FNIH Launches New Projects

The Foundation for the National Institutes of Health (FNIH) https://fnih.org recently launched a new project to shorten the treatment times for Tuberculosis (TB) in drug-sensitive patients which uses individualized therapy.

The $24 million project “Using Biomarkers to predict TB Treatment Duration” (PredictTB) http://fnih.org/PredictTB is funded in part by the FNIH through a $13 million donation from the Bill & Melinda Gates Foundation www.gatesfoundation.org. Management support will be provided by the National Institute of Allergy and Infectious Diseases (NIAID) within NIH https://www.niaid.nih.gov and Catalysis Foundation for Health https://catalysisfoundation.org.

Additional support for Predict TB from the European & Developing Counties Clinical Trials Partnership www.edctp.org, will be executed through Stellenbosch University www.sun.ac.za/englich and LINQ Management www.ling-management.com.

Grand Challenges China www.grandchallenges.org, and the NIH International Infectious Disease Research Program is collaborating with the Consortium for TB Biomarkers and the Regional Prospective Observational Research in TB www.crdfglobal.org.

The PredictTB project will enroll up to 620 patients with drug sensitive pulmonary TB in a clinical trial with five collaborating sites in Cape Town South Africa and four sites in Henan Province, China. Initial results from PredictTB are expected in January 2023.

In addition, the Biomarkers Consortium https://fnih.org/waht-we-do/biomarkers-consortium at FNIH has launched a new research partnership to develop new methods to analyze digital images seeking new ways to track a patient’s response to cancer therapy.

Following a one year Biomarkers Consortium pilot that established feasibility for the project, FNIH was able to raise $2.7 million from partners in the private sector to support the new project called “Advanced Metrics and Modeling with Volumetric CT for Precision Analysis of Clinical Trial Results” or referred to as (Vol-PACT).

This project is the first of its kind to procure imaging data from multiple completed, pharmaceutical industry-sponsored Phase II/III clinical trials to identify novel drug response metrics. The Vol-PACT project team is going to analyze the imaging data from these trials to measure characteristics of cancer progress and to generate potential biomarkers.

The project is going to compare the new imaging biomarkers to the current standards used for therapies that target specific genes and proteins as well as those that stimulate immune response. The research has the potential to improve the accuracy and efficiency of future clinical trials across multiple treatments and cancer types and also accelerate cancer therapeutic development so physicians will be able to provide better treatments to cancer patients.