Aes

PRP Group Launches Anonymous Edvisors Platform to Facilitate Feedback Sessions Between Administrators and Vendors

Retrieved on: 
torsdag, maj 9, 2024
Education, Language, Risk, Human, Aes, Assistant, Feedback, Organization, Cryptocurrency

Buffalo, MN, May 09, 2024 (GLOBE NEWSWIRE) -- PRP Group , an award-winning public relations firm focusing on education, today unveiled its Anonymous Edvisors (AE) platform, which automates the logistics of feedback sessions between administrators and education vendors.

Key Points: 
  • Buffalo, MN, May 09, 2024 (GLOBE NEWSWIRE) -- PRP Group , an award-winning public relations firm focusing on education, today unveiled its Anonymous Edvisors (AE) platform, which automates the logistics of feedback sessions between administrators and education vendors.
  • Sessions currently underway in the platform include a CAO, a superintendent, and an edtech director who are engaging anonymously with vendors.
  • The platform removes all identifiable information and anonymizes the administrators’ identities, affording a better opportunity for unfiltered and unbiased feedback without the risk of conflicts of interest.
  • Anonymous Edvisors was launched as a way to facilitate more meaningful interactions between the organizations and administrators serving education, and I am excited for our new platform to enhance that process.

Inmagene Reports Positive Interim Results from Phase 2a Trial of IMG-007, a Nondepleting Anti-OX40 Monoclonal Antibody with an Extended Half-life, for the Treatment of Atopic Dermatitis

Retrieved on: 
måndag, maj 6, 2024
Șaeș, Patient, Outline of health sciences, Safety, Pharmacokinetics, BSA, Half-life, OX40, Disease, ADCC, Week, Aes, Chills, AA, Atopic dermatitis, I&I, SAN

Treatment with IMG-007, the only clinical-stage nondepleting anti-OX40 monoclonal antibody (mAb), led to rapid, marked, and durable improvement of skin signs in patients with atopic dermatitis (AD).

Key Points: 
  • Treatment with IMG-007, the only clinical-stage nondepleting anti-OX40 monoclonal antibody (mAb), led to rapid, marked, and durable improvement of skin signs in patients with atopic dermatitis (AD).
  • IMG-007 is a nondepleting anti-OX40 mAb, bioengineered to have a silenced antibody-dependent cellular cytotoxicity (ADCC) function and a prolonged half-life.
  • The Phase 2a trial ( NCT05984784 ) evaluates the safety, pharmacokinetics, and efficacy of IMG-007 in adult patients with moderate-to-severe AD who had inadequate response to and/or intolerant of topical therapies.
  • There were no serious adverse events (SAEs), and no adverse events (AEs) leading to treatment discontinuation, and no treatment-related AEs.

Neurogene Presents Favorable Safety Data from Phase 1/2 Trial of NGN-401 Gene Therapy for Rett Syndrome during ASGCT Annual Meeting

Retrieved on: 
tisdag, maj 7, 2024
Health, Neurology, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Șaeș, MECP2, Hospital, Safety, ICV, Rett syndrome, AAV, Cohort, Patient, Baylor College of Medicine, Pediatrics, Aes, Toxicity, Associate, Baylor University, Pharmaceutical industry

All adverse events (AEs) related to NGN-401 have been mild, or Grade 1, and transient or resolving.

Key Points: 
  • All adverse events (AEs) related to NGN-401 have been mild, or Grade 1, and transient or resolving.
  • Most AEs are known potential risks of adeno-associated virus (AAV), including asymptomatic laboratory value changes.
  • “Gene therapy has the potential to address the underlying cause of Rett syndrome with a one-time treatment, and these interim safety data from the NGN-401 trial provide an important milestone on the path to realizing its potential for patients.
  • I look forward to the continued work in conducting the trial as we evaluate NGN-401’s safety and efficacy.”
    The presentation by Dr. Suter is available as an ePoster on the ASGCT Annual Meeting platform and https://ir.neurogene.com .

Cybin Provides Corporate Update and Highlights Upcoming Clinical Milestones 

Retrieved on: 
måndag, maj 6, 2024
Biotechnology, FDA, Mental Health, Health, Pharmaceutical, Clinical trial, Safety, Depression, GAD, DSM-IV codes, IM, BTD, Aes, Inc., Anxiety, Tryptamine, MDD, Prevalence, Open access, Pharmaceutical industry

Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation psychedelic-based treatment options, provides a corporate update highlighting recent clinical accomplishments and key upcoming catalysts across its development pipeline.

Key Points: 
  • Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation psychedelic-based treatment options, provides a corporate update highlighting recent clinical accomplishments and key upcoming catalysts across its development pipeline.
  • Our team is dedicated to turning the tide of the mental health crisis through our clinical-stage programs,” said Doug Drysdale, Chief Executive Officer of Cybin.
  • The BTD by the FDA validates CYB003's potential to show significant clinical improvements over existing treatments based on preliminary results and serves to expedite CYB003’s development pathway towards commercialization.
  • Cybin is also developing EMBARK for Clinical Trials (“EMBARKCT”), a scalable model of psychedelic facilitation training that will enable the Company to effectively screen, qualify, and train facilitators to participate in future pivotal trials.

Barinthus Bio Announces Topline Data from Phase 1b/2 APOLLO Trial of VTP-200 in Persistent High-Risk Human Papillomavirus (HPV) Infections

Retrieved on: 
torsdag, april 18, 2024
Șaeș, Cancer, Safety, Woman, Month, Group 2, HPV, Aes, APOLLO, Immune system, Autoimmunity, Ageing, Birth control

Pooled data from the five different active dose groups demonstrated no statistically significant improvement in either hrHPV or cervical lesion clearance in comparison to the placebo group.

Key Points: 
  • Pooled data from the five different active dose groups demonstrated no statistically significant improvement in either hrHPV or cervical lesion clearance in comparison to the placebo group.
  • “This was our first in-human, dose-ranging trial of VTP-200 in women with hrHPV-associated low-grade cervical lesions, who currently don’t have any treatment option until progression to high-grade lesions,” said Bill Enright, Chief Executive Officer of Barinthus Bio.
  • “However, these differences compared to placebo were not statistically significant given that the trial was not powered for individual dose group comparisons.
  • Further analyses are ongoing, mostly focusing on immunological responses and we plan to share the detailed results in due course.”

AskBio presents 18-month Phase Ib trial results of AB-1005 gene therapy for patients with Parkinson’s disease

Retrieved on: 
tisdag, april 16, 2024
American Academy, Șaeș, Political moderate, Bayer, Safety, Patient, Aes, Putamen, Clinical trial, PD, Pharmaceutical industry

These included headache, tremor, dyskinesia, arthralgia, musculoskeletal chest pain, fatigue, COVID-19, and magnetic resonance imaging (MRI) abnormalities.

Key Points: 
  • These included headache, tremor, dyskinesia, arthralgia, musculoskeletal chest pain, fatigue, COVID-19, and magnetic resonance imaging (MRI) abnormalities.
  • Bilateral infusions of AB-1005 within the putamen (up to 1.8 mL) were well tolerated, with no SAEs associated with the investigational gene therapy or contrast agent.
  • Neurosurgical delivery of AB-1005 resulted in putamen coverage of 63% ± 2%, exceeding the goal of greater than 50% coverage with AB-1005.
  • “While much remains to be done, we recognize with increasing confidence the potential of AB-1005 to provide a transformative impact for patients in the future.”

Pulmocide Announces Successful Results from the OPERA-S Study: a Phase 2 Safety Study with Inhaled Opelconazole

Retrieved on: 
måndag, april 15, 2024
University, Safety, Risk, Nausea, ICU, Fungal infection, Incidence, Patient, SOC, Fusarium, Aes, Clutch (eggs), Standard of care, Pharmaceutical industry

LONDON, April 15, 2024 (GLOBE NEWSWIRE) --  Pulmocide Ltd., (“the Company”) a late-stage biopharmaceutical company developing novel inhaled therapies for patients suffering from serious acute and chronic respiratory diseases, today announced topline results from the OPERA-S study: a Phase 2 safety and tolerability study in lung transplant patients receiving inhaled opelconazole monotherapy as prophylaxis against pulmonary aspergillosis. Opelconazole is an investigational inhaled triazole antifungal being developed to prevent and treat pulmonary aspergillosis. In this study, opelconazole was generally well tolerated with a low incidence of drug-related adverse events (AEs) and a low incidence of treatment-limiting respiratory AEs. Importantly, there were no dose reductions or discontinuations of opelconazole prophylaxis or of immunosuppressant medications due to opelconazole-related drug-drug interactions (DDIs). Despite the expected small numbers, there was evidence of prevention of pulmonary aspergillosis and of eradication in the lungs of both Aspergillus and Candida colonization with opelconazole monotherapy.

Key Points: 
  • In this study, opelconazole was generally well tolerated with a low incidence of drug-related adverse events (AEs) and a low incidence of treatment-limiting respiratory AEs.
  • Importantly, there were no dose reductions or discontinuations of opelconazole prophylaxis or of immunosuppressant medications due to opelconazole-related drug-drug interactions (DDIs).
  • Importantly, respiratory AEs related to opelconazole were rarely treatment-limiting, leading to discontinuation in two out of 65 opelconazole patients.
  • Three patients in the study died: one in the opelconazole group (1.5%) and two in the SOC group (6%).

Renovion Announces Positive Top-Line Results from Phase 2 CLIMB Study of ARINA-1 (RVN-301) in Patients with Non-Cystic Fibrosis Bronchiectasis

Retrieved on: 
tisdag, april 30, 2024
Health, Infectious Diseases, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Hemoptysis, MCID, Inflammation, Safety, Mucus, QOL, Professor, Bronchiectasis, MD, Doctor of Philosophy, Conference, Mycobacterium, Sputum, Periodic breathing, Urinary tract infection, CAAT, Disease, Chronic cough, Patient, Principal, Aes, Diagnosis, Inc., ITT, American Thoracic Society, Quality of life, Asthma, Bronchitis, National Jewish Health, Division, Infection, COPD, Pharmaceutical industry

The CLIMB study was a randomized double-blind placebo-controlled study to assess the safety and efficacy of ARINA-1 in NCFBE.

Key Points: 
  • The CLIMB study was a randomized double-blind placebo-controlled study to assess the safety and efficacy of ARINA-1 in NCFBE.
  • Participants were randomized (7:3, treatment:placebo), and 40 participants completed the study, with 29 completing in the ARINA-1 arm and 11 in the placebo (0.9% saline) arm.
  • Topline results from the intention-to-treat (ITT) population demonstrate that ARINA-1 is safe and improves quality of life (QOL) in individuals with NCFBE who experience mucus symptoms.
  • Renovion will discuss study results at the American Thoracic Society Meeting (May 17-22) and present findings at the World Bronchiectasis Conference (July 4-6) in Dundee, Scotland.

Virtual Incision Announces Publication of Data from its U.S. Investigational Device Exemption Study in the Clinical Journal, Diseases of Colon and Rectum

Retrieved on: 
tisdag, april 30, 2024
Medical Devices, Health, Surgery, Health Technology, Clinical Trials, General Health, Colorectal surgery, FDA, Lankenau Medical Center, Learning, Safety, Food, IDE, Surgeon, MD, Trial of the century, Doctor of Philosophy, FACS, MIRA, Incidence, Patient, De novo, Aes, Investigational device exemption, Quality of life

Virtual Incision Corporation , the developer of the MIRA™ Surgical System (MIRA), today announced data from its Investigational Device Exemption (IDE) clinical study has been published in Diseases of Colon and Rectum .

Key Points: 
  • Virtual Incision Corporation , the developer of the MIRA™ Surgical System (MIRA), today announced data from its Investigational Device Exemption (IDE) clinical study has been published in Diseases of Colon and Rectum .
  • The study was designed to assess the safety and efficacy of MIRA, the world’s first miniaturized robotic-assisted surgery device, in adults undergoing colectomy procedures.
  • Results were provided to the Food and Drug Administration (FDA) as part of the submission to support the de novo marketing authorization of the device.
  • The data demonstrated the following results:
    The primary efficacy endpoint, the successful completion of pre-defined procedural steps without conversion to open surgery, was met.

Merck Announces Positive Data for V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults

Retrieved on: 
måndag, april 29, 2024
Health, Infectious Diseases, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, MSD, Infection, FDA, Safety, 10A, Merck & Co., Epidemiology, Pediatrics, Abstract, Vaccine, PDUFA, Streptococcus, Patient, 9N, EMA, Medicine, 20A, Aes, Emory University, OPA, PCV20, Leucauge, European Medicines Agency, Food, MRK, Global health

The trial evaluated the immunogenicity, tolerability and safety of V116 compared to PPSV23 (pneumococcal vaccine, polyvalent [23-valent]) in adults 50 years of age and older who had not previously received a pneumococcal vaccine.

Key Points: 
  • The trial evaluated the immunogenicity, tolerability and safety of V116 compared to PPSV23 (pneumococcal vaccine, polyvalent [23-valent]) in adults 50 years of age and older who had not previously received a pneumococcal vaccine.
  • V116 is currently under review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
  • The FDA granted V116 priority review with a Prescription Drug User Fee Act (PDUFA), or target action date, of June 17, 2024.
  • V116 is specifically designed to help protect adults from invasive pneumococcal disease; the serotypes in V116 account for approximately 83% of adult invasive pneumococcal disease in individuals 65 and older, according to U.S. Centers for Disease Control and Prevention data from 2018-2021.