Clinical Research Focus. 15th Edition
Clinical Trials in Bulgaria – Country Profile for 2023
Bulgaria, located in Southeastern Europe, boasts a mature healthcare system and a growing pharmaceutical industry. Based on the significant number of clinical trials conducted per capita, Bulgaria is recognized as one of Europe’s formidable clinical research hubs. There are currently 550 clinical trials being conducted in the country, acting as a further incentive to the Bulgarian Association of Clinical Research (BACR) to advocate for high standards in meeting all international requirements.
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An Enhanced Genetic Animal Model of Down Syndrome
Researchers at the National Institutes of Health have developed a new genetic animal model of Down syndrome that more closely mirrors the condition in humans. The new mouse model, known as Ts66Yah, shows milder cognitive symptoms than the standard mouse model, Ts65Dn, which has been used in preclinical studies for almost 30 years. The Ts65Dn mouse model’s genome contains 45 extra genes that are not relevant to human Down syndrome. The new Ts66Yah model was developed using CRISPR gene-editing technology to remove these extra genes, providing a more precise model for developing treatments to improve cognition in people with Down syndrome.
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Nasal Spray for Depression Shows Long-Term Efficacy
Janssen’s Phase IIIb study has demonstrated that SPRAVATO® (esketamine nasal spray) has achieved significantly higher remission rates compared to quetiapine extended-release for adults with treatment-resistant major depressive disorder (TRD). The results of the long-term study indicate that the nasally-delivered treatment achieved higher remission rates at Week 6 and higher response rates as early as on Day 15 of the study. Esketamine NS is an N-methyl-D-aspartate (NMDA) glutamate receptor antagonist, which has a different mechanism of action and method of delivery compared to other approved depression treatments. “…With a third of people with MDD not responding to treatment, the data shows that esketamine nasal spray may help a greater proportion of patients achieve response and remission over the long-term…” stated Dr Tamara Werner-Kiechle, EMEA Therapeutic Area Lead, Neuroscience and Pulmonary Hypertension, Janssen-Cilag GmbH.
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FDA Issues Draft Guidance Aimed at Improving Oncology Clinical Trials for Accelerated Approval
The US Food and Drug Administration (FDA) has issued draft guidance on clinical trial design considerations to support accelerated approval applications for oncology therapeutics. The guidance discusses ways to improve the data available at the time of accelerated approval, reduces clinical uncertainty for patients, and initiates post marketing confirmatory studies in a timely manner. The guidance suggests conducting two separate randomized controlled clinical trials or using one trial for both accelerated approval and to verify clinical benefit. It also provides considerations for sponsors to determine the adequacy of single-arm studies to support an application. The FDA has launched Project Confirm, an initiative that promotes transparency of outcomes related to accelerated approval for oncology indications and fosters discussion and research on the accelerated approval program.
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Clinical Trial Transformation Funds for Aberdeen Scientist
Dr Beatriz Goulao, a clinical trial scientist at the University of Aberdeen, has received a grant of more than £500,000 from the UK’s Medical Research Council and the National Institute for Health and Care Research. The grant will be used to fund a three-year project aimed at making clinical trials more patient-focused by bolstering patients’ and the public’s involvement in the research. Dr Goulao’s research program is aimed at making health statistics more relevant and impactful for patients. The project will develop methods that can be used across different clinical fields and will help large and diverse groups of patients. The ultimate aim of the project is to pinpoint the best NHS treatments through patient-focused research.
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New trigger for several mood disorders discovered
A new study published in journal Science has identified a common amino acid called glycine as a trigger for several mood disorders, including major depressive disorder. Researchers at the Herbert Wertheim UF Scripps Institute for Biomedical Innovation & Technology discovered a new glycine receptor called GPR158 that plays a role in stress-induced depression. Mice without the gene for the receptor were more resilient to chronic stress than mice with it. The discovery of this new trigger may pave the way towards new, faster-acting treatments for mood disorders.
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Translation of “Jumping Genes” Creates Cancer Therapy Targets
Researchers have suggested that transposable elements or “jumping genes” could help scientists identify tumor-targeting proteins, according to a study published in Nature Genetics. Transposable elements are short nucleotide sequences that can copy themselves into other regions of the genome, and during cancer, they can begin to “jump” to different regions of the genome, potentially making their way into genes and translating into tumor-specific antigens. These are proteins on the surface of tumors that mark the cell for immune destruction, making them a potential focus for cancer therapy development. The findings could help researchers design more universal cancer treatments.
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