Skin manifestations of sarcoidosis

Cabaletta Bio Receives FDA Clearance of IND Application for Treatment of Systemic Sclerosis with CABA-201

Retrieved on: 
Monday, October 2, 2023
Rheumatology, Food, Survival, Woman, Infertility, Skin manifestations of sarcoidosis, Lupus, Scleroderma, Myositis, CAR, Investigational New Drug, Patient, Risk, Autoimmune disease, Diagnosis, Mortality, American College, FDA, Pulmonary hypertension, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Systemic scleroderma, Skin, Autoantibody, Pharmaceutical industry

PHILADELPHIA, Oct. 02, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the Company’s third Investigational New Drug (IND) application for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, has been allowed to proceed by the U.S. Food and Drug Administration (FDA) for a Phase 1/2 study in patients with systemic sclerosis (SSc). The Company plans to initiate a Phase 1/2 clinical trial of CABA-201 across two parallel SSc cohorts – one cohort of six patients with severe skin manifestations and a separate cohort of six patients with severe organ involvement associated with systemic sclerosis. Consistent with the previously announced CABA-201 IND clearances for lupus and myositis, the starting dose for the trial, 1 x 106 cells/kg, was informed by the high degree of similarity between CABA-201 and the CD19-CAR T construct administered to a patient with severe, diffuse SSc in the recent Annals of Rheumatic Diseases publication.

Key Points: 
  • The Company plans to initiate a Phase 1/2 clinical trial of CABA-201 across two parallel SSc cohorts – one cohort of six patients with severe skin manifestations and a separate cohort of six patients with severe organ involvement associated with systemic sclerosis.
  • SSc affects approximately 88,000 patients in the U.S., and typically affects middle-aged individuals, particularly women.
  • Standard treatment options, which have modest effects, include generalized immunosuppressive agents or drugs targeted to specific symptomatic manifestations.
  • Due to the lack of adequate treatments, the risk of mortality in systemic sclerosis remains high, with an average survival of approximately 12 years following diagnosis.

Sermo Barometer Finds 3 in 5 Physicians Report Social Media Has Hurt the Ability to Manage Patients' Cosmetic Treatment Expectations

Retrieved on: 
Tuesday, April 25, 2023
Social Media, Health Technology, Technology, Public Relations, Investor Relations, Surgery, Communications, General Health, Professional Services, Women, Teens, Men, Artificial Intelligence, DEI (Diversity, Equity and Inclusion), Consumer, Internet, Health, Social media, Dermatology, Trust, Longevity, Atopic dermatitis, Multimedia, Skin manifestations of sarcoidosis, HCP, Ability, Patient, Physician, Vertically transmitted infection, DEI, Safety, Nursing, Pharmaceutical industry, Electric motor, Veterinary medicine, Sermo

59% of the physicians surveyed feel that social media has hurt the effort to manage patients' expectations with cosmetic treatments.

Key Points: 
  • 59% of the physicians surveyed feel that social media has hurt the effort to manage patients' expectations with cosmetic treatments.
  • View the full release here: https://www.businesswire.com/news/home/20230425005488/en/
    Sermo Barometer Finds 3 in 5 Physicians Report Social Media Has Hurt the Ability to Manage Patients' Cosmetic Treatment Expectations (Photo: Business Wire)
    Practices are being inundated with patients bringing up cosmetic trends seen on social media with 80% of surveyed dermatology-focused physicians reporting that their patients bring up these trends frequently to occasionally and only 2% of physicians reported that patients have never brought up a trending social media cosmetic treatment in their practice.
  • “Dermatologists feel they are in a no-win battle against unrealistic expectations of cosmetic treatment capabilities being presented on consumer-facing social media channels,” says Dr. Roya Azadi, Medical Director at Concord Clinic and Elite Medical + Longevity and Sermo Medical Advisory Board Member.
  • The survey included more than 300 global physicians ranging from dermatologists, dermatology-focused surgeons, and primary care physicians who treat medical and cosmetic dermatology conditions who were surveyed between April 5-10, 2023.

Kezar Life Sciences Presents Positive Complete Results from the MISSION Phase 2 Trial Evaluating Zetomipzomib in Lupus Nephritis at the American College of Rheumatology Convergence 2022

Retrieved on: 
Monday, November 14, 2022
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, EOS, Patient, Clinical trial, Plasma protein binding, Week, CD163, ORR, Lupus, EGFR, Dialysis, American College of Rheumatology, American College, DNA, UPCR, Kidney, Lupus nephritis, Death, Disease, Safety, Immune system, Degenerative disease, CRR, ACR, Inflammation, Skin manifestations of sarcoidosis, Chronic kidney disease, Immunosuppression, SLE, EOT, Biomarker, Diagnosis, Phase 1, Risk, Sec61, Proteinuria, Expressway Authority of Thailand, Pharmaceutical industry, Aluminium, Medical imaging, Synthetic oil, Medical device, LN

The MISSION Phase 2 clinical trial was an open-label study designed to demonstrate the responder rate of zetomipzomib in patients with active LN.

Key Points: 
  • The MISSION Phase 2 clinical trial was an open-label study designed to demonstrate the responder rate of zetomipzomib in patients with active LN.
  • Patients in the MISSION Phase 2 clinical trial received zetomipzomib without induction therapy, which represents a significant difference from other recently published clinical trials in LN.
  • In the MISSION Phase 2 clinical trial, 17 of 21 enrolled patients reached end-of-treatment at Week 25 and end-of-study at Week 37.
  • Zetomipzomib, its lead development asset, is a selective immunoproteasome inhibitor has completed a Phase 2 clinical trial in lupus nephritis.

Statera Biopharma Submits Phase 1 Clinical Trial Protocol to FDA for Investigational Treatment of Long-Haul COVID-19

Retrieved on: 
Wednesday, March 2, 2022
Risk, Entolimod, Efficacy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Infection, COVID, HIV disease progression rates, Veni, vidi, vici, Adult, GLOBE, TLR9, Virus, TLR5, Food, Antibody, Safety, Health status of Asian Americans, Pancreatic cancer, TLR4, FDA, Randomness, Fibromyalgia, Homeostasis, Headache, Meta-analysis, SEC, Company, Fatigue, Budget, COVID-19, TLR, Cancer, Inflammation, Autoimmunity, Multiple sclerosis, Symptoms of COVID-19, Cognition, Nasdaq, Severe acute respiratory syndrome coronavirus 2, Brain, Systematic review, Skin manifestations of sarcoidosis, Pharmaceutical industry, Vaccine, Patient, PASC

Submitting this study protocol to the FDA is a critical milestone in the development of our COVID-19 program, said Michael K. Handley, President and Chief Executive Officer, Statera Biopharma.

Key Points: 
  • Submitting this study protocol to the FDA is a critical milestone in the development of our COVID-19 program, said Michael K. Handley, President and Chief Executive Officer, Statera Biopharma.
  • With STAT-205 Statera looks to potentially offer a promising treatment approach to those patients facing the long-lasting burden of the illness.
  • In addition, the study will evaluate the efficacy of STAT-205 compared to placebo for cognition improvement in patients, as well as safety of the therapy.
  • STAT-205 for acute COVID is currently being evaluated in a Phase 1 clinical trial in adult patients with mild COVID-19 who are at high risk of disease progression.

Mallinckrodt Presents Interim Results on Real World Use of Extracorporeal Photopheresis (ECP) in Heart Transplant Patients in a Late-Breaking Presentation at the 20th Congress of the European Society for Organ Transplantation (ESOT)

Retrieved on: 
Thursday, September 2, 2021
Patient, Neurology, Degenerative disease, Rheumatology, Risk, International Society for Heart and Lung Transplantation, Graft-versus-host disease, PR, Annual report, NYHA, Transplant, Antibody, U.S. Securities and Exchange Commission, Blood, Heart transplantation, AMR, Congress, Immunomodulation, T-cell lymphoma, Skin manifestations of sarcoidosis, ECP, SEC, CAV, CTCL, Autoimmunity, Hypotension, Investor relations, Safety, Education, Knowledge, Analgesic, Nephrology, Organ transplantation, Trial of the century, Research, Ajman Specialty General Hospital, Immunotherapy, ACR, Ophthalmology, European Society for Primary Immunodeficiencies, New York Heart Association Functional Classification, Surgery, International Society, Lung transplantation, Dietary supplement, Dentistry, Health insurance, Medical imaging, Pharmaceutical industry

DUBLIN, Sept. 2, 2021 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKKQ), a global biopharmaceutical company, announced today interim results1 from a retrospective, explorative, single-arm, pan-European multicenter study to evaluate the real world use of extracorporeal photopheresis (ECP) and therapy-related outcomes in heart transplant patients. The first results from the largest known study of ECP in heart transplantation patients were reported during a late-breaking oral presentation at the 20th Congress of the European Society for Organ Transplantation (ESOT) in Milan, Italy.

Key Points: 
  • The first results from the largest known study of ECP in heart transplantation patients were reported during a late-breaking oral presentation at the 20th Congress of the European Society for Organ Transplantation (ESOT) in Milan, Italy.
  • Of the 71 patient charts examined, 51 patients (72 percent) were no longer receiving ECP treatment and treatment was ongoing for 20 patients (28 percent).
  • The remaining 19 patients (40 percent) showed stable graft function at the end of ECP treatment.
  • The study relied on real world medical charts which could be missing data or may have used site-specific measurement schedules and procedures.