Bladder cancer study to develop predictive model for response to BCG

Ludwig Enterprises has received continuing review approval for its planned clinical study LL301, which will use mRNA and elisa-based cytokine/protein indices to evaluate pre- and post-treatment responses to BCG immunotherapyin patients with urothelial carcinoma of the bladder, announced the company in a news release.¹

The study will also utilize the company’s mRNA Inflammatory Index, which measures 48 different biomarkers of inflammation.

"We have looked forward to the launch of this study and are also pleased to announce that this research and potential breakthrough genetic results in BCG treatment of bladder cancer are covered in a filed international patent application. A personalized patient genetic index will be created to show the presence of bladder cancer as well as evaluate patient response to BCG immunotherapy,” said Ludwig Enterprises CEO Marvin S. Hausman, MD, in the news release.¹

The study was developed in partnership with Emerson Urology Associates,² and the trial first received Institutional Review Board approval in January 2023.³ The continuing review approval ensures that the trial can move forward as planned.

Overall, the study aims to develop a personalized score using mRNA genetic-based cytokines and related proteins to determine the efficacy of BCG immunotherapy in patients with urothelial carcinoma of the bladder. The L-genomic bladder cancer score would then be used to aid in disease management based on the predicted treatment response for each patient.

To this end, investigators will observe patients who have received treatment with BCG immunotherapy and measure their progress over time. This will allow the investigators to better understand how BCG immunotherapy works and the involvement of inflammation in the development of bladder cancer.

The study will also utilize the company’s mRNA Inflammatory Index, which measures 48 different biomarkers of inflammation. The platform, developed alongside Ludwig Enterprises’ subsidiary Precision Genomics, has a patent pending approval. The technology combines AI and deep machine learning to determine the degree of inflammation in each patient by measuring the levels of mRNA-expressed biomarkers, such as cytokines, which upregulate the inflammatory response. The investigators hope that this may enable physicians to identify potential sources of chronic inflammation and help in making treatment decisions for chronic illnesses such as cancer.⁴

In a prior news release on the study, Hausman concluded, “This ground-breaking research study has the potential to transform cancer detection and treatment by producing a predictive model for early-stage cancer occurrences. The proprietary genomic language developed could change medical care by capturing an individual snapshot of disease progression in combination with a patient’s response to certain treatments–enabling doctors to better serve their patients’ needs proactively rather than reactively. Ludwig intends to make this research program available to urology doctors and clinics throughout the United States.”³

References

1. Ludwig Enterprises mRNA bladder cancer study to be launched. News release. Ludwig Enterprises. January 31, 2024. Accessed February 14, 2024. https://www.biospace.com/article/releases/ludwig-enterprises-mrna-bladder-cancer-study-to-be-launched/

2. Ludwig Enterprises and Emerson Urology Associates Plan Bladder Cancer BCG Immunotherapy Study. News release. Ludwig Enterprises. September 20, 2022. Accessed February 14, 2024. https://www.biospace.com/article/releases/ludwig-enterprises-and-emerson-urology-associates-plan-bladder-cancer-bcg-immunotherapy-study/?keywords=ludwig+enterprises

3. Ludwig Enterprises receives IRB approval on bladder cancer study. News release. Ludwig Enterprises. January 3, 2023. Accessed February 14, 2024. https://ludwigent.com/ludwig-enterprises-receives-irb-approval-on-bladder-cancer-study/

4. Ludwig Enterprises mRNA program generating broad clinical interest. News release. Ludwig Enterprises. March 11, 2023. https://ludwigent.com/ludwig-enterprises-mrna-programgenerating-broad-clinical-interest/