Clinical Trial News
FORE Biotherapeutics Highlights Recent Pipeline Achievements and Strategic Objectives for 2025
FORE Biotherapeutics, a biotherapeutics company focused on developing targeted cancer therapies, has outlined its recent pipeline achievements and key strategic objectives for 2025. The company's CEO, William Hinshaw, will present these developments at the 43rd Annual J.P. Morgan Healthcare Conference. Fore's focus includes the continued development of plixorafenib, a novel BRAF inhibitor, with potential to set new standards in treating BRAF-driven tumors. The company also reported significant progress in its FORTE Master Protocol trials, demonstrating promising safety and efficacy data across various tumor types.
Loyal Launches Clinical Study for LOY-002, Aiming to Extend Lifespan in Senior Dogs
• Loyal has initiated a clinical study named STAY to evaluate LOY-002, a drug designed to extend lifespan and enhance the quality of life for senior dogs.
• The STAY study plans to enroll 1,000 senior dogs across 70 veterinary clinics in the United States, encompassing dogs of nearly all sizes.
• LOY-002 represents a significant effort to address aging and improve healthspan in canines, potentially transforming veterinary care for older dogs.
FDA Grants Priority Review to Dizal's Sunvozertinib for EGFR Exon20 Insertion-Positive NSCLC
• The FDA has granted priority review to sunvozertinib for NSCLC with EGFR exon 20 insertion mutations after platinum-based chemotherapy.
• Sunvozertinib's NDA is based on the pivotal WU-KONG1 Part B study, which demonstrated statistically significant clinical benefits.
• If approved, sunvozertinib would be the first oral small molecule drug approved in the U.S. or Europe for this indication, offering a convenient and safe treatment option.
• Sunvozertinib has already received accelerated approval in China for the same indication based on the results of the WU-KONG6 study.
Loyal's Large-Scale Clinical Trial Aims to Extend Dog Lifespan
• Loyal is conducting a clinical trial to evaluate a daily chewable medication aimed at extending the lifespan and improving the quality of life for dogs aged 10 years and older, weighing at least 14 pounds.
• The trial spans up to four years, requiring owners to administer the medication daily and complete surveys on their dog's well-being, either at the vet clinic or remotely.
• Participating owners must commit to transferring their dog's primary care to the study clinic, involving six visits in the first year and two visits annually for the remaining duration of the study.
Lung Cancer Patients in England to Receive Breakthrough Drug Sotorasib on NHS
NHS lung cancer patients in England will soon have access to Sotorasib, a revolutionary drug targeting the KRAS G12C mutation, known as the 'Death Star' mutation, marking a significant breakthrough in cancer treatment. This drug, the first of its kind, has been proven in clinical trials to halt lung cancer growth for seven months and will be available to around 600 patients annually through an early-access agreement.
Probenecid, a Gout Medication, Shows Promise as Broad-Spectrum Antiviral Against COVID-19 and Other Respiratory Viruses
• A new study indicates that probenecid, an FDA-approved drug for gout, exhibits broad antiviral properties against SARS-CoV-2, RSV, and influenza viruses.
• Probenecid functions by blocking viral replication within cells, demonstrating effectiveness as both a prophylactic and post-exposure treatment in animal models.
• Current COVID-19 treatments like remdesivir and monoclonal antibodies are expensive and require IV administration, whereas probenecid is an accessible oral medication.
• Clinical trials are planned to determine optimal dosages, with potential for probenecid to enhance the efficacy of other antiviral treatments.
NHS Pioneers Early Access to Amgen's Breakthrough KRAS Lung Cancer Drug Lumykras
• The MHRA has approved Lumykras (sotorasib) for previously treated advanced NSCLC with KRAS G12C mutation, making Britain the first in Europe to offer this groundbreaking treatment.
• In clinical trials, Lumykras demonstrated significant efficacy with a 37.1% response rate and disease control in 80.6% of patients, marking a major advancement in targeting the previously "undruggable" KRAS mutation.
• The NHS will begin offering Lumykras to approximately 600 eligible lung cancer patients in England within weeks, through an early access agreement while NICE conducts cost-effectiveness evaluation.
Meta-Analysis Reveals Significant Efficacy Reporting Bias in CAR T-Cell Therapy Clinical Trials
• A comprehensive meta-analysis of CAR T-cell therapy trials reveals an 8-12% overestimation of efficacy when using modified intent-to-treat (mITT) versus intent-to-treat (ITT) populations, raising concerns about selection bias.
• For BCMA-targeted CAR T-cell therapy in multiple myeloma, the pooled overall response rate was 78% in mITT analyses compared to 70% in ITT analyses, with 46 enrolled patients never receiving the therapy.
• CD19-targeted CAR T-cell therapy studies showed similar discrepancies, with response rates of 79% for mITT versus 68.1% for ITT populations, highlighting the need for more transparent reporting in clinical trials.
Acupuncture Shows Promise in Alleviating Combat-Related PTSD Symptoms in Veterans
• A randomized, placebo-controlled trial is underway to evaluate the clinical and biological effects of verum acupuncture for combat-related PTSD in US Veterans.
• The study compares verum acupuncture to sham acupuncture, assessing changes in PTSD symptom severity and psychophysiological responses.
• Researchers aim to address limitations of previous acupuncture trials by including a sham control, biological outcomes, and monitoring protocol adherence.
• Expected results will offer definitive insights into acupuncture's efficacy, potentially influencing PTSD treatment approaches within and beyond the VA system.
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VA Office of Research and Development
Posted 4/5/2018
Blockchain Technology Poised to Transform Healthcare Data Management and Patient Privacy
• Current electronic health record (EHR) systems face significant challenges, contributing to physician burnout and inefficiencies in healthcare delivery while failing to meet privacy and accessibility expectations.
• Blockchain technology offers a revolutionary solution for medical records management, providing immutable, secure data storage while enabling real-time access and updates across healthcare networks.
• The proposed blockchain-based system would empower patients with unprecedented control over their medical data access, while ensuring healthcare providers have reliable, up-to-date information for treatment decisions.