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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
Trial Approval for New Pacemaker Aiming to Boost Recovery in Heart Failure
The system has shown a remarkable ability to boost performance and induce cardiac repair mechanisms in subjects with heart failure.
Enterprise Therapeutics Doses First Person with Cystic Fibrosis in Phase 2 Trial for Novel Therapy ETD001
Dr John Ford, CEO, Enterprise Therapeutics, said: “The dosing of the first person with CF in our Phase 2a trial of ETD001 represents an incredible milestone, testament to Enterprise’s dedication to advancing a novel approach to treating pwCF with the highest unmet medical need. ETD001 has already demonstrated an excellent safety profile in healthy participants, as well as a pharmacokinetic (PK) profile consistent with a long lung residency. We look forward to progressing ETD001 through Phase 2 trials and beyond.”
TCBP Announces Dosing of 6th Patient in ACHIEVE Study in Patients with Acute Myeloid Leukemia
The ACHIEVE Study UK clinical trial is an open-label, phase II study designed to evaluate the efficacy and effectiveness of TCB-008 in patients with AML or MDS/AML, with either refractory or relapsed disease. ACHIEVE is comprised of two cohorts representing separate disease states. The protocol allows for either cohort to be advanced as an independent Phase III Pivotal Trial upon completion of the cohort, presuming the primary efficacy endpoints is met.
Blood Filtration Offers Hope in the Fight Against Pancreatic Cancer
In a groundbreaking advancement of a novel cancer treatment, researchers have successfully deployed Seraph® 100 blood filtration media to demonstrate removal of Circulating Tumor Cells (CTCs) from the blood of patients suffering from advanced pancreatic cancer.
Mabwell Receives NMPA Approval for Clinical Trial of Novel Nectin-4 Targeting ADC in TNBC
The study includes two cohorts: Cohort A will enroll patients with locally advanced or metastatic TNBC who have previously received taxane/anthracycline-based chemotherapy and topoisomerase inhibitor based antibody-drug conjugate treatment, and will receive 9MW2821 monotherapy; Cohort B will enroll patients with locally advanced or metastatic TNBC who have not previously received systemic therapy, and will receive a combination treatment of 9MW2821 and a PD-1 inhibitor reports Mabwell.
Phage-Derived Enzyme Targets E. faecalis Biofilms to Mitigate Acute Graft-Versus-Host Disease
In a recent study published in the journal Nature, our researchers have identified a bacteriophage-derived enzyme called endolysin that targets Enterococcus faecalis biofilms. This discovery offers a promising new approach to mitigating acute graft-versus-host disease (aGVHD) in patients undergoing stem cell transplantation. The enzyme's ability to specifically target harmful bacteria without affecting beneficial ones could revolutionize treatments for aGVHD.
OSE Immunotherapeutics Announces Publication of Preclinical Efficacy Results with Lusvertikimab in Acute Lymphoblastic Leukemia in the Journal ‘Blood’
Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, concludes: “We are very pleased with this publication on Lusvertikimab in ‘Blood’, a high-level journal within the field of hematology whose manuscripts are reviewed by prominent specialists. Novel targeted immunotherapy options are urgently needed for B-ALL and T-ALL patients and we are happy to collaborate with the research leaders in hematology from the University of Kiel to face this clinical challenge.”
PharmaEssentia Completes Patient Enrollment for Phase 2b EXCEED-ET Trial in Essential Thrombocythemia and Phase 3b ECLIPSE-PV Trial in Polycythemia Vera
"Myeloproliferative neoplasms, including ET and PV, are chronic blood diseases that can impact patients' quality of life and lead to life-threatening complications, including the development of specific types of blood cancers, and PharmaEssentia is committed to developing new therapeutic solutions for these patients,” said Robert B. Geller, M.D., Head of Medical at PharmaEssentia USA. “We are thrilled with the pace at which we have enrolled patients, which we believe reflects a high level of interest in both the EXCEED-ET and ECLIPSE-PV trials. Our goal with each of these programs is to redefine the early treatment paradigm of myeloproliferative neoplasms.”
Dr Fred Cohen: Higher Temperatures Trigger Migraines According to New Study
In the study, researchers examined 71,030 daily diary records from 660 migraine patients and correlated them with regional weather data. They discovered that for each 10-degree Fahrenheit rise in daily temperature, there was a 6% increase in headache occurrences reports Dr Fred Cohen.