The PREVENT Cancer Drug Development Program is a National Cancer Institute-supported pipeline to bring new cancer PREVENTing interventions and biomarkers through preclinical development towards clinical trials. (See Structure and Governance.)
PREVENT is an active NCI partnership with successful applicants to enable the milestone-driven progression of novel cancer PREVENTive chemical or biological agents (singly or in combination) and biomarkers from the lab bench towards proof-of principle clinical testing and registration or validation.
PREVENT is a flexible entry-point system that will optimize and test an agent depending on the stage of development, with the goal of filing an Investigational New Drug Application with the U.S. Food and Drug Administration and entering it into clinical testing.
PREVENT will support the development of potential cancer PREVENTive agents using mechanism-based assays in vitro and in vivo, as well as defining efficacy, including pharmacodynamics or surrogate endpoint biomarkers of validated, or yet to be studied, chemoPREVENTive agents. These assays shall evaluate the potential of test agents to inhibit, reverse, or delay early carcinogenesis through a variety of endpoints, such as histopathology, imaging and/or molecular endpoints, and identify potential targets or molecular pathways, including transformation, proliferation, and apoptosis, using state-of-the-art experimental methodologies. The main objectives of these studies are to prioritize and validate potential chemoPREVENTive agents and surrogate endpoints for toxicological/pharmacokinetics/pharmacodynamics evaluation and ultimately for their use in clinical PREVENTion trials. Support is also provided for drug synthesis, formulation, and stability studies.
The actual work of an approved application will be carried out under separate contract task orders. These task orders may or may not be awarded to the applicant or their institution. The PREVENT Program application will not directly lead to a grant or contract award; rather NCI may allocate various contract resources and expertise towards implementation and development of approved, scientifically meritorious projects. Researchers in academia, government, industry, nationally and internationally are encouraged to apply.
Recently, the Division of Cancer PREVENTion (NCI) has identified two areas of focus regarding drug development. These two key areas are likely to yield high return on investment in a relatively short time period in these times of economic restraint at NCI. The DCP focus for at least the next year will be on agent development efforts which lead to highly successful clinical Phase 2 trials within a short time frame.
The first area of focus is development of anti-inflammatory approaches to cancer PREVENTion. Inflammatory processes significantly contribute to driving the cancer process from early through late stages in a variety of organs. This approach appears particularly promising given the efficacy of NSAIDs and coxibs in both preclinical and clinical studies. Therefore, mechanism-based agents, approaches, or potential biomarkers relevant to blocking the inflammation pathways would be of greater interest to the DCP PREVENT Program.
The second area of DCP focus is in immunoPREVENTion. The development of vaccines against early cancers appears feasible and has great promise in preclinical studies. There has been a substantial amount of recent data relative to the use of vaccines or activated T-cells in a therapeutic setting which makes the whole area appear more promising and ripe for exploitation. This approach would offer an excellent strategy to combat the early cancer process with minimal toxicities. Biological agents such as vaccines against various cancers, as well as relevant biomarkers for use in vaccines, would be of high interest to the DCP PREVENT Program.
Resources PREVENT can provide:
- In vitro and in vivo preclinical pharmacology and efficacy studies
- Preclinical Investigational New Drug (IND)-directed GLP toxicology studies
- Identification and evaluation of intermediate biomarkers
- Scale-up cGMP and non-cGMP production of an investigational agent
- PK and PK-PD modeling to optimize dosing regimen
- Formulation optimization for enhanced bioavailability and clinical usefulness
- Analytical method development for investigational agents in bulk form and in biological fluids and tissues
- Stability testing for bulk and formulated material
- Regulatory support
- Other resources to support drug development
Submission deadlines occur twice per year on the first Monday in March and September.
For more information, please contact: NCIPREVENT@mail.nih.gov
The PREVENT Program
ChemoPREVENTive Agent Development Research Group
Division of Cancer PREVENTion, NCI
9609 Medical Center Drive
Bethesda, MD 20892-9787