Myocarditis

Cardiol Therapeutics Announces Year-End 2023 Update on Operations

Retrieved on: 
Tuesday, April 2, 2024
Hypertrophy, Heart, CRDL, Patient, Mayo Clinic, PPAR, Agent handling, Cleveland Clinic, Fibrosis, European, Therapy, Myocarditis, Analysis, American Heart Association, Human, Massachusetts General Hospital, Pericarditis, MMT, Heart failure, American College, Safety, ODD, Cardiology, Clinical professor, Disease, Pericardium, Research, World Heart Federation, Management, University, Death, Pericardial effusion, Maverick, Reactive oxygen species, TSX, Priority review, FDA, Conversation, Financial statement, Inflammation, Fast Track, Calcium, Wound healing, API, Pharmaceutical industry

"Cardiol Therapeutics made important progress in 2023 and early 2024 as we pursued our primary objective of providing new therapeutic options to patients with poorly served heart diseases," said David Elsley, President and Chief Executive Officer of Cardiol Therapeutics.

Key Points: 
  • "Cardiol Therapeutics made important progress in 2023 and early 2024 as we pursued our primary objective of providing new therapeutic options to patients with poorly served heart diseases," said David Elsley, President and Chief Executive Officer of Cardiol Therapeutics.
  • In January 2023, Cardiol announced the first patient had been enrolled in the Company's Phase II open-label pilot study ("MAvERIC-Pilot") investigating the tolerance, safety, and efficacy of CardiolRx™ in patients with recurrent pericarditis.
  • In November 2023, Cardiol announced that it had exceeded 50% of the patient enrollment target for the MAvERIC-Pilot study.
  • In January 2024, Cardiol announced that ARCHER had exceeded 50% patient enrollment and was progressing ahead of the original study timeline.

Cardiol Therapeutics Granted Orphan Drug Designation for its Lead Drug Candidate for the Treatment of Pericarditis

Retrieved on: 
Thursday, February 15, 2024
Fast Track, Recurrence, Scar, Inflammation, FDA, Quality of life, TSX, C-reactive protein, Myocarditis, Pericardial fluid, Pericarditis, Viral, CRDL, ODD, Safety, Pericardium, Therapy, Chronic pain, Fatigue, Length of stay, Patient, News, Disease, Heart, Hospital, Research, NRS, Priority review, Pharmaceutical industry

Designation Based on Pre-Clinical Data and Initial Clinical Data from the Company's MAvERIC-Pilot Phase II Study

Key Points: 
  • Toronto, Ontario--(Newsfile Corp. - February 15, 2024) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, announces that the United States Food and Drug Administration ("FDA") has granted Orphan Drug Designation ("ODD") for the Company's lead small molecule drug candidate for the treatment of pericarditis, which includes recurrent pericarditis.
  • MAvERIC-Pilot (NCT05494788) is a Phase II open-label pilot study investigating the tolerance, safety, and effect of CardiolRx™ administered to patients with recurrent pericarditis.
  • The NRS is a validated clinical tool employed across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis.
  • The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is costly and is primarily used as a third-line intervention.

Cardiol Therapeutics Announces it has Exceeded 50% Enrollment in its Phase II ARCHER Trial in Acute Myocarditis

Retrieved on: 
Tuesday, January 9, 2024
Myocarditis, Patient, European, Therapy, Research, Viral disease, Survival, Facial muscles, Fatigue, ARCHER, Heart failure, Freedom, Lightheadedness, Prognosis, Rest, Arrhythmia, Risk, Cancer, TSX, Arthralgia, Disease, Safety, Fever, Genetically modified bacteria, FDA, Inflammation, Biomarker, Marketing, Messenger, Clinical trial, Headache, Chest pain, CRDL, Pharmaceutical industry

Results from the ARCHER trial will assist in further understanding the therapeutic potential of CardiolRx™ and will complement the important clinical data from our ongoing MAvERIC-Pilot Phase II study in patients presenting with recurrent pericarditis."

Key Points: 
  • Results from the ARCHER trial will assist in further understanding the therapeutic potential of CardiolRx™ and will complement the important clinical data from our ongoing MAvERIC-Pilot Phase II study in patients presenting with recurrent pericarditis."
  • The ARCHER trial has been designed in collaboration with an independent steering committee comprising distinguished thought leaders in heart failure and myocarditis from international centers of excellence.
  • The trial is expected to enroll 100 patients at pre-eminent cardiovascular research centers in North America, France, Brazil, and Israel.
  • Orphan drug designation programs were established to provide life sciences companies with incentives to develop new therapies for rare diseases.

Human medicines European public assessment report (EPAR): Nuvaxovid, COVID-19 Vaccine (recombinant, adjuvanted), Date of authorisation: 20/12/2021, Revision: 11, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
People, Marketing, Immunodeficiency, INN, Risk, Sensation, Messenger, Nausea, RMP, Alpha, Myocarditis, Vaccination, Heart, Inflammation, Assessment, SARS, Fever, Anatomy, Paresthesia, IIA, Hypoesthesia, Skin, COVID-19 vaccine, Fatigue, ATC, Red, Pain, Ageing, Republic, Omicron, Allergy, Tenderness, Pregnancy, Safety, Medical Subject Headings, Group, Immune system, Antibody, EMA, International, Injection, Language, Select, Patient, Originality, Vomiting, Pericarditis, Anaphylaxis, System, Vaccine, Headache, Clinical trial, Swelling, Temperature, COVID-19, European Medicines Agency, SARS-CoV-2, Rash

Human medicines European public assessment report (EPAR): Nuvaxovid, COVID-19 Vaccine (recombinant, adjuvanted), Date of authorisation: 20/12/2021, Revision: 11, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Nuvaxovid, COVID-19 Vaccine (recombinant, adjuvanted), Date of authorisation: 20/12/2021, Revision: 11, Status: Authorised

Human medicines European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna), COVID-19 mRNA vaccine,elasomeran,elasomeran / imelasomeran,elasomeran / davesomeran,andusomeran, Date of authorisation: 06/01/2021, Revision: 41[...]

Retrieved on: 
Tuesday, January 2, 2024
People, Marketing, Immunodeficiency, INN, Risk, Woman, Sensation, COVID 19, Messenger, Nausea, Myocarditis, DNA, Erythema multiforme, Vaccination, Heart, Inflammation, COVID, Obesity, Liver disease, Anatomy, Paresthesia, IIA, Skin, Hypoesthesia, Chills, Diarrhea, COVID-19 vaccine, Fever, Fatigue, Infection, ATC, Pain, Palsy, Disease, Ageing, Profile, Omicron, Allergy, Pregnancy, HIV, Thigh, Safety, Somnolence, RNA, Medical Subject Headings, Group, Immune system, HIV/AIDS, Antibody, International, Injection, Crying, Language, Dizziness, Select, Patient, Vomiting, Pericarditis, Anaphylaxis, Arm, System, Vaccine, Diabetes, Headache, Abdominal pain, Clinical trial, Swelling, Hypersensitivity, Irritability, Temperature, COVID-19, European Medicines Agency, Face, Cell, Miscarriage, Rash

Human medicines European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna), COVID-19 mRNA vaccine,elasomeran,elasomeran / imelasomeran,elasomeran / davesomeran,andusomeran, Date of authorisation: 06/01/2021, Revision: 41, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna), COVID-19 mRNA vaccine,elasomeran,elasomeran / imelasomeran,elasomeran / davesomeran,andusomeran, Date of authorisation: 06/01/2021, Revision: 41, Status: Authorised

DNA Contamination of COVID Vaccines Explored in Journal of American Physicians and Surgeons

Retrieved on: 
Monday, December 11, 2023
Senate, AAPS, Plasmid, Pfizer, COVID-19 vaccine, Food, Physician, Cell nucleus, Messenger, Research, FDA, B cell, Myocarditis, DNA, PCR, COVID-19, Cancer, Polymerase chain reaction, Genome, Patient, Journal, Vaccine

“The plasmid DNA contamination theory is not a sensational internet rumor, but a reality-based hypothesis prompted by standard laboratory research performed by professional researchers,” she writes.

Key Points: 
  • “The plasmid DNA contamination theory is not a sensational internet rumor, but a reality-based hypothesis prompted by standard laboratory research performed by professional researchers,” she writes.
  • The Pfizer mRNA vaccine used in clinical trials employed a polymerase chain reaction (PCR) process to make the DNA that coded for the mRNA (Process 1).
  • But scaling up production to make millions of doses used plasmids, small circular pieces of DNA in bacterial cells (Process 2).
  • The Journal of American Physicians and Surgeons is published by the Association of American Physicians and Surgeons (AAPS) , a national organization representing physicians in all specialties since 1943.

Replimune Shares Initial Primary Analysis Results from CERPASS Clinical Trial in Advanced Cutaneous Squamous Cell Carcinoma and Presents New Data from IGNYTE Clinical Trial of RP1 in Anti-PD1 Failed Melanoma and Non-Melanoma Skin Cancers

Retrieved on: 
Tuesday, December 5, 2023
Chills, CRS, Melanoma, RP1, CRC, Food, Melanoma Research, RECIST, NMSC, Transplant, Diarrhea, FDA, Cytokine release syndrome, Colorectal cancer, SCCHN, Type, RP3, CRR, Fatigue, Headache, Nausea, Itch, Myocarditis, Incidence, Nivolumab, Influenza-like illness, Research, Clinical trial, Injection site reaction, Myalgia, CSCC, Skin cancer, HCC, Weakness, Society, Head, Appetite, RP2, Regeneron Pharmaceuticals, Carcinoma, Investment, Webcast, Patient, Lipase, Angiosarcoma, MCC, Vomiting, Neck, Uveal melanoma, Rash, BLA, Pharmaceutical industry

The CERPASS study was conducted under a Master Clinical Trial Collaboration and Supply Agreement with Regeneron Pharmaceuticals.

Key Points: 
  • The CERPASS study was conducted under a Master Clinical Trial Collaboration and Supply Agreement with Regeneron Pharmaceuticals.
  • The ORR was comparable between the two study groups (52.5% for RP1 plus cemiplimab vs. 51.4% for cemiplimab alone, p=0.692).
  • The registration directed anti-PD1 failed melanoma cohort from the IGNYTE clinical trial includes 140 patients and completed enrollment earlier this year.
  • RP1 monotherapy was well tolerated, and the safety profile was similar to that observed in non-immunocompromised patients with advanced skin cancers.

Artificial Organs Global Market Report 2023: A Potential $17.7 Billion Opportunity by 2027 - Benefits of Artificial Organs Over Traditional Transplants Drive Market Expansion - ResearchAndMarkets.com

Retrieved on: 
Monday, November 13, 2023
Hospitals, Health, Surgery, Medical Supplies, Kidney disease, COPD, Artificial organ, Prevalence, Cardiomyopathy, Investment, Liver cancer, Pelvic floor dysfunction, End organ damage, Idiopathic pulmonary fibrosis, Pulmonary hypertension, Viral, Inflammation, Chronic obstructive pulmonary disease, Blood, Organ transplantation, Ageing, Infection, Myocarditis, Growth, Cystic fibrosis, Moyamoya disease, Organic, Accident, Sonova, LivaNova, Smoking, Blood pressure, Aquaculture, Dentistry

This report is a comprehensive study of the global artificial organs market.

Key Points: 
  • This report is a comprehensive study of the global artificial organs market.
  • It describes the artificial organs market, segmented by product type and region.
  • Based on product type, the market is segmented into artificial hearts, artificial kidneys, artificial lungs, artificial pancreases, and cochlear implants.
  • Emerge more prepared and stay at the forefront of the global artificial organs market.

Cardiol Therapeutics Announces It Has Exceeded 50% Enrollment in Its Phase II MAvERIC-Pilot Study in Recurrent Pericarditis

Retrieved on: 
Wednesday, November 1, 2023
CRDL, C-reactive protein, Heart, Pericardial effusion, Chronic pain, MD, NRS, IL-6, Pericarditis, American Heart Association, Cytokine, Research, Inflammation, Myocarditis, Quality of life, Disease, Cleveland, Recurrence, Virginia Commonwealth University, Agent handling, Safety, Therapy, Cleveland Clinic, Patient, Juan Carlos Ferrero, TSX, Pharmaceutical industry

"Recurrent pericarditis is a debilitating inflammatory heart disease associated with symptoms that adversely affect quality of life and physical activity.

Key Points: 
  • "Recurrent pericarditis is a debilitating inflammatory heart disease associated with symptoms that adversely affect quality of life and physical activity.
  • MAvERIC-Pilot is enrolling 25 patients at medical research centers in the United States that specialize in pericarditis care.
  • The NRS is a validated clinical tool employed across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis.
  • Pre-clinical data adding to the strong scientific basis for investigating CardiolRx™ clinically in recurrent pericarditis were presented at the American Heart Association Scientific Sessions 2022.

ESMO 2023: Agenus’ Botensilimab/Balstilimab Combination Delivers Durable Responses across Multiple Sarcoma Subtypes

Retrieved on: 
Saturday, October 21, 2023
Science, Other Science, Biotechnology, Research, Oncology, General Health, Health, Other Health, Patient, University of Colorado School of Medicine, Pneumonitis, Hypophysitis, ESMO, Biomarker, Clinical research, Congress, European Society for Medical Oncology, BAL, MD, BOT, Inc., Cancer, Sarcoma, Immunotherapy, University, Anschutz Medical Campus, Leiomyosarcoma, Hepatitis, Safety, Myocarditis, Pharmaceutical industry, Medical imaging

The results were presented in an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2023.

Key Points: 
  • The results were presented in an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2023.
  • Relapsed/refractory sarcoma represents a significant unmet medical need where existing standard of care options and previous immunotherapies have shown limited activity.
  • The sarcoma cohort presented is part of a larger phase 1b study evaluating the safety, efficacy, and dose optimization of BOT alone and in combination with BAL in multiple advanced solid tumors.
  • "Notably, we observed several durable responses extending past one year, including patients with visceral angiosarcoma, which is traditionally unresponsive to immunotherapy, as well as other cold subtypes like leiomyosarcoma.