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Clinical Trial News

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.

First Immunotherapy Success in Prostate Cancer Shows Promise for DNA Repair-Deficient Tumors

Precision Medicine
  • A landmark clinical trial demonstrates that pembrolizumab immunotherapy provides survival benefits for a subset of men with advanced, otherwise untreatable prostate cancer.
  • Of 258 men treated with pembrolizumab, 38% remained alive after one year and 11% continued treatment without disease progression.
  • Men with DNA repair gene mutations in their tumors showed higher response rates, suggesting genetic testing could identify optimal candidates for immunotherapy.
  • Researchers are planning a new trial specifically targeting prostate cancer patients with DNA repair mutations to validate this precision medicine approach.

Landmark TAILORx Trial Shows 70% of Early-Stage Breast Cancer Patients Can Safely Skip Chemotherapy

Precision MedicineOncology
• 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.

sTMS Shows Promise for Migraine Prevention in Open-Label Study

  • A multicenter, prospective, open-label study suggests that single-pulse transcranial magnetic stimulation (sTMS) may be an effective preventive treatment for migraine.
  • The study demonstrated a statistically significant reduction of 2.75 headache days per month compared to a performance goal (p < 0.0001).
  • 46% of participants experienced a 50% or greater reduction in headache days, alongside reduced acute medication use and improved HIT-6 scores.
  • sTMS was found to be safe and well-tolerated, with no serious adverse events reported during the study period.

eNeura SpringTMS Post-Market Observational US Study of Migraine

NCT02357381Completed
eNeura, Inc.
Posted 12/1/2014

Novartis' Sandoz Partners with Pear Therapeutics to Combat Substance Use Disorders with Digital Solutions

• Sandoz, a Novartis division, has partnered with Pear Therapeutics to commercialize reSET, the first FDA-approved mobile medical application for treating substance use disorders.
• The collaboration includes development of reSET-O, a specialized digital therapeutic for opioid use disorder patients undergoing buprenorphine treatment.
• This strategic partnership expands upon an existing collaboration between Novartis and Pear to develop digital therapeutics for schizophrenia and multiple sclerosis patients.

Alder BioPharmaceuticals to Present New Phase 3 Migraine Prevention Data for Eptinezumab

Alder BioPharmaceuticals announced it will present new Phase 3 data for eptinezumab, its lead investigational product for migraine prevention, at the 70th Annual American Academy of Neurology Meeting. The presentations will include data from the PROMISE 1 and PROMISE 2 clinical trials, highlighting eptinezumab's potential as a treatment option for migraine sufferers.

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