NIHR

GRI Bio Receives MHRA Authorization to Conduct Phase 2a Biomarker Study Evaluating GRI-0621 in the United Kingdom

Retrieved on: 
Monday, March 4, 2024

LA JOLLA, CA, March 04, 2024 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced the authorization of its Clinical Trial Application (CTA) by the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF in the UK.

Key Points: 
  • The MHRA is the UK regulatory authority, a government agency, for medicines and medical devices.
  • The MHRA is responsible for the regulation of medicines and medical devices and equipment used in healthcare and the investigation of harmful incidents.
  • “We are pleased to receive authorization from the MHRA and take a step in the global expansion of our clinical development for GRI-0621.
  • We are focused on driving this program forward and generating important data readouts this year,” Marc Hertz, PhD, Chief Executive Officer of GRI Bio.

CEL-SCI Corporation Issues Letter to Shareholders

Retrieved on: 
Wednesday, March 6, 2024

CEL-SCI Corporation (NYSE American: CVM) today issued a letter to its shareholders.

Key Points: 
  • CEL-SCI Corporation (NYSE American: CVM) today issued a letter to its shareholders.
  • This letter will be sent to the Company’s shareholders along with the proxy to the upcoming annual meeting.
  • In October 2023, the new data were presented at the 2023 European Society for Medical Oncology (ESMO) Congress.
  • These features make it easy to write a label for Multikine, which is essential for drug approval.

CEL-SCI Corporation Reports First Quarter Fiscal 2024 Financial Results

Retrieved on: 
Thursday, February 15, 2024

CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended December 31, 2023, as well as key recent clinical and corporate developments.

Key Points: 
  • CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended December 31, 2023, as well as key recent clinical and corporate developments.
  • In October 2023, the new data were presented at the 2023 European Society for Medical Oncology (ESMO) Congress.
  • CEL-SCI plans to submit the target population data to the U.S. Food and Drug Administration (FDA) this quarter.
  • CEL-SCI raised $5 million in November 2023 and $7.75 million in February 2024, both through public offerings of common stock.

RTW Charitable Foundation Announces Six Research Grant Recipients

Retrieved on: 
Monday, February 12, 2024

RTW Charitable Foundation (“RTWCF”) announced today that it has awarded $900,000 in research grants to support six research studies.

Key Points: 
  • RTW Charitable Foundation (“RTWCF”) announced today that it has awarded $900,000 in research grants to support six research studies.
  • “Optimizing AAV-SPL gene therapy for sphingosine phosphate lyase insufficiency syndrome” (Julie Saba, University of California, San Francisco, San Francisco, CA).
  • “RTW Charitable Foundation is proud to provide financial and scientific support to these six incredible researchers and their respective studies.
  • In addition to delivering financial resources, RTWCF also provides grant recipients with hands-on scientific support, helping them improve or further develop their research and research tools and identify new therapeutic targets.

CEL-SCI Reports Fiscal 2023 Financial Results and Clinical & Corporate Developments

Retrieved on: 
Friday, December 22, 2023

CEL-SCI Corporation (NYSE American: CVM) reported financial results for the fiscal year ended September 30, 2023, as well as key clinical and corporate developments.

Key Points: 
  • CEL-SCI Corporation (NYSE American: CVM) reported financial results for the fiscal year ended September 30, 2023, as well as key clinical and corporate developments.
  • CEL-SCI identified the target head and neck cancer patient population for Multikine that will be the basis for the Company’s regulatory filings for marketing clearance.
  • General and administrative expenses in fiscal 2023 were $9 million, a decrease of approximately $1.7 million, or 16%, compared to the year ended September 30, 2022.
  • Net loss narrowed by $4.5 million, or 12%, to approximately $32.2 million for the twelve months ended September 30, 2023 from $36.7 million in fiscal 2022.

Compass Pathways initiates UK component of global phase 3 study of psilocybin treatment in treatment-resistant depression and launches new research center

Retrieved on: 
Wednesday, November 15, 2023

The ongoing phase 3 program is the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted and follows promising results from Compass’s phase 2b study of COMP360 psilocybin treatment.

Key Points: 
  • The ongoing phase 3 program is the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted and follows promising results from Compass’s phase 2b study of COMP360 psilocybin treatment.
  • The phase 3 program consists of two pivotal trials (COMP 005 and COMP 006), and each trial has an integrated, long-term outcomes component.
  • COMP 006 will take place in the UK and globally and will study three dose arms of COMP360 (25mg, 10mg and 1mg).
  • COMP 005 is a US-based trial examining the effect of a single 25mg dose of COMP360 psilocybin, compared with placebo.

UK’S National Institute for Health and Care Excellence (NICE) Selects CEL-SCI’s Multikine as Potential New Standard of Care for Head & Neck Cancer

Retrieved on: 
Monday, December 4, 2023

NICE posted a detailed report from the UK’s National Institute for Health and Care Research (NIHR) regarding Multikine, its clinical data, and its potential to become a better standard of care in treating newly diagnosed head and neck cancer in the UK.

Key Points: 
  • NICE posted a detailed report from the UK’s National Institute for Health and Care Research (NIHR) regarding Multikine, its clinical data, and its potential to become a better standard of care in treating newly diagnosed head and neck cancer in the UK.
  • This published report informs UK doctors, patients, and other interested parties that NICE has started the review of Multikine and is soliciting public comment.
  • The NICE briefing includes the following statements:
    “The current standard of care for locally advanced SCCHN is an aggressive combined modality therapy.
  • According to Cancer Research UK , an average of 12,400 cases of head and neck cancer are diagnosed each year in the UK.

Eko Health Announces Large-Scale Deployment of AI Heart Disease Detection Technology

Retrieved on: 
Monday, November 6, 2023

EMERYVILLE, Calif. , Nov. 6, 2023 /PRNewswire/ -- Eko Health, Inc. (Eko), a leader in AI technology for heart and lung disease detection, today announced the regulatory approval (UKCA marking) and frontline deployment of the company's AI-enabled technology in the United Kingdom (UK). TRICORDER, a National Institute for Health and Care Research (NIHR) funded implementation program led by researchers at Imperial College London, will deploy Eko's AI-enabled technology (marketed in the U.S. as SENSORA™) to primary care practices across the UK. This novel implementation will assist clinicians in their evaluation of heart failure (HF), valvular heart disease (VHD), and atrial fibrillation (AFib), ultimately serving as an AI-enabled clinical decision support tool for echocardiogram referrals.   

Key Points: 
  • Imperial College London and UK NHS initiates TRICORDER program in primary care across the United Kingdom, targeting Heart Failure, Valvular Heart Disease, and Atrial Fibrillation
    EMERYVILLE, Calif. , Nov. 6, 2023 /PRNewswire/ -- Eko Health, Inc. (Eko), a leader in AI technology for heart and lung disease detection, today announced the regulatory approval (UKCA marking) and frontline deployment of the company's AI-enabled technology in the United Kingdom (UK).
  • Eko Health's AI-enabled technology has received UKCA markings and is being deployed in 100 UK primary care practices.
  • This novel deployment can potentially improve heart disease outcomes for millions of people in communities across the UK.
  • "This deployment around the UK of our AI-enabled heart disease detection technology demonstrates the need for accurate and early heart disease detection," said Connor Landgraf, Co-founder and CEO of Eko Health.

GRI Bio Announces Partnership with the Respiratory Translational Research Collaboration to Advance Leading NKT Regulation Technology Targeting Earlier in the Inflammatory Cascade to Modulate Disease Progression

Retrieved on: 
Tuesday, October 17, 2023

LA JOLLA, CA, Oct. 17, 2023 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced it has entered into a collaboration with the UK consortia, National Institute for Health and Care Research Respiratory Translational Research Collaboration (“NIHR Respiratory TRC”) to advance its leading NKT regulation technology to treat inflammatory, fibrotic and autoimmune diseases.

Key Points: 
  • Together with the NIHR Respiratory TRC, GRI Bio will design and execute complex multi-center studies that accelerate research for the benefit of respiratory disease patients.
  • “As a Company, we are dedicated to revolutionizing the way that inflammatory, fibrotic and autoimmune diseases like IPF are treated.
  • The establishment of this collaboration represents another important step forward as we work to advance our clinical development programs.
  • The NIHR Respiratory TRC offers cutting-edge translational research that we believe will assist in executing clinical studies underpinned by excellent scientific rigor.

Brainomix Partners with TIPAL Trial to Assess Its Novel IPF Biomarker in Lung Disease

Retrieved on: 
Friday, September 8, 2023

OXFORD, England, Sept. 8, 2023 /PRNewswire/ -- Brainomix announced today that they will be partnering with the TIPAL trial group to run a sub-study to assess the efficacy of its groundbreaking e-Lung platform. The TIPAL trial, funded by the National Institute of Health Research (NIHR) and sponsored by the Norfolk and Norwich University Hospitals (NNUH) NHS Foundation Trust, is a placebo-controlled 52-week multi-centre study that is evaluating the impact of lansoprazole – a commonly prescribed medication for indigestion, heartburn and acid reflux – on patients with a confirmed diagnosis of Idiopathic Pulmonary Fibrosis (IPF). IPF is a condition marked by relentless decline in lung function, but with a variable disease trajectory.

Key Points: 
  • OXFORD, England, Sept. 8, 2023 /PRNewswire/ -- Brainomix announced today that they will be partnering with the TIPAL trial group to run a sub-study to assess the efficacy of its groundbreaking e-Lung platform.
  • IPF is a condition marked by relentless decline in lung function, but with a variable disease trajectory.
  • The 298 patients expected to be enrolled in the trial will perform home spirometry tests to measure their forced vital capacity (FVC).
  • Professor Andrew Wilson, TIPAL Chief Investigator, said "It is great to have the chance to incorporate the cutting-edge CT scanning technology developed by Brainomix into the TIPAL study.