C-Path, FDA, NCI to Develop Standards for Evaluating Companion Dx/Rx Submissions
The Critical Path Institute will use a $2.1 million Arizona state grant to work with the US Food and Drug Administration and the National Cancer Institute to standardize how companion diagnostics and therapies for cancer are evaluated.
“Currently, there is no proven development pathway for FDA approval of the necessary companion diagnostic tests and their associated targeted therapies,” said Ventana Medical Systems, which will test the resulting process. “The goal of this collaboration is to establish the performance standards that would serve as the model for future FDA co-submissions of these companion diagnostic tests and their targeted drug therapies.”
The collaboration intends to establish performance standards that the FDA could use for future co-submissions of companion diagnostics and cancer drugs. The first test to which the groups plan to apply the standards will be a Ventana-made diagnostic for lung cancer, the company said.
“The ultimate goal of the project is to guide the choice of targeted therapy so that patients receive the most effective treatments," C-Path CEO Raymond Woolsey said in a statement.
C-Path is a publicly funded non-profit based in Tucson, Ariz., that aims to help the FDA implement its Critical Path Initiative. The $2.1 million grant was awarded by Science Foundation Arizona.
NRC Calls for National Toxicogenomics Project; Aims Include New Genomic Tools, Database, Dxs
A new report by the National Research Council calls for a national “human toxicogenomics initiative” to better understand toxicity by developing genomic tools to identify toxic chemicals that predict “individual vulnerabilities,” creating new toxicity tests, and building a massive database to hold data about toxins and genomics.
Saying the effort should “approach the scale of the Human Genome Project,” the NRC said it will be necessary to develop toxicogenomic technologies, execute studies, and create data and biobanks, and to begin to confront ethical challenges in order to realize the potential of toxicogenomics contributions to modern medicine and science.
"We have just begun to tap the potential for toxicogenomic technologies to improve risk assessment," David Christiani, chair of the NRC’s Committee on Applications of Toxicogenomic Technologies to Predictive Toxicology, said in a statement.
New technologies now allow researchers to “identify toxic processes as they unfold at an early, molecular stage, long before symptoms appear,” the NRC said in the statement. Continuing to collect, store, and experiment with this type of information will make it easier to develop tests "that can more accurately predict whether a chemical will be hazardous, and at what dose.”
The NRC also proposed creating a “single public database to collect toxicogenomic data and integrate it with data on health effects generated with traditional toxicology studies.”
This database would allow researchers to study the links between molecular activity and symptoms they may cause, and to study how “multiple genetic reactions at the cellular level can combine to cause adverse outcomes.”
MIT Wins $100M Gift to Create Cancer Research Institute That Melds Genomics, Cell Bio, Engineering
The Massachusetts Institute of Technology said this week that an alumnus has awarded it a $100 million gift to create a new research center that will pool the school’s molecular genetics, cell biology, and engineering disciplines to study cancer.
The gift from Koch Industries executive David Koch will help build the David H. Koch Institute for Integrative Cancer Research, which will house genomics, cellular imaging, nanotech, and other technologies and employ around 25 scientists and engineers “to develop new ways to detect, diagnose, treat, and manage” cancer, MIT said this week in a statement.
The school said that among the center’s five target areas will be using genomics research along with imaging and micro-scale monitoring technologies to push cancer diagnosis and prevention to “earlier and earlier” stages of the disease.
It also said it will attempt to discover “specific vulnerabilities” of cancer cells through diagramming “key pathways,” engineering new nanotechnology, studying how tumors evade recognition by the immune system, and studying the “molecular and cellular basis for metastasis.”
MIT said the center is scheduled to open in 2010. Tyler Jacks, the David H. Koch Professor of Biology at MIT, will serve as the director of the Koch Institute.
Montreal Heart Institute to Use $5.1M Grant on PGx Studies for ACS Drug
The Montreal Heart Institute has been awarded a CAN$5 million ($5.1 million) grant to fund a research project based on its academic and private partnerships in pharmacogenomics, MHI said late last week.
The funding was awarded as part of a Genome Quebec competition aimed at fostering public and private participation in developing personalized medical technologies.
In a related announcement last week, VIA Pharmaceuticals said it has secured funding from Genome Quebec to perform a pharmacogenomics sub-study as part of clinical trials for its lead candidate for acute coronary syndrome.
VIA said it will collaborate with the Montreal Heart Institute to perform genomics and proteomics studies and develop a genotyping panel it could use in Phase II clinical trials for its ACS drug VIA-2291.
VIA, a San Francisco-based small-molecule drug developer, estimated that the program will cost around $5 million. The company will provide around $2.4 million in funding for the ACS clinical trial, and around $200,000 for costs related to the pharmacogenomics sub-study. Genome Quebec and other companies will provide the balance of the funding, the company said.
The project will focus on development of a 5 lipoxygenase genotyping panel and an ADME/tox panel for VIA-2291, VIA said.
"We believe that this sub-study will generate important information on the pharmacogenomics of our study patients, and will provide additional insight into the role we believe VIA-2291 will play in reducing vascular inflammation in ACS patients with atherosclerosis," VIA CEO Lawrence Cohen said in a statement.
Asuragen Licenses Roche's qRT-PCR IP for Drug Trials Work
Asuragen Pharmacogenomic Services this week said it has licensed real-time quantitative PCR technology from Roche Molecular Systems that will enable it to perform clinical gene-expression profiling and DNA analysis.
Asuragen said the IP, together with its microRNA and mRNA profiling services, can be used to test predictive biomarker signatures, efficacy markers, and assess patient stratification during clinical drug trials.
Financial terms of the agreement were not released.
USC to Lead $8.4M Effort to Study Autism Genotypes and Phenotypes
A group of institutions led by the University of Southern California has been awarded a five-year, $8.4 million grant from the National Institutes of Health to study genotype and phenotype variations of autistic children, USC said last week.
USC said it will use the funding to create a Center for Genomic and Phenomic Studies in Autism, and it will “increase the reach and ethnic diversity” of the Autism Genetic Resource Exchange, a repository of genetic information on families who have two or more children with autism.
The center will not be based at USC, but will be “a virtual center of sorts, which is part of the innovation,” explained Clara Lajonchere, a USC professor who specializes in autism and oversees the AGRE.
Much of the clinical and evaluative work will be performed in patients’ homes across the country, and some research requiring on-site work such as MRIs will be performed at the MIND Institute, Lajonchere added.
Working with USC on these autism studies are the MIND Institute at the University of California, Davis; Children’s Hospital Los Angeles; the University of Michigan at Ann Arbor; and the University of Massachusetts Medical School.
Thomas Lehner, who heads the NIH Genomics Research Branch, said one goal of the center is to “better distinguish among the many forms of autism and to explore the difference in their genetic profiles.”
“We are trying to establish a correspondence between gene and phenotype, with the phenotype being autism and its many manifestations,” Lehner said.