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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
Genprex Announces Positive Clinical Study Updates from Acclaim-1 and Acclaim-3 Phase 1/2 Clinical Trials in Lung Cancer
Genprex notes the patients in the Company's lung cancer clinical trials are being treated with the Company's lead drug candidate, Reqorsa® (quaratusugene ozeplasmid) Gene Therapy. Two patients in the Acclaim-1 study have had prolonged Progression Free Survival (PFS) and importantly, the first treated patient in the Acclaim-3 study attained a Partial Remission (PR) from the start of maintenance therapy.
Aethlon Medical Receives Second Ethics Committee Approval for Hemopurifier Cancer Trial
The Hemopurifier Cancer Trial will be conducted by Dr. Marco Matos and his staff at the Pindara Private Hospital, located in Queensland, Australia.
New Studies Validate the Value of Brainomix AI Technology Across US Stroke Networks
The latest research, in collaboration with the Mayo Clinic, West Virginia University, and Boston Medical Center, highlighted some of the cutting-edge, AI-enabled technology that the Oxford-based company has developed within its pipeline for the Brainomix 360 Stroke platform, representing groundbreaking capabilities that will enable physicians to extract maximal value from universally available non-contrast CT scans across stroke networks.
Teva Pharmaceuticals and Sanofi Announce Accelerated Timeline for Anti-TL1A Phase 2b Program in Patients with Inflammatory Bowel Disease
Patient enrollment in the RELIEVE UCCD (ulcerative colitis and Crohn’s disease) Phase 2b trial has completed early due to significant acceleration in patient recruitment. As a result, Teva Pharmaceuticals and Sanofi now anticipate having topline results for both UC and CD in Q4 2024, and detailed results will be presented in a scientific forum in 2025. This adjustment replaces the previously planned interim analysis for the second half of 2024, which will not be conducted. Teva and Sanofi are collaborating to co-develop and co-commercialize duvakitug for moderate-to-severe UC and CD patients.
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.