MCP-1

Senhwa Biosciences Received US FDA IND Approval for Phase II Study of Silmitasertib in Patients with Community-Acquired Pneumonia (CAP) Associated with Viral Infection

Retrieved on: 
Tuesday, November 21, 2023
Food and Drug Administration, CCL4, Food, Influenza, CAP, IL-6, IIT, Patient, CK2, César-Joseph Bourayne, Viral, Infection, COVID-19, Therapy, MCP-1, Virus, SARS-CoV-2, Community-acquired pneumonia, Drug development, Vaccine, Pharmaceutical industry, Silmitasertib

The trial is a phase II multi-center, randomized-controlled interventional prospective study, and the purpose of this trial is to investigate whether early intervention of Silmitasertib restrains the progression of CAP by inhibiting the elevated cytokine release associated with SARS-CoV-2 and Influenza viruses.

Key Points: 
  • The trial is a phase II multi-center, randomized-controlled interventional prospective study, and the purpose of this trial is to investigate whether early intervention of Silmitasertib restrains the progression of CAP by inhibiting the elevated cytokine release associated with SARS-CoV-2 and Influenza viruses.
  • Silmitasertib works by inhibiting CK2 protein kinase, which have implicated in regulation of several signaling pathways that are important for innate immune responses.
  • "Senhwa regards this phase II as the proof-of-concept study to demonstrate Silmitasertib can be a therapeutic strategy that are not restricted to only a specific viral infection, but applicable to various viruses," said Jin-Ding Huang, CEO of Senhwa Biosciences, Inc.
  • Prior to this phase II study, Silmitasertib was investigated in two investigator-initiated trials (IIT) in the United States and has showed clinical benefits by accelerating the recovery speed in patients with moderate symptoms of COVID-19.

aTyr Pharma Presents New Data on Efzofitimod Mechanism of Action and Positive Exposure-Response at the American Thoracic Society 2023 International Conference

Retrieved on: 
Monday, May 22, 2023
Sarcoidosis, Myelocyte, Inflammation, Macrophage, Small RNA, Neuropilin, ATyr Pharma, ATS, DC, Immunoassay, ILD, IL-6, Tumor necrosis factor, Research, FC, Macrophage inflammatory protein, American Thoracic Society, Biomarker, Monocyte, Vital capacity, International Conference on Creationism, Patient, SAN, Flow cytometry, Pulmonary alveolar proteinosis, Phenotype, Safety, Convention center, Conference, MCP-1, Disease, Medical imaging, Pharmaceutical industry, Fibrosis

SAN DIEGO, May 22, 2023 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE), a clinical stage biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced that the company will present data for its lead therapeutic candidate, efzofitimod, at the American Thoracic Society (ATS) 2023 International Conference, which is scheduled to take place May 19 – 24 in Washington, DC.

Key Points: 
  • Exposure-efficacy data from Phase 1b/2a study of efzofitimod support efficacy across multiple clinically relevant endpoints in pulmonary sarcoidosis patients.
  • “We present new data showing that by binding to neuropilin-2, efzofitimod modulates immune responses through myeloid cells.
  • By targeting multiple drivers of inflammation, efzofitimod provides a differentiated approach to resolving chronic inflammation.
  • aTyr is currently conducting EFZO-FIT™, a global pivotal Phase 3 study of efzofitimod in pulmonary sarcoidosis.

Valbiotis Announces Positive Results in the Bioavailability and Mode of Action TOTUM•854 Clinical Study, Against High Blood Pressure

Retrieved on: 
Monday, January 30, 2023
Health, Clinical Trials, Research, Science, Pharmaceutical, Cardiology, Biotechnology, NOX2, Lipid, Cell, Oxidative stress, AMF, INSIGHT, Phase, Metabolomics, Radical, DSM-IV codes, American Heart Association, European Society of Cardiology, Executive Committee, Risk, Volunteering, Blood pressure, PEA, Human, Blood, Fibrinogen, BPI, Endothelium, NAFL, European Regional Development Fund, ERDF, White, Serum, Cardiovascular disease, Research and development, AHA, Development, Translational research, Metabolism, Inflammation, MCP-1, ESC, Discovery, Hypertension, Popular Executive Committee of Valencia, Disease, European, Pharmaceutical industry, Dietary supplement, Europe 1

Damage to the vascular wall is a major mechanism in the progression of high blood pressure.

Key Points: 
  • Damage to the vascular wall is a major mechanism in the progression of high blood pressure.
  • This first-in-human evidence confirms the relevance of TOTUM•854's positioning in the early stages of the disease and bodes well for the ongoing Phase II/III clinical efficacy studies in high blood pressure."
  • Mode of action tests also revealed a reduction in angiotensin I-converting enzyme (ACE1) activity, an enzyme well known in the pathophysiology of high blood pressure.
  • 3The fraction of blood remaining after all blood cells (red blood cells, leukocytes, platelets) and fibrinogen (a protein involved in coagulation) have been removed.

AIM ImmunoTech Reports Positive Safety, Tolerability and Biological Activity Data for Intranasal Ampligen® (Rintatolimod) in Healthy Subjects

Retrieved on: 
Thursday, December 8, 2022
Smallpox vaccine, Event, RNA, B cell, Immunology, Society, Chronic fatigue syndrome, CFS, Special access program, EAP, NYSE, Influenza and Other Respiratory Viruses, Pancreatic cancer, RANTES, AES, British Society for Research on Ageing, Safety, Physician, Monocyte, AIM, Degenerative disease, Erasmus MC, TNF, Vaccinia, IL-8, Chemokine, Inspectorate, ME/CFS, TLR3, PSLRA, IL-6, Infection, Patient, CXCL10, Immune system, Research, Disease, Interferon, Cancer, Severe acute respiratory syndrome coronavirus 2, COVID-19, CHDR, Granulocyte, Therapy, Vaccine, Pharmaceutical industry, Rintatolimod, MCP-1

OCALA, Fla., Dec. 08, 2022 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus, today reported that data were recently presented by Lisanne C.A. Smidt - Centre for Human Drug Research (CHDR), Leiden, the Netherlands in a poster titled, “Safety, tolerability and biological activity of repeated intranasal administration of TLR3 agonist Ampligen (Poly I:Poly C12U) in healthy subjects,” at the British Society for Immunology Congress 2022 . The data showed positive safety, tolerability and biological activity of a 13-day dosing regimen conducted in Q2 2021 for intranasal Ampligen® (rintatolimod) in healthy subjects.

Key Points: 
  • Smidt - Centre for Human Drug Research (CHDR), Leiden, the Netherlands in a poster titled, “Safety, tolerability and biological activity of repeated intranasal administration of TLR3 agonist Ampligen (Poly I:Poly C12U) in healthy subjects,” at the British Society for Immunology Congress 2022 .
  • The data showed positive safety, tolerability and biological activity of a 13-day dosing regimen conducted in Q2 2021 for intranasal Ampligen® (rintatolimod) in healthy subjects.
  • Intranasal administration of Ampligen could induce an innate mucosal immune response, thereby inhibiting respiratory viruses at the point of entry.
  • Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA.

MediciNova Receives a Notice of Allowance for a New Patent Covering MN-001 and MN-002 for the Treatment of Hypertriglyceridemia, Hypercholesterolemia, and Hyperlipoproteinemia in Canada

Retrieved on: 
Wednesday, September 14, 2022
CCR2, Canadian intellectual property law, Intellectual property, Inflammation, IPF, Multiple sclerosis, Safety, Hypercholesterolemia, LDL, Fibrosis, Risk, FDA, Hypertriglyceridemia, Blood, NASH, Neurodegeneration, Idiopathic pulmonary fibrosis, Form 10-K, Private Securities Litigation Reform Act, DCM, Non-alcoholic fatty liver disease, Diabetes, U.S. Securities and Exchange Commission, Glioblastoma, Patient, MS, MCP-1, Juntendo University, TG, Tokyo Stock Exchange, LOXL2, Triglyceride, Orphan drug, NASDAQ, Amyotrophic lateral sclerosis, Code, ALS, Security (finance), Nasdaq, GLOBE, Form 8-K, Annual report, Patent, Asthma, Failure, Interstitial cystitis, Pharmaceutical industry, Hyperlipidemia, NAFLD

Once issued, the patent maturing from this allowed patent application is expected to expire no earlier thanJuly 2034.

Key Points: 
  • Once issued, the patent maturing from this allowed patent application is expected to expire no earlier thanJuly 2034.
  • The allowed claims cover a wide range of doses and a range of different dosing frequencies.
  • Ph.D, MPH., Chief Medical Officer,MediciNova, Inc., commented, We are very pleased to receive notice that this new patent will be granted.
  • MN-001 (tipelukast) has also been granted Fast Track status and Orphan Drug designation for the treatment of idiopathic pulmonary fibrosis.

MediciNova Announces MN-001 (tipelukast) Abstract regarding Improvement of Serum Lipid Panel in Type 2 Diabetes and NAFLD Patients Accepted for Presentation at the IDF 2022 Congress, the Annual Meeting of the International Diabetes Federation

Retrieved on: 
Tuesday, August 9, 2022
FDA, Intellectual property, U.S. Securities and Exchange Commission, Cardiovascular disease, CCR2, Chronic kidney disease, CD36, Nasdaq, Hepatocyte, Risk, Tokyo Stock Exchange, Gene, Inflammation, Arachidonic acid, International Diabetes Federation, Metabolic syndrome, MS, IPF, GLOBE, Failure, Hypercholesterolemia, Private Securities Litigation Reform Act, IDF, Non-alcoholic fatty liver disease, MCP-1, Code, T2DM, Incidence, Amyotrophic lateral sclerosis, Prevalence, Congress, Security (finance), Research, LOXL2, Hypertriglyceridemia, Form 8-K, Patient, Fibrosis, Type 2 diabetes, NAFLD, PDE, Form 10-K, DCM, Neurodegeneration, NASDAQ, Idiopathic pulmonary fibrosis, Glioblastoma, Dyslipidemia, ABCG1, MD, Annual report, ALS, Multiple sclerosis, RNA transfection, Malignancy, Pharmaceutical industry

This subgroup analysis was conducted based on in-vitro research findings that MN-001 down regulated CD36 mRNA and upregulated ABCG1 mRNA.

Key Points: 
  • This subgroup analysis was conducted based on in-vitro research findings that MN-001 down regulated CD36 mRNA and upregulated ABCG1 mRNA.
  • NAFLD is considered the hepatic manifestation of metabolic syndrome; studies have reported that 50% of patients with metabolic syndrome also have NAFLD.
  • The presence of dyslipidemia (hypercholesterolemia, hypertriglyceridemia, or both) is reported in 20 - 80% of NAFLD cases.
  • Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof.

MediciNova Receives Notice of Allowance for New Patent Covering MN-001 and MN-002 for the Treatment of Fibrosis in Korea

Retrieved on: 
Wednesday, July 27, 2022
IPF, Pulmonary fibrosis, Multiple sclerosis, GLOBE, MPH, Capsule, LOXL2, PDE, 1836 U.S. Patent Office fire, Glioblastoma, U.S. Securities and Exchange Commission, Macular degeneration, Amyotrophic lateral sclerosis, Neurodegeneration, Code, Tablet, Intellectual property, Disease, Form 8-K, Private Securities Litigation Reform Act, NAFLD, Pancreas, Risk, Fibrosis, Patent, Scar, Failure, NASDAQ, DCM, Gene, Cirrhosis, MCP-1, Crohn's disease, Inflammation, MS, Viral hepatitis, ALS, FDA, Security (finance), Tokyo Stock Exchange, Patient, Annual report, Korean Intellectual Property Office, Idiopathic pulmonary fibrosis, Japan Patent Office, Non-alcoholic fatty liver disease, Nasdaq, Form 10-K, Cystic fibrosis, CCR2, Pharmaceutical industry

Once issued, the patent maturing from this allowed patent application is expected to expire no earlier thanJune 2035.

Key Points: 
  • Once issued, the patent maturing from this allowed patent application is expected to expire no earlier thanJune 2035.
  • The allowed claims cover a composition for inhibiting or treating fibrosis, excluding pulmonary fibrosis and certain types of hepatic fibrosis, using MN-001 or MN-002.
  • The allowed claims cover a wide range of doses of MN-001 (tipelukast) and MN-002 and a range of different dosing frequencies.
  • A similar patent that covers the treatment of various forms of fibrosis and fibrotic disease has already been granted by the U.S. Patent Office and theJapan Patent Office.

MediciNova Announces Initiation of a Phase 2 Trial of MN-001 (tipelukast) in NAFLD with Type 2 Diabetes Mellitus and Hypertriglyceridemia

Retrieved on: 
Tuesday, July 26, 2022
Proton, Patient, Male, IPF, Dyslipidemia, Multiple sclerosis, GLOBE, LOXL2, PDE, Malignancy, Hypertriglyceridemia, Glioblastoma, U.S. Securities and Exchange Commission, Amyotrophic lateral sclerosis, Female, Doctor of Philosophy, T2DM, Hypercholesterolemia, Neurodegeneration, Code, Cardiovascular disease, Intellectual property, Form 8-K, Incidence, Private Securities Litigation Reform Act, NAFLD, NDA, Chronic kidney disease, Fibrosis, Risk, Failure, Safety, Arachidonic acid, DCM, Gene, MCP-1, Fasting, Inflammation, MS, Metabolic syndrome, ALS, FDA, MD, Security (finance), Tokyo Stock Exchange, Nasdaq, Annual report, Week, Hepatocyte, Idiopathic pulmonary fibrosis, Non-alcoholic fatty liver disease, Form 10-K, CCR2, Prevalence, Element, Pharmaceutical industry

Kazuko Matsuda, MD, PhD, Chief Medical Officer of MediciNova, Inc., commented, "We are very pleased that this Phase 2 trial evaluating MN-001 has commenced.

Key Points: 
  • Kazuko Matsuda, MD, PhD, Chief Medical Officer of MediciNova, Inc., commented, "We are very pleased that this Phase 2 trial evaluating MN-001 has commenced.
  • MN-001 appears to reduce serum lipid profiles in patients with a dual diagnosis of NAFLD and T2DM/prediabetes with dyslipidemia.
  • This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of MN-001 (tipelukast) in patients with NAFLD, T2DM and hypertriglyceridemia.
  • The design of the Phase 2 clinical trial includes the following elements:
    Approximately 40 male and female patients, ages 21 to 75 years, in the U.S.

MediciNova Announces MN-001 (tipelukast) Research Collaboration with The Juntendo University School of Medicine in Tokyo, Japan

Retrieved on: 
Thursday, June 23, 2022
Multiple sclerosis, Nasdaq, Fibrosis, CCR2, Code, Intellectual property, Department, Security (finance), FDA, Substance dependence, Inflammation, Non-alcoholic fatty liver disease, Lipid metabolism, Amyotrophic lateral sclerosis, Gene, Juntendo University, School, Medical laboratory, NAFLD, Arachidonic acid, Medical school, U.S. Securities and Exchange Commission, Tokyo Stock Exchange, Dyslipidemia, Private Securities Litigation Reform Act, Form 8-K, Metabolic syndrome, Neurodegeneration, Annual report, LDL, MD, Hypertriglyceridemia, Failure, PDE, LOXL2, MS, Hepatocyte, IPF, Patient, DCM, Idiopathic pulmonary fibrosis, MPH, MCP-1, Form 10-K, ALS, GLOBE, Glioblastoma, Risk, Pharmaceutical industry

It has also been observed to reduce serum triglyceride levels for patients with high serum triglycerides in multiple clinical trials conducted previously.

Key Points: 
  • It has also been observed to reduce serum triglyceride levels for patients with high serum triglycerides in multiple clinical trials conducted previously.
  • Furthermore, the improvements in the serum lipid profile were more significant in the patients with type 2 diabetes/prediabetes.
  • Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof.
  • MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.

aTyr Pharma Presents Clinical Data for Efzofitimod (ATYR1923) at the American Thoracic Society 2022 International Conference

Retrieved on: 
Tuesday, May 17, 2022
FC, Tumor necrosis factor, Risk, Sarcoidosis, Private Securities Litigation Reform Act, Patient, Poster, Degenerative disease, Inflammation, Biology, Goal, Pneumonia, COVID-19, ACE, Research, MCP-1, IP-10, SAA, Forward-looking statement, Safety, Biomarker, RNA transfection, IL-6, Neuropilin, SEC, ATyr Pharma, Pharmaceutical industry

SAN DIEGO, May 17, 2022 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines from its proprietary tRNA synthetase biology platform, today announced that clinical data for efzofitimod (ATYR1923), its lead therapeutic candidate, will be presented in two posters today from 11:15AM – 1:15PM PT at the American Thoracic Society (ATS) 2022 International Conference in San Francisco, CA.

Key Points: 
  • The poster presents clinical biomarker findings from a Phase 1b/2a randomized, double-blind, placebo-controlled study of efzofitimod (ATYR1923) in patients with pulmonary sarcoidosis.
  • Efzofitimod demonstrated dose dependent control of inflammatory and sarcoidosis disease biomarkers over 24 weeks in the context of a corticosteroid taper.
  • These results are the first demonstration of efzofitimods anti-inflammatory mechanism in patients with pulmonary sarcoidosis.
  • aTyr is developing efzofitimod as a potential therapeutic for patients with fibrotic lung disease.