Clinical Trial News
Study Protocol of the LAUNCH 3 Trial: Comparing Laparoscopic and Abdominal Radical Hysterectomy for Cervical Cancer
The LAUNCH 3 trial is a prospective, randomized, open, blinded endpoint (PROBE) controlled trial designed to compare the efficacy of laparoscopic radical hysterectomy (LRH) versus abdominal radical hysterectomy (ARH) in patients with stages IB3 and IIA2 cervical cancer. The study aims to enroll 1104 patients over 3 years, with a follow-up period of at least 5 years to assess overall survival, progression-free survival, recurrence, and quality of life.
Highlighted Clinical Trials:
Obstetrics & Gynecology Hospital of Fudan University
Posted 5/12/2021
Yale Researchers Develop Polymer Nanoparticles for Effective mRNA Delivery to Lungs
- Researchers at Yale University have developed biodegradable polymer nanoparticles that can effectively deliver mRNA to lung cells, achieving high transfection rates in epithelial and antigen-presenting cells.
- The optimized poly(amine-co-ester) (PACE) polymer formulation protects mRNA from degradation and demonstrates better biocompatibility than existing delivery methods, with potential applications for respiratory diseases.
- When tested as a mucosal vaccine against SARS-CoV-2, the intranasal PACE-mRNA system induced robust immune responses and protected mice from lethal viral challenge, highlighting its potential for respiratory vaccines and therapies.
Phase 3 CLEAR Study Shows Improved Efficacy of Lenvatinib Plus Pembrolizumab in Advanced Renal Cell Carcinoma
The phase 3 CLEAR study demonstrates that lenvatinib combined with pembrolizumab significantly improves efficacy outcomes over sunitinib in patients with advanced renal cell carcinoma (RCC), regardless of baseline prognostic features such as metastases location, prior nephrectomy, and sarcomatoid histology.
Highlighted Clinical Trials:
Eisai Inc.
Posted 10/13/2016
Nexcella's NXC-201 Shows Promise in Relapsed/Refractory Multiple Myeloma and AL Amyloidosis
- Nexcella's NXC-201, a BCMA-targeted CAR-T therapy, demonstrates promising clinical data in relapsed/refractory multiple myeloma and AL amyloidosis.
- Updated clinical data on NXC-201 will be presented at the 20th International Myeloma Society Annual Meeting in Athens, Greece.
- The NEXICART-1 trial, a Phase 1b/2a study, evaluates the safety and efficacy of NXC-201 in adults with relapsed/refractory multiple myeloma and AL amyloidosis.
- Nexcella plans to submit data to the FDA for NXC-201 in relapsed/refractory multiple myeloma and AL amyloidosis after treating a target number of patients.
Highlighted Clinical Trials:
Immix Biopharma, Inc.
Posted 2/3/2023
Hadassah Medical Organization
Posted 1/1/2021
European Commission Approves Axicabtagene Ciloleucel for Second-Line DLBCL and HGBL
- Axicabtagene ciloleucel (axi-cel) has been approved by the European Commission for adult patients with relapsed or refractory DLBCL and HGBL after first-line chemoimmunotherapy.
- The approval is based on the ZUMA-7 trial, which demonstrated a significant improvement in event-free survival (EFS) with axi-cel compared to standard of care.
- Axi-cel showed an EFS of 8.3 months versus 2.0 months with standard of care, and a 2-year EFS rate of 41% versus 16%, respectively.
- The treatment also led to improvements in quality of life, marking a significant advancement in the treatment of LBCL after initial treatment failure.
Highlighted Clinical Trials:
Kite, A Gilead Company
Posted 1/25/2018
ACELYRIN's Izokibep Shows Promise in Hidradenitis Suppurativa and Psoriatic Arthritis Trials
- Early data from a Phase 2b/3 trial of izokibep in Hidradenitis Suppurativa (HS) shows improvement in draining tunnels in two-thirds of patients by week 4.
- Enrollment is complete for the Phase 2b/3 trial of izokibep in Psoriatic Arthritis (PsA), with top-line data expected in Q1 2024, accelerated from mid-2024.
- ACELYRIN possesses a strong cash position of $823.0 million, supporting the advancement of multiple late-stage clinical programs across its portfolio.
- A Phase 3 program is planned to evaluate izokibep for axial spondyloarthritis (AxSpA) in 2024, following positive enthesitis resolution data from a Phase 2 PsA trial.
Xeltis Secures €12.5 Million to Advance aXess Vascular Graft Development
- Xeltis has secured an additional €12.5 million from the European Innovation Council (EIC) Fund, bringing the total raised to €44.5 million, to support its cardiovascular implant developments.
- The funding will primarily support the first-in-human (FIH) trial of aXess vascular graft for chronic kidney disease patients needing hemodialysis and an ongoing pivotal trial across Europe.
- Xeltis' endogenous tissue restoration platform uses a polymer implant to regenerate the patient's own tissue, creating living and long-lasting vessels before being absorbed.
- Six-month data from the aXess-FIH study were presented at the Vascular Access Society Congress, highlighting the progress of the implantable blood vessel for hemodialysis vascular access.
Wegovy Reduces Cardiovascular Risk by 20% in Obese Patients with Heart Disease History
- Novo Nordisk's Wegovy demonstrated a 20% reduction in the risk of stroke, heart attack, and other cardiovascular events in overweight individuals with prior heart disease.
- The SELECT trial involved over 17,600 participants and compared Wegovy to a placebo, indicating potential for significant health benefits beyond cosmetic weight loss.
- Experts suggest the findings could shift perceptions and insurance coverage of weight-loss drugs, recognizing obesity as a serious illness contributing to cardiovascular problems.
- The company plans to seek regulatory approval to include cardiovascular benefits on Wegovy's label, potentially changing obesity treatment and healthcare costs.
ASCO Updates Guidelines: ESR1 Mutation Testing Recommended for Advanced Breast Cancer
- ASCO now recommends routine ESR1 mutation testing for HR-positive, HER2-negative advanced breast cancer upon disease recurrence or progression on endocrine therapy.
- The recommendation follows the EMERALD trial, which demonstrated improved progression-free survival with elacestrant in patients with ESR1 mutations.
- Testing can be performed on blood or tissue, ideally at the time of progression, with blood-based ctDNA testing preferred for its greater sensitivity.
- Alternative treatments, such as endocrine therapy combined with alpelisib or everolimus, are available for patients without ESR1 mutations.
First Veteran Receives FDA-Approved Qalsody for SOD1-ALS at Houston VA Medical Center
- Roy Swearingen, a 65-year-old Marine Corps veteran from Texas, became the first veteran in the United States to receive Qalsody, an FDA-approved medication for SOD1-mutated ALS.
- Qalsody represents the first approved treatment targeting a genetic cause of ALS, specifically for patients with mutations in the superoxide dismutase 1 (SOD1) gene, affecting 1-2% of ALS patients.
- The Houston VA ALS Center's rapid implementation of this cutting-edge therapy demonstrates the VA's commitment to providing veterans with timely access to innovative treatments.
- Veterans face higher ALS risk compared to the general population, making early detection and specialized care crucial for optimal quality of life management.