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Tuesday, December 4, 2012
NIH BrIDGs program helps overcome research roadblocks
tudies launched to advance therapeutics targeting cancers, spinal cord injury and a rare disease.
Potential new treatments for a variety of cancers, spinal cord injury, and a rare disease that can lead to kidney failure are targets of a program that provides eligible scientists with no-cost access to National Institutes of Health therapeutic development contractor resources.
Often, researchers apply to this NIH program, called Bridging Interventional Development Gaps (BrIDGs), because there is a lack of private resources or they have hit a roadblock and need additional expertise. Rather than funding successful applicants directly, BrIDGs enables NIH contractors to provide pre-clinical services — such as toxicology studies — for therapeutic projects that have demonstrated efficacy in a disease model.
BrIDGs, formerly known as NIH Rapid Access to Interventional Development, is supported by the NIH Common Fund. In addition, NIH Institutes and Centers at times contribute funding to support projects relevant to their missions. The eight-year-old program is led by the NIH’s National Center for Advancing Translational Sciences (NCATS).
For the majority of projects, the goal is to enable the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration. Human clinical trials using an investigational new drug may commence within 30 days of the submission of an IND for that drug unless the FDA informs the sponsor that the IND is subject to a clinical hold. To date, BrIDGs has generated data to support 12 INDs submitted to the FDA, and one clinical trial application to Health Canada. Twelve of the 13 projects have been evaluated in clinical trials. Three BrIDGs-supported therapeutic agents have gone as far as Phase II human clinical trials, in which researchers give an experimental therapy to a group of patients to evaluate the effectiveness and safety of a treatment. Third-party investors have licensed six agents during or after their development by BrIDGs.
"I am excited by the high success rate of this program," said Christopher P. Austin, M.D., director of NCATS. "As its name implies, the program bridges the gap between a basic discovery and clinical testing by providing the expertise needed to perform crucial pre-clinical studies, often breathing new life into projects that otherwise may never reach patients."
BrIDGs selected the following new projects from its 2012 application solicitation:
Tumor Penetrating Microparticles for Peritoneal Cancers
Jessie Au, Pharm.D., Ph.D., chief scientific officer and acting chief executive officer
Optimum Therapeutics, LLC, San Diego
This project focuses on cancers that affect organs in the peritoneal cavity such as the bladder, liver and pancreas. A drug delivery system, called tumor-penetrating microparticles, is under development to target peritoneal tumors.
Lecithin-cholesterol acyltransferase (LCAT) deficiency syndrome
Development of Assays to Detect Anti-drug Antibodies against ACP-501 (recombinant human LCAT)
Brian Krause, Ph.D., chief scientific officer
Alphacore Pharma, LLC, Ann Arbor, Mich.
Lecithin-cholesterol acyltransferase deficiency syndrome is a rare disorder that causes a drastic reduction of high-density lipoprotein (HDL) cholesterol levels in patients. This leads to disorders of the cornea (the transparent lens on the eye), anemia, and may cause kidney failure. The objective of this project is to develop a treatment called recombinant human LCAT that would act as a replacement therapy to offset the deficiency caused by LCAT deficiency syndrome.
Spinal Cord Injury
Development of Nogo Receptor Decoy for the Treatment of Spinal Cord Injury
George Maynard, Ph.D., vice president, Preclinical Development
Axerion Therapeutics, Inc., New Haven, Conn.
Recovery after a spinal cord injury is limited, as nerve cell growth is virtually nonexistent in the adult spinal cord. This project aims to develop a compound called Nogo Receptor Decoy to rewire nerve cells that promote the recovery of neurological function. The NIH's National Institute of Neurological Disorders and Stroke is co-funding the pre-clinical studies for this project.
"The success of BrIDGs demonstrates there is a vital need in the research community for the services offered through the program and speaks to the quality of the projects it supports," said John McKew, Ph.D., chief of the NCATS Therapeutics Development Branch. "While not all projects will make it as treatments, the support gained through BrIDGs provides each with a shot at success."
BrIDGs solicits applications once a year. The next opportunity to submit applications is from Dec. 1, 2012 to Feb. 1, 2013. The BrIDGs application process will move to the proposalCENTRAL application system, which is a streamlined application process used by some of NIH’s programs.
Information about BrIDGs, including application instructions, is available at http://www.ncats.nih.gov/research/rare-diseases/bridgs/bridgs.html.
The National Center for Advancing Translational Sciences (NCATS) aims to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. For more information about NCATS, visit http://www.ncats.nih.gov.
The National Institute of Neurological Disorders and Stroke (NINDS) is the nation’s leading funder of research on the brain and nervous system. The NINDS mission is to reduce the burden of neurological disease – a burden borne by every age group, by every segment of society, by people all over the world. For more information about NINDS, visit http://www.ninds.nih.gov.
The NIH Common Fund supports a series of exceptionally high-impact research programs that are broadly relevant to health and disease. Common Fund programs are designed to overcome major research barriers and pursue emerging opportunities for the benefit of the biomedical research community at large. The research products of Common Fund programs are expected to catalyze disease-specific research supported by the NIH Institutes and Centers. Additional information about the NIH Common Fund can be found at http://commonfund.nih.gov.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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