Clinical Trial News

The ROP-ET trial evaluates ropeginterferon alfa-2b's efficacy and safety in ET patients intolerant or resistant to other treatments. It aims for durable blood count remission, symptom improvement, and assesses disease modification over 36 months. Patients receive subcutaneous injections, with dose adjustments based on response and tolerability.

Jacobio Pharma has received IND approval from the FDA for its self-developed drug JAB-30355, a P53 Y220C activator, marking a significant step towards initiating a Phase I/IIa clinical trial for advanced solid tumors in the US. The drug targets the P53 Y220C mutation, prevalent in approximately 50% of all invasive tumors, and has shown promising results in preclinical studies.

4SC AG filed a Marketing Authorisation Application with the EMA for resminostat (Kinselby) for CTCL treatment, following positive RESMAIN study results showing significant PFS improvement and manageable side effects. This marks a significant advancement in 4SC's efforts to commercialize resminostat and enhance patient care.

The FDA has granted accelerated approval to lifileucel, a tumour-derived autologous T cell immunotherapy, for treating adult patients with unresectable or metastatic melanoma who have been previously treated with specific therapies. The approval is based on a study showing an objective response rate of 31.5% among treated patients.

FIRE1 completed patient enrollment in the U.S. Early Feasibility Study for its FIRE1™ System, aimed at remote heart failure monitoring by measuring the inferior vena cava. The study involved 15 patients across five U.S. centers. The system seeks to improve heart failure management by enabling patients to monitor fluid volume at home, potentially reducing hospital admissions.

The FDA has approved Amtagvi, the first tumor-infiltrating lymphocyte (TIL) therapy, for patients with metastatic melanoma unresponsive to other treatments. This innovative therapy uses the patient's own immune cells to fight cancer, showing promising results in clinical trials.

A 16-week course of the monoclonal antibody omalizumab has shown to significantly increase the amount of peanut, tree nuts, egg, milk, and wheat that multi-food allergic children can consume without an allergic reaction, offering a new protective measure against accidental exposure.

IMUNON, Inc. announces Memorial Sloan Kettering Cancer Center's participation in a Phase 1/2 trial for IMNN-001 combined with bevacizumab in advanced ovarian cancer patients. The trial aims to assess minimal residual disease and progression-free survival, with initial results expected within a year. IMNN-001, a DNA-based IL-12 immunotherapy, shows promise in transforming ovarian cancer treatment.

The ARASENS trial highlights the efficacy of darolutamide combined with androgen-deprivation therapy and docetaxel, showing a significant reduction in the risk of death for patients with metastatic hormone-sensitive prostate cancer.

A groundbreaking study published in the New England Journal of Medicine reveals that CAR-T cell therapy can effectively treat severe autoimmune diseases by rebooting the immune system, eliminating the need for long-term immune-suppressive drugs.