Clinical Trial News

SpecGx LLC received a Complete Response Letter from the FDA regarding its NDA for an abuse-deterrent, immediate-release reformulation of Roxicodone. The FDA requested further evaluation for potential approval. SpecGx plans to discuss the FDA's guidance and continues efforts to mitigate opioid abuse through technology and community programs.

Fox Chase Cancer Center's RETAIN Bladder study explores active surveillance over bladder removal for MIBC patients post-chemotherapy, using genetic mutations and clinical features to predict treatment success. Aiming to preserve quality of life, the study identifies patients who may avoid cystectomy, with ongoing research into biomarkers and treatment efficacy.

In the LYM-3002 study, VR-CAP showed significantly longer median overall survival (90.7 months) compared to R-CHOP (55.7 months) in untreated mantle cell lymphoma patients, with a manageable safety profile. Results support further VR-CAP assessment.

CRISPR gene editing in a DMD dog model restored dystrophin levels up to 90% in skeletal and 92% in cardiac muscles, improving muscle histology, indicating potential clinical utility for DMD treatment.

NeuClone announced positive preclinical results for its Stelara® biosimilar, confirming structural integrity via X-ray crystallography. Developed with Serum Institute of India, it's set for Phase I trials in 2019. Stelara®, a monoclonal antibody, treats diseases like plaque psoriasis and Crohn's disease. NeuClone focuses on biosimilar development using its NeuMAX® platform.

The ESPOUSE Study evaluated sTMS for migraine prevention, showing a significant reduction in headache days (−2.75 ± 0.40) and a 46% responder rate. Adverse events were minor, with no serious events reported. sTMS is effective and well-tolerated for migraine prevention.

Nivolumab and low-dose ipilimumab show durable clinical benefit for MSI-H/dMMR metastatic CRC patients, with 84% tumor burden reduction, 74% PFS, and 79% OS at 24 months. The combination, well-tolerated with a 69% response rate, may offer a new first-line therapy option.

Pipeline Watch provides a weekly overview of selected late-stage clinical trial updates from pharmaceutical and biotech companies, shared at conferences, in presentations, and through official releases.

Clinical trials often exclude patients with comorbidities, limiting access to investigational therapies. A study led by Dr. Montalban Bravo explored treating 'unfit' AML and MDS patients with azacitidine and vorinostat, showing feasibility and clinical benefit. Results suggest relaxing exclusion criteria could expand trial access and benefit patients with poor prognoses.

Landiolol, an ultra-short acting β1-blocker, effectively reduces heart rate in atrial fibrillation without significant blood pressure drop. It shows higher cardioselectivity and potency than esmolol, with similar pharmacokinetics in Caucasian and Asian populations. Clinical trials confirm its efficacy and safety in emergency settings.