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Clinical Trial News

Edwards Lifesciences' SAPIEN 3 RESILIA Valve Shows Strong One-Year Outcomes in TAVI Trial

  • Edwards Lifesciences reports that patients treated with the SAPIEN 3 RESILIA valve experienced outstanding one-year outcomes, including lower mortality rates.
  • The PARTNER II trial, involving over 9,000 patients, demonstrated low reintervention rates and larger effective orifice areas with the SAPIEN 3 Ultra RESILIA valve.
  • The study found no paravalvular leak in 84.4% of cases using the SAPIEN 3 Ultra RESILIA valve, indicating improved valve performance and patient outcomes.
  • These real-world data reinforce the benefits of the SAPIEN valve platform, particularly in low surgical risk patients with longer life expectancies.

RHEIA (Randomized researcH in womEn All Comers With Aortic Stenosis)

NCT04160130Active, Not RecruitingNot Applicable
Optimapharm
Posted 11/29/2019

PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk

NCT01314313CompletedNot Applicable
Edwards Lifesciences
Posted 3/1/2011

Truqap Plus Abiraterone Shows Promise in PTEN-Deficient Metastatic Prostate Cancer

  • AstraZeneca's Truqap, combined with abiraterone and ADT, significantly improved radiographic progression-free survival in PTEN-deficient metastatic hormone-sensitive prostate cancer.
  • The Phase III CAPItello-281 trial demonstrated a clinically meaningful benefit compared to abiraterone and ADT with placebo in this specific patient population.
  • An early trend towards improved overall survival was observed, though data is still immature, with the trial continuing to assess this key secondary endpoint.
  • This combination marks the first AKT inhibitor to show benefit in this aggressive prostate cancer subtype, addressing a critical unmet need.

Scemblix Demonstrates Superior Efficacy Over TKIs in First-Line CML Treatment: 96-Week ASC4FIRST Trial Results

  • Scemblix (asciminib) shows significantly higher major molecular response (MMR) rate compared to investigator-selected tyrosine kinase inhibitors (TKIs) at 96 weeks in newly diagnosed chronic myeloid leukemia (CML) patients.
  • The ASC4FIRST trial demonstrates a favorable safety profile for Scemblix, with fewer discontinuations due to adverse events compared to TKIs.
  • These findings support Scemblix as a potential first-line treatment option for CML, offering improved efficacy and tolerability.
  • The 96-week data reinforce the potential of Scemblix to change the treatment paradigm for CML patients requiring first-line therapy.

CAR-T Therapy Shows Promise in Autoimmune Diseases with Minimal Toxicities

• A phase 1/2 study of CD19 CAR-T therapy in autoimmune diseases, including lupus, myositis, and systemic sclerosis, demonstrates significant clinical responses. • The CASTLE study reports minimal toxicities, with low-grade cytokine release syndrome and no major hematotoxicities or neurotoxicity observed in patients. • Cabaletta Bio's CABA-201 shows potential for immunosuppressant-free clinical responses in refractory autoimmune diseases, with ongoing trials and planned FDA meetings. • Next-generation manufacturing processes for CAR-T therapies, like that used for CC-97540, offer faster production times and require fewer cells for infusion.

RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis

NCT06359041RecruitingPhase 1
Cabaletta Bio
Posted 12/17/2024

RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus

NCT06121297RecruitingPhase 1
Cabaletta Bio
Posted 2/16/2024

RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy

NCT06154252RecruitingPhase 1
Cabaletta Bio
Posted 12/20/2023

RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis

NCT06328777RecruitingPhase 1
Cabaletta Bio
Posted 7/2/2024

A Phase 1/2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in Subjects With Active, Pemphigus Vulgaris (RESET-PV)

NCT04422912RecruitingPhase 1
Cabaletta Bio
Posted 9/29/2020

Clearside Biomedical Highlights Suprachoroidal Delivery Tech at Global Medical Meetings

  • Clearside Biomedical showcased its suprachoroidal delivery technology and pipeline programs at medical meetings across Asia, Europe, and the United States.
  • The company's SCS Microinjector has been used in over 10,000 injections, establishing Clearside as a leader in suprachoroidal space drug delivery.
  • Presentations included ODYSSEY topline results, XIPERE real-world data, and posters on their suprachoroidal delivery platform at APVRS Congress.
  • Clearside's CLS-AX program for wet AMD is Phase 3 ready, with additional Phase 2b ODYSSEY trial data to be presented at upcoming meetings.

LifeSignals' UbiqVue 2A System Receives FDA Clearance for Continuous Wireless Patient Monitoring

  • LifeSignals' UbiqVue 2A system, featuring a wearable biosensor, has gained FDA 510(k) clearance for continuous remote patient monitoring in diverse settings.
  • The biosensor, worn on the chest, monitors 13 physiological parameters, including SpO2, ECG, respiration rate, and body temperature, transmitting data securely to a cloud-based system.
  • The UbiqVue system aims to replace manual spot-checking with continuous, near real-time monitoring, enhancing patient safety and streamlining healthcare professional workflows.
  • LifeSignals plans to expand the UbiqVue system with additional vital signs monitoring and AI capabilities through partnerships with OEMs and service providers.

FDA Approves StemCyte's REGENECYTE, a Cord Blood Stem Cell Therapy

  • The FDA has approved StemCyte's REGENECYTE, a hematopoietic progenitor cell therapy derived from umbilical cord blood, for certain hematopoietic system disorders.
  • REGENECYTE is indicated for unrelated donor hematopoietic progenitor cell transplantation in patients with inherited, acquired, or myeloablative treatment-related disorders.
  • Clinical trials demonstrated neutrophil recovery in 76-91% of patients by day 42 and platelet recovery in 45-72% of patients by day 100 post-treatment.
  • StemCyte aims to expand its cell therapy portfolio, exploring REGENECYTE's potential in aging-related diseases, chronic fatigue syndrome, and acute stroke.

HanAll, Daewoong, and NurrOn Announce Positive Phase 1 Results for Parkinson's Disease Therapy HL192 (ATH-399A)

  • HanAll Biopharma, Daewoong Pharmaceutical, and NurrOn Pharmaceuticals completed a Phase 1 study of HL192 (ATH-399A) for Parkinson's disease, meeting primary endpoints for safety and tolerability.
  • The Phase 1 trial included single ascending dose (SAD), multiple ascending dose (MAD), and food effect components in 76 healthy participants, including older adults.
  • HL192 (ATH-399A) demonstrated a favorable safety profile with no serious treatment-related adverse events and supported once-daily dosing, paving the way for further clinical trials.
  • The companies plan to initiate the next clinical trial in people with Parkinson's disease to further evaluate the safety and efficacy of HL192 (ATH-399A).

FDA Accepts Alnylam's Vutrisiran Application for ATTR Amyloidosis with Cardiomyopathy

• The FDA has accepted Alnylam's sNDA for vutrisiran to treat ATTR amyloidosis with cardiomyopathy, setting a PDUFA date of March 23, 2025. • The application is based on Phase 3 HELIOS-B trial results, which demonstrated favorable cardiovascular outcomes and improved survival in ATTR-CM patients. • If approved, vutrisiran would be the first treatment for both polyneuropathy and cardiomyopathy manifestations of ATTR amyloidosis in the U.S. • Vutrisiran's sNDA acceptance signifies a major advancement for Alnylam, potentially expanding the drug's market and solidifying its position in the ATTR space.

Capivasertib Plus Abiraterone Extends Radiographic Progression-Free Survival in PTEN-Deficient mHSPC

  • Capivasertib combined with abiraterone and ADT significantly improved radiographic progression-free survival (rPFS) in patients with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC).
  • The CAPItello-281 Phase III trial demonstrated an early trend toward overall survival improvement, though data were immature at the time of analysis.
  • The safety profile of the capivasertib combination was consistent with the known profiles of each agent, according to AstraZeneca.
  • This combination marks the first AKT inhibitor to show benefit in this specific prostate cancer subtype, addressing a critical unmet need.

Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency

NCT04493853Active, Not RecruitingPhase 3
AstraZeneca
Posted 7/13/2020

Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration Resistant Prostate Cancer (mCRPC)

NCT05348577Active, Not RecruitingPhase 3
AstraZeneca
Posted 3/25/2022

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