UNIVERSITY OF CALIFORNIA, IRVINE
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Private, Subsidiary
- Established
- 1965-01-01
- Employees
- 10K
- Market Cap
- -
- Website
- http://www.uci.edu
Engineered Microglia: A Revolutionary Approach to Treating Alzheimer's Disease
• UC Irvine researchers have developed a groundbreaking therapy using CRISPR-edited microglia that can detect and target amyloid plaques in Alzheimer's disease, delivering therapeutic proteins precisely where needed.
• The engineered immune cells produce neprilysin, an enzyme that breaks down toxic beta-amyloid plaques, resulting in reduced inflammation, preserved neurons, and reversed neurodegeneration in mouse models.
• This novel approach overcomes the blood-brain barrier challenge by creating "living delivery systems" that reside in the brain itself, with potential applications for other neurological conditions including brain cancer and multiple sclerosis.
INSPIRE Trials: Computerized Alerts Improve Antibiotic Selection in Hospitalized Patients by Up to 35%
• NIH-funded clinical trials involving over 316,000 patients across 92 hospitals demonstrate that computerized alerts can improve appropriate antibiotic selection by 35% for abdominal infections and 28% for skin and soft tissue infections.
• The INSPIRE trials used patient-specific data to identify individuals at low risk for antibiotic-resistant infections, prompting physicians to switch from broad-spectrum to standard antibiotics when appropriate.
• Researchers from UC Irvine, Harvard Pilgrim Health Care Institute, and HCA Healthcare collaborated on the studies, which could significantly reduce antibiotic resistance and improve patient outcomes nationwide.
DeepQure's Novel Extravascular RDN Device Shows Promise in Global Hypertension Trials
• DeepQure's innovative HyperQure™ device demonstrates successful blood pressure reduction in initial trials across South Korea and the United States, with no reported complications.
• The company is expanding clinical trials to six leading U.S. universities, including Mayo Clinic and Stanford, aiming to enroll 15 patients in H1 2025 before initiating a pivotal study.
• DeepQure is broadening its technology application to treat atrial fibrillation, potentially offering an improved solution to reduce the 30-50% recurrence rates seen with current PVI treatments.
Narsoplimab Shows Promising Real-World Outcomes in TA-TMA Patients at 2025 Tandem Meetings
• Omeros Corporation will present real-world data from 128 transplant patients treated with narsoplimab for TA-TMA under an expanded access program at the 2025 Tandem Meetings in Honolulu.
• Key findings include outcomes from patients who received narsoplimab after failing eculizumab treatment, highlighting potential new treatment options for refractory cases.
• The investigational antibody, which targets MASP-2, maintains critical immune functions while awaiting FDA approval, with breakthrough therapy and orphan drug designations already secured.
DeepCure Completes First Patient Surgery in U.S. Clinical Trial for HyperCure, a Laparoscopic Renal Nerve Block Device
DeepCure has successfully completed the first patient surgery of HyperCure, the world's first laparoscopic renal nerve block (RDN) device, in a U.S. clinical trial. This milestone was achieved using a single-hole robot, marking a significant advancement in the treatment of resistant hypertension. The company aims to apply for a U.S. licensed clinical study by the end of the year, following the completion of patient enrollment and IRB approval.
BlueRock Therapeutics' Bemdaneprocel Advances to Phase 3 for Parkinson's Disease
• BlueRock Therapeutics is initiating a Phase 3 trial, exPDite-2, for bemdaneprocel, a cell therapy for Parkinson's disease, expected to begin in the first half of 2025.
• The exPDite-2 trial will enroll 102 patients with moderate Parkinson's, assessing the change in 'on' time without dyskinesia over 78 weeks compared to a sham surgery.
• Bemdaneprocel aims to replace dopamine-producing neurons lost in Parkinson's, with Phase 1 data showing tolerability and encouraging trends in motor function.
• The FDA granted bemdaneprocel Regenerative Medicine Advanced Therapy (RMAT) designation, potentially accelerating its development and review process.
Focused Ultrasound Shows Promise in Alzheimer's Treatment
• A clinical trial using focused ultrasound to treat Alzheimer’s disease has shown promising results, marking a potential new direction in treating this debilitating condition.
• The study, published in the Journal of Neurosurgery, highlights the noninvasive nature of focused ultrasound as a key advantage in Alzheimer's treatment.
• Researchers are optimistic about the potential of this approach to offer a new therapeutic avenue for patients suffering from Alzheimer's disease.
• Further research is needed to fully understand the long-term effects and optimal use of focused ultrasound in Alzheimer's treatment.
Bayer's Cell and Gene Therapy Programs for Parkinson's Disease Enter Clinical Trials
• Bayer's BlueRock Therapeutics initiated a Phase 1 trial of DA01, a cell-based therapy using stem cell-derived dopaminergic neurons, to replenish lost neurons in Parkinson's patients.
• AskBio, another Bayer subsidiary, has begun a Phase 1b trial of its gene therapy for Parkinson's, aiming to halt or reverse motor control decline by delivering a gene for glial cell line-derived neurotrophic factor (GDNF).
• The FDA granted fast-track review to BlueRock's DA01, potentially accelerating its development through increased communication with the regulator and a shorter review period.
• These trials mark a significant step in Bayer's strategy to develop cell and gene therapies that could regenerate dopamine-producing neurons, addressing a major unmet need in Parkinson's disease.
Regenxbio Expands MPS I Gene Therapy Trial After Initial Data Review
Regenxbio has decided to expand its phase 1/2 trial for RGX-111, a gene therapy targeting mucopolysaccharidosis type I (MPS I), following promising initial data showing clinical activity. The therapy aims to deliver a functional copy of the IDUA gene to the central nervous system, offering a potential one-shot treatment for this rare inherited disease.
AccurKardia's AI-Powered Hyperkalemia Detection Software Receives FDA Breakthrough Device Designation
• AccurKardia's AK+ Guard, an AI-powered software, has received FDA Breakthrough Device Designation for hyperkalemia detection using Lead I ECG data.
• AK+ Guard aims to detect moderate to severe hyperkalemia episodes, potentially preventing sudden cardiac arrest through early alerts.
• Designed for use with various FDA-cleared wearables, AK+ Guard enables hyperkalemia monitoring outside clinical settings, benefiting high-risk populations.
• The technology has also been accepted into the FDA's Total Product Life Cycle Advisory Program (TAP) to expedite regulatory processes.
FDA Panel Urges Caution and More Data on RSV Vaccine Safety in Infants
• An FDA advisory panel called for more safety data on RSV vaccines for infants, highlighting concerns after a partial pause in clinical trials.
• The pause was triggered by cases of severe RSV in infants receiving Moderna's experimental vaccines, raising questions about vaccine-associated enhanced respiratory disease (VAERD).
• The panel emphasized the need for a better understanding of immune responses in different age groups and continued monitoring of trial participants.
• Despite concerns, advisors spoke positively about Sanofi's Beyfortus and Pfizer's maternal RSV vaccine, and did not call for halting all infant RSV vaccine studies.
Metabolomics Predicts Platinum Resistance in Gynecologic Cancers
• A metabolomics study shows potential in predicting platinum resistance in gynecologic cancers, offering insights into personalized treatment strategies.
• The study identified metabolic signatures correlating with cisplatin sensitivity, potentially guiding treatment decisions for ovarian and uterine cancer patients.
• Researchers emphasize the need for cost-effective, minimally invasive screening methods, suggesting metabolomics could fill gaps in healthcare disparities.
• Further validation across diverse cancer types is necessary to refine the clinical utility of metabolomic signatures in predicting treatment outcomes.
FDA Clears AI Tool AutoChamber for Detecting Heart Disease Risk on Chest CT Scans
• The FDA has cleared HeartLung Technologies' AutoChamber, an AI tool that identifies cardiovascular risk factors from standard chest CT scans, including those performed for lung cancer screening.
• AutoChamber analyzes CT scans to evaluate the risk of heart failure, atrial fibrillation, and stroke, conditions often unreported in current CT scan analyses.
• The AI tool received FDA's breakthrough device designation, expediting its approval process due to its potential to improve patient outcomes through earlier intervention.
• Experts suggest AutoChamber could significantly enhance cardiovascular risk assessment for millions undergoing chest CT scans, leading to timely interventions.
HeartLung Technologies' AutoChamber AI Receives FDA Breakthrough Device Designation for Cardiac Chamber Volumetry
• HeartLung Technologies' AutoChamber AI, designed for cardiac chamber volumetry, has received FDA Breakthrough Device designation and marketing authorization.
• AutoChamber AI analyzes non-contrast CT scans to report cardiac chamber volumes and left ventricular wall mass, aiding in early detection of heart failure, atrial fibrillation, and stroke.
• Studies presented to the FDA demonstrated AutoChamber AI's superior performance compared to traditional risk scores in predicting cardiovascular events.
• The AI tool integrates into existing CT scan workflows, offering a cost-effective solution for identifying high-risk patients and enabling earlier interventions.
HeartLung Technologies' AutoChamber AI Receives FDA Breakthrough Status for Opportunistic Heart Disease Detection
• HeartLung Technologies' AutoChamber AI received FDA Breakthrough Device designation and marketing authorization for opportunistic heart disease detection in CT scans.
• AutoChamber AI analyzes thoracic CT scans to evaluate the risk of heart failure, atrial fibrillation, and stroke, conditions often missed in current radiology reports.
• The AI leverages deep learning to analyze cardiac chamber volumes, providing a quantitative imaging report within seconds to aid physicians in early intervention.
• Studies presented to the FDA demonstrated AutoChamber AI's superior performance compared to traditional risk scores in predicting heart failure, atrial fibrillation and stroke.
Neuvivo Submits NDA to FDA for NP001, a Potential Breakthrough ALS Treatment
• Neuvivo has submitted a New Drug Application (NDA) to the FDA for NP001 (sodium chlorite infusion) for treating amyotrophic lateral sclerosis (ALS).
• NP001 is a novel investigational immunotherapy designed to restore balance within the innate immune system, potentially slowing ALS progression.
• If approved, NP001 could be the first disease-modifying therapy for ALS that preserves lung function and extends overall survival by up to a year.
• The FDA has granted NP001 Orphan Drug and Fast Track Designations, making it eligible for Accelerated Approval and Priority Review.
Neuvivo Seeks FDA Approval for NP001, a Novel Immunotherapy for ALS
• Neuvivo has submitted a New Drug Application (NDA) to the FDA for NP001, an investigational treatment for amyotrophic lateral sclerosis (ALS).
• NP001 is designed to restore balance to the innate immune system, potentially modifying the course of ALS by addressing uncontrolled inflammation.
• Clinical data suggest NP001 may preserve lung function and extend overall survival, particularly in patients with specific biomarkers indicating inflammation.
• The FDA has granted NP001 Orphan Drug and Fast Track designations, potentially expediting the review and approval process.
Bayer's Bemdaneprocel Shows Positive 24-Month Data in Parkinson's Disease Trial
• Bayer and BlueRock Therapeutics' bemdaneprocel, a cell therapy for Parkinson's, shows a favorable safety profile in a Phase 1 trial.
• The exPDite trial's 24-month data indicates transplanted cells survive and engraft in the brain after immunosuppression ends.
• High-dose cohort shows a 21.9-point mean reduction in motor symptoms, assessed by MDS-UPDRS Part III, compared to baseline.
• Bemdaneprocel receives FDA's RMAT designation, potentially expediting its development and review process for Parkinson's treatment.
BlueRock Therapeutics' Bemdaneprocel Receives FDA RMAT Designation for Parkinson's Disease
• BlueRock Therapeutics' bemdaneprocel, a cell therapy for Parkinson's disease, has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA.
• The RMAT designation allows for expedited development review and planning guidance from the FDA, potentially accelerating the path to approval.
• Phase I trial data showed bemdaneprocel was well-tolerated with no major safety issues after 18 months, and demonstrated cell survival in the brain.
• Bemdaneprocel aims to replace dopamine-producing neurons lost in Parkinson's, offering a potential disease-modifying treatment option.
BlueRock Therapeutics' Bemdaneprocel Shows Promise in Parkinson's Disease Phase I Trial
• BlueRock Therapeutics' bemdaneprocel demonstrates sustained cell survival and increasing F-DOPA signal after immunosuppression cessation in Parkinson's patients.
• High-dose cohort shows significant motor symptom improvement, with a 2.7-hour increase in 'Good ON' state and a 23-point reduction in MDS-UPDRS Part III score.
• The Phase I trial indicates potential for addressing non-motor symptoms, with neuropsychological evaluations suggesting improvements in memory and cognitive function.
• A Phase II trial is planned to commence later in 2024 to further evaluate bemdaneprocel's efficacy in treating Parkinson's disease.
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