Baxter, LFB Group, & ProFibrix BV | Radiant Insights, Inc.

Retrieved on: 
Wednesday, April 22, 2020
Blood, Proteins, Coagulation system, Acute phase proteins, Anatomy, Blood proteins, CSL Behring, Fibrinogen, Fibrin

One can cause excessive bleeding, if there is no enough fibrinogen or if the cascade is not working normally.

Key Points: 
  • One can cause excessive bleeding, if there is no enough fibrinogen or if the cascade is not working normally.
  • Animal Fibrinogen Concentrate and Human Fibrinogen Concentrate are the product type that could be explored in Fibrinogen in the forecast period.
  • The key players of Fibrinogen Market are Shanghai XinXing Medical, CSL Behring, Greencross, Baxter, Harbin Pacific Biopharmaceutical, Johnson & Johnson, Hualan Biological Engineering, LFB Group, Jiangxi Boya Bio-Pharmaceutical, ProFibrix BV (The Medicines, and Shanghai RAAS.
  • Relevantly, the report and company profiles specify the key drivers that are impacting the demand in global Fibrinogen market.

Fibrinogen Market Growth Analysis to 2023 - Featuring Key Players: Shanghai XinXing Medical, CSL Behring, Greencross, Johnson & Johnson, Baxter, LFB Group, & ProFibrix BV | Radiant Insights, Inc.

Retrieved on: 
Wednesday, April 22, 2020
Blood, Proteins, Coagulation system, Acute phase proteins, Anatomy, Blood proteins, CSL Behring, Fibrinogen, Fibrin

One can cause excessive bleeding, if there is no enough fibrinogen or if the cascade is not working normally.

Key Points: 
  • One can cause excessive bleeding, if there is no enough fibrinogen or if the cascade is not working normally.
  • Animal Fibrinogen Concentrate and Human Fibrinogen Concentrate are the product type that could be explored in Fibrinogen in the forecast period.
  • The key players of Fibrinogen Market are Shanghai XinXing Medical, CSL Behring, Greencross, Baxter, Harbin Pacific Biopharmaceutical, Johnson & Johnson, Hualan Biological Engineering, LFB Group, Jiangxi Boya Bio-Pharmaceutical, ProFibrix BV (The Medicines, and Shanghai RAAS.
  • Relevantly, the report and company profiles specify the key drivers that are impacting the demand in global Fibrinogen market.