Clinical Trial News
FDA Grants Full Approval to Blinatumomab for B-cell Precursor ALL
The FDA has fully approved blinatumomab (Blincyto) for treating adults and children with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (ALL), regardless of Philadelphia chromosome status. This approval is based on data from the phase III TOWER study, showing improved overall survival rates compared to standard chemotherapy.
Patient-Centric Approaches and Technology Reshape Clinical Trial Landscape, Industry Experts Report
- Only 39% of clinical trial sites achieve enrollment targets according to Tufts Center, highlighting critical recruitment challenges in drug development.
- Industry leaders from INC Research, DrugDev, and EMD Serono emphasize the importance of non-traditional partnerships and patient-focused technology solutions to improve trial participation.
- Experts advocate for incorporating patient feedback through advisory boards and focus groups, while cautioning that technology solutions must be tailored to specific patient populations' needs.
Manali Kamdar's Contributions to Lymphoma Treatment Research
Dr. Manali Kamdar, Clinical Director of Lymphoma Services at the University of Colorado Cancer Center, focuses on novel therapies for non-Hodgkin lymphoma, participating in significant clinical trials like TRANSFORM and TRANSCEND-NHL-001.
Highlighted Clinical Trials:
Juno Therapeutics, a Subsidiary of Celgene
Posted 1/6/2016
Soleno Therapeutics Gains FDA Support for DCCR Trial Design in Prader-Willi Syndrome
- Soleno Therapeutics received positive feedback from the FDA regarding its Phase III trial design for Diazoxide Choline Controlled-Release (DCCR) in Prader-Willi Syndrome (PWS).
- The FDA supports using change in hyperphagia score as the primary endpoint, without requiring a change in weight, compared to placebo.
- The FDA agreed to a shorter 3-4 month randomized, double-blind, placebo-controlled study, with long-term safety data collected separately.
- Soleno plans to finalize the Phase III trial design, aiming to enroll approximately 100 patients, with study initiation expected by the end of 2017.
GSK Partners with Exscientia in £33M AI-Driven Drug Discovery Alliance
- GlaxoSmithKline has formed a strategic alliance with UK-based Exscientia to leverage artificial intelligence for accelerating drug discovery across 10 disease areas, with potential milestone payments of £33 million.
- Exscientia's AI platform has demonstrated ability to deliver candidate molecules in one-quarter of the traditional time and cost, promising significant efficiency gains in early-stage drug development.
- The collaboration builds on Exscientia's growing portfolio of partnerships, including recent €250M Sanofi deal, positioning the company as a leading AI-driven drug discovery innovator.
Alder BioPharmaceuticals Announces Positive Eptinezumab Phase 3 Results for Migraine Prevention
Alder BioPharmaceuticals has reported positive top-line results from its Phase 3 PROMISE 1 clinical trial for eptinezumab, a treatment aimed at preventing frequent episodic migraines. The trial met its primary and key secondary endpoints, showing significant reductions in monthly migraine days and a notable proportion of patients experiencing no migraines in any given month over six months.
Immunotherapy for Glioblastoma Shows Promise in Early Study
A phase 1 study involving 11 glioblastoma patients treated with a dendritic cell vaccine and chemotherapy showed the combination was well tolerated and resulted in significant survival gains, with some patients surviving over 5 years. The study, published by Duke researchers, suggests potential benefits of combining immunotherapy with intensified chemotherapy regimens.
Clinical Trial Data Sharing Initiatives Drive Innovation and Efficiency in Drug Development
- TransCelerate's Placebo & Standard of Care Data Sharing Initiative has established a repository containing data from 67,000 patients across 90 clinical trials, reducing study time by 30% in preliminary results.
- Industry-wide momentum for clinical trial data sharing is growing, with major stakeholders including FDA, EMA, and medical journals implementing new policies to promote transparency and collaboration.
- The Comparator Network Initiative has facilitated over $120 million in transactions, achieving 10-12% cost savings while enhancing drug supply chain safety and reducing investigational product waste.
Actinium Pharmaceuticals' Actimab-A Receives Orphan Designation in the EU for AML Treatment
- Actimab-A has been granted orphan designation in the European Union by the EMA for treating newly diagnosed AML patients over 60 ineligible for standard induction therapy.
- The orphan designation provides Actinium with increased regulatory communication, guidance, and potential for 10-year market exclusivity in the EU upon marketing authorization.
- Actimab-A targets CD33, a protein expressed on AML cells, using the monoclonal antibody HuM195 linked to the radioisotope actinium-225, delivering targeted alpha particle immunotherapy.
- A multi-center Phase 2 clinical trial is currently enrolling 53 patients to evaluate Actimab-A as a first-line therapy for elderly AML patients who lack effective treatment options.
Dynamic Consent Platforms: Revolutionizing Clinical Trial Participation and Data Management
- Dynamic consent technology enables personalized online platforms for managing informed consent in clinical trials, allowing participants to update their preferences and maintain ongoing dialogue with researchers.
- A pioneering app developed at Radboud University Medical Centre empowers patients to create custom data-sharing policies and manage consent preferences through an intuitive mobile interface.
- Implementation of dynamic consent platforms could significantly improve trial recruitment, participant retention, and data management efficiency while addressing current challenges in biomedical research participation.