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NIH Issues Two New Funding Opportunities, and Reissues an Older One, All with RNAi Potential

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The National Institutes of Health issued two new funding opportunity announcements late last month for projects focused on the impact of cellular, molecular, and genomic technologies on cancer care and non-viral gene transfer systems, both of which specifically name RNA interference as a research avenue.

The NIH also reissued an FOA for grants focused on Alzheimer's disease drug discovery, which also cites RNAi as a key area of research.

The first FOA, which is being overseen by the National Cancer Institute, is seeking grant applications that propose to conduct health services research examining the use of both experimental and existing cellular, molecular, and genomic technologies in cancer care.

"To date, cancer research in the emerging field of molecular medicine has primarily focused on the discovery of novel biomarkers and therapeutic targets, and the development of innovative biotechnologies to improve cancer prevention, early detection, diagnosis, and treatment," the NIH stated in the FOA. "Faced with a rapidly expanding developmental pipeline, the applied cancer research community has recently begun to address, on a limited scale, the organizational and cost implications of integrating [cellular, molecular, and genomic] technologies into clinical care.

"This funding opportunity aims to stimulate and support research to improve understanding of access, quality, and costs associated with utilization of [these] technologies across the cancer care continuum," the NIH added.


"This funding opportunity aims to stimulate and support research to improve understanding of access, quality, and costs associated with utilization of [these] technologies across the cancer care continuum."

Specifically, the funding opportunity is geared towards projects assessing technologies in relation to quality of care; organizational barriers and change factors in utilization; cost and cost-effectiveness; disparities in access and efficacy; monitoring of cross-sectional patterns of care and time trends; impact on existing standards of care; and influence on cancer outcomes such as incidence, progression, mortality, survival, and quality of life, according to the NIH.

"The clinical tools in scope for this initiative should be directly applicable to cancer prevention, early detection, diagnosis, or treatment … [and] should also be targeted to specific DNA or RNA sequences, or other specific biological molecules or pathways," the NIH stated.

Examples of technologies considered relevant to the funding opportunity include molecular assays to predict treatment outcomes, nanoparticle drug delivery systems, RNA interference, and toxicity and efficacy biomarker assays for monitoring treatment response and drug resistance.

The FOA is designed to support projects with a maximum duration of two years, with total direct costs limited to $275,000.

The second FOA is being overseen by the National Heart, Lung, and Blood Institute and is calling for grant applications focused on the development of new non-viral vectors that can "overcome the limitations of viral vectors for gene therapy clinical trials in heart, lung, and blood diseases," according to the NIH.

"Non-viral gene delivery systems offer an alternative strategy and have the potential to provide nucleic-acid based therapeutics that closely resemble traditional pharmaceuticals and ameliorate some of the more common limitations with viral vectors," the NIH said in the FOA. "Two promising classes of non-viral vectors are the nanoparticles, [which] are condensed from DNA and can be internalized by cells, and matrices or micro/nanoparticles that can entrap DNA for sustained release. This delivery method is receiving increasing attention because of ease of synthesis, low immunogenicity, and unrestricted plasmid size."

The NIH added that an additional benefit of non-viral vectors over their viral counterparts is their versatility. "Rigidity, hydrophobicity, charge density, biodegradability, and molecular weight of non-viral vectors are all parameters that can be adjusted to achieve an optimal composite with DNA," the institute said.


"Non-viral gene delivery systems offer an alternative strategy and have the potential to provide nucleic-acid based therapeutics that closely resemble traditional pharmaceuticals and ameliorate some of the more common limitations with viral vectors."

The funding opportunity is designed to stimulate the development on new non-viral vectors that can be used in the clinic, the NIH said, noting that "high-risk" applications are encouraged with the "innovative nature of the application" being emphasized in the review process. The FOA specifically cites RNAi-based delivery methods as an example of a relevant research topic.

Grant applications submitted under the FOA are to be organized into two phases, with a combined duration of no more than five years. Annual direct costs under the first phase are limited to a maximum of $250,000, while direct costs under the second phase are limited to no more than $500,000 per year.

The last FOA, which is a re-issue of a funding opportunity released in November 2004, is designed to support the testing of novel compounds for the treatment and prevention of cognitive impairment and behavioral symptoms associated with Alzheimer's disease. It is being overseen by the National Institute on Aging, the National Institute of Mental Health, and the National Institute of Neurological Disorders and Stroke.

"The objective of this solicitation is to stimulate preclinical research in the discovery, design, development, and testing of novel compounds aimed at slowing, halting, or, if possible, reversing the progressive decline in cognitive function and modifying the behavioral symptoms in Alzheimer's disease as well as delaying the onset of or preventing" the disorder, the NIH said in the FOA. "This initiative is intended to stimulate basic research and development efforts. The goal is not to duplicate or compete with pharmaceutical companies but to encourage, complement, and accelerate the process of discovering new, innovative, and effective compounds for the prevention and treatment of the cognitive impairment and behavioral symptoms associated with Alzheimer's disease."

The FOA seeks projects that involve the design, synthesis, and preclinical testing of compounds that alter, modify, or regulate the various aspects of neuronal mechanisms associated with Alzheimer's disease, including gene expression and transcription using RNAi.

Grant applications under the FOA may have a term of no longer than two years, with total direct costs of up to $275,000.

— Doug Macron ([email protected])