Clinical Trial News

Jacobio Pharma announced Nature Medicine publication of glecirasib's pivotal phase II trial data for KRAS G12C mutant NSCLC, showing 47.9% response rate, 8.2 months median progression-free survival, and 13.6 months median overall survival. Glecirasib has a manageable safety profile and is under NMPA China's Priority Review.

A monoclonal antibody, CIS43LS, was found up to 88.2% effective in preventing malaria in African adults during a six-month malaria season, offering a new tool for malaria prevention in endemic regions. The NIH-sponsored trial highlights the potential for monoclonal antibodies to complement existing malaria interventions.

Switching to the AHCL system significantly improved glycemic control in 50 children and adolescents with type 1 diabetes, increasing time spent in the 70–140 mg/dL range and decreasing mean glucose concentration, especially at night, without increasing hypoglycemia or insulin doses.

A study by Invitae reveals genetic testing in epilepsy patients leads to clinical management changes in half, improving outcomes in 75%. It supports universal genetic testing for epilepsy to enhance care and outcomes, emphasizing precision medicine's role in treatment.

Raspagliesi et al. advanced SDT in 2021 using MRI-guided techniques with FL and 5-ALA induced PPIX in a porcine model, showing clinical feasibility. SDT combines ultrasound with sonosensitizers like PPIX and FL for targeted tumor treatment. HIFU and EFT, including Optune, show promise in GBM treatment, with ongoing trials to optimize efficacy and safety.

A large clinical trial found ivermectin does not significantly improve recovery time for mild to moderate COVID-19 cases, with recovery times of 12 vs. 13 days. The study, involving 817 ivermectin and 774 placebo participants, concluded against its use for COVID-19 treatment. FDA warns against using ivermectin for unapproved purposes.

The alfapump, a device for treating recurrent or refractory ascites due to liver cirrhosis, met primary effectiveness endpoints with 100% median reduction in therapeutic paracentesis and 77% of patients achieving at least 50% reduction. Safety data aligned with expectations, supporting a planned FDA PMA application in H2 2023. Over 60,000 North American patients could benefit, with numbers expected to grow.

The article reports on the first-in-human phase I trial, BrainChild-03, using B7-H3-specific CAR T cells for treating recurrent/refractory CNS tumors and DIPG in children. It highlights preclinical efficacy, clinical tolerability, and evidence of local immune activation and persistent CAR T cells in the CSF. The study suggests the feasibility of repeated intracranial B7-H3 CAR T-cell dosing, with one patient showing sustained improvement over 12 months.

The OlympiA phase III trial demonstrates a statistically significant improvement in overall survival (OS) with adjuvant olaparib compared to placebo in patients with germline BRCA1/2 pathogenic variants and high-risk, early breast cancer. With a median follow-up of 3.5 years, the trial shows a 3.4% absolute improvement in 4-year OS, alongside sustained improvements in invasive disease-free survival (IDFS) and distant disease-free survival (DDFS). The safety profile of olaparib remains favorable, with no new safety signals identified.

Reproxalap, a novel small molecule drug, inhibits RASP to reduce ocular inflammation in dry eye disease. Clinical trials show significant activity, with potential for early, broad efficacy and a unique product profile. Studied in over 1,800 patients, it's safe, with mild, transient discomfort reported. Aldeyra plans to advance 0.25% topical ocular reproxalap for treatment.