Clinical Trial News
Alder BioPharmaceuticals to Showcase Eptinezumab's Efficacy in Migraine Prevention at AHS Meeting
Alder BioPharmaceuticals announced the presentation of new data from the PROMISE 1 and PROMISE 2 phase 3 clinical trials for eptinezumab, their lead investigational product for migraine prevention, at the American Headache Society annual meeting. The data highlights eptinezumab's efficacy in reducing migraine days and improving quality of life for patients.
Sanofi Establishes €66 Million Global R&D Hub in Chengdu, Expanding China Research Footprint
- Sanofi is investing €66 million to establish a new global research hub in Chengdu, China, focusing on data analysis and management of multi-center clinical trials.
- The facility aims to recruit 300 R&D staff by 2020 and will support research across multiple therapeutic areas including diabetes, cardiovascular diseases, oncology, and rare diseases.
- This expansion establishes China as Sanofi's third major research pillar alongside France and the US, building upon their existing R&D presence in Shanghai.
Genetic Variants and Their Impact on Clinical Responses to Treatments
Recent studies have explored the relationship between genetic variants and clinical responses to various treatments, including mesalamine for ulcerative colitis, ALK inhibitors for non-small cell lung cancer, and metformin for type 2 diabetes. Findings suggest that while some genetic variants do not significantly affect treatment outcomes, others may influence drug efficacy and patient survival.
Vedolizumab: A New Therapeutic Option for Inflammatory Bowel Disease
Vedolizumab, a fully humanised monoclonal antibody, has emerged as a promising treatment for patients with moderate-to-severe ulcerative colitis and Crohn’s disease who are refractory or intolerant to conventional treatments or anti-TNFα agents. This article reviews the efficacy, safety, and tolerability of vedolizumab, highlighting its role in the treatment algorithms for inflammatory bowel disease based on clinical trials and real-world studies.
Pfizer, Amgen, and Sanofi Partner to Leverage Blockchain Technology in Clinical Trials
- Three pharmaceutical giants - Pfizer, Amgen, and Sanofi - have joined forces to explore blockchain technology's potential in enhancing data management and reducing drug development costs in clinical trials.
- Blockchain technology offers a secure, immutable platform for storing clinical trial data, addressing critical challenges in patient privacy, data integrity, and efficient information sharing across multiple databases.
- Research indicates only 16% of patients are aware of relevant clinical trials, highlighting the potential for blockchain to revolutionize patient recruitment and trial participation through anonymous data sharing and smart contracts.
Rising Demand for Comparator Clinical Trials Reshapes Drug Development Landscape
- Comparator clinical trials are experiencing increased demand driven by market competition, regulatory pressure, and the growing complexity of therapeutic protocols.
- Supply chain challenges in comparator studies, including product sourcing and logistics, significantly impact trial timelines and require careful planning and risk management.
- The shift towards comparator trials over placebo-controlled studies is motivated by ethical considerations and regulatory preferences, particularly in evaluating new drugs against existing treatments.
Landmark TAILORx Trial Shows 70% of Early-Stage Breast Cancer Patients Can Safely Skip Chemotherapy
- The TAILORx trial, involving over 10,000 women, demonstrates that approximately 70% of patients with hormone-receptor positive, HER2-negative early breast cancer can safely avoid chemotherapy when guided by genetic testing.
- Women over 50 with Oncotype DX recurrence scores of 0-25 showed no significant survival benefit from adding chemotherapy to hormone therapy alone.
- The findings could spare an estimated 65,000 women annually in the US from chemotherapy's toxic side effects while maintaining excellent long-term outcomes.
- This precision medicine approach represents the largest breast cancer trial to date and marks a paradigm shift toward personalized treatment strategies.
GSK Partners with Cloud Pharmaceuticals to Accelerate Drug Discovery Through AI Technology
- GlaxoSmithKline has entered a strategic collaboration with Cloud Pharmaceuticals to leverage AI-driven technology for designing novel small-molecule agents, marking Cloud's first major pharma partnership.
- Cloud Pharmaceuticals' proprietary AI platform claims to reduce traditional drug discovery timelines from over five years to just a few months, offering significant efficiency gains in lead molecule identification.
- The partnership follows GSK's $33 million deal with ExScientia and represents the company's first major AI initiative under Chief Digital Officer Karenann Terrell's leadership.
CRISPR Gene Editing Restores Dystrophin Expression in Canine DMD Model
- Systemic delivery of CRISPR gene editing components restored dystrophin expression in skeletal muscle of DMD dogs, ranging from 3 to 90% of normal levels.
- Cardiac muscle dystrophin levels reached 92% of normal in the dog receiving the highest dose, demonstrating significant cardiac muscle restoration.
- Treated dogs exhibited improved muscle histology, indicating a potential therapeutic benefit of gene editing for Duchenne muscular dystrophy.
- This large-animal study supports the clinical potential of gene editing approaches for treating DMD, warranting further development and clinical translation.
NeuClone Announces Positive Preclinical Results for Stelara® Biosimilar Candidate
- NeuClone's biosimilar candidate for Stelara® (ustekinumab) shows comparable 3D structure to the reference product through X-ray crystallography.
- The structural confirmation supports NeuClone's 'Right from the Start®' approach, ensuring high similarity to the original biologic from early development stages.
- Clinical trials for the Stelara® biosimilar, developed in partnership with Serum Institute of India, are planned to begin in 2019.
- Stelara®, a monoclonal antibody targeting IL-12 and IL-23, had global sales of $4.0 billion in 2017 and is used to treat conditions like plaque psoriasis and Crohn's disease.