Hopeless .....
you get the BOOT minus the STOCKING ......
DNAPrint™ genomics, Inc. Forms Joint Research Program with the H. Lee Moffitt Cancer Center and Research Institute
SARASOTA, Florida, March 29, 2004/PRNewswire/ -- DNAPrint genomics (OTCBB: DNAP, the “Company”) of Sarasota, FL today announces that it has formed a multi-faceted pharmacogenomics program with the H. Lee Moffitt Cancer Center & Research Institute at the University of South Florida. The program will aim to develop and implement new clinical tests for predicting patient response to various cancer chemotherapies.
Moffitt physicians and scientists are teaming with DNAPrint to identify genetic variants that underlie poor patient response to various chemotherapies, and to implement new clinical tests at the Center combining these variants with other biomarkers from gene-expression, proteomics and epidemiological research. The aim of the tests will be to predict patient chemotherapy response from the DNA before the commencement of the chemotherapy, so that patients with a genetic proclivity for poor or non-response can be spared from exposure to ineffective therapy. With the newly signed agreement, both organizations have teamed to make an important stride towards their goal of enabling a more personalized, safe and effective modality of cancer treatment for our current generation of cancer patients.
The program is multi-faceted and presently defines study in several cancer areas and clinical programs. Research will draw from several ongoing clinical trials and epidemiology research projects underway at the Center. A primary area of focus for the program is colorectal cancer, where DNAPrint will work with primary investigator Dr. Timothy Yeatman, Moffitt’s Associate Center Director for Clinical Investigations. DNAPrint will implement its proprietary ADMIXMAP genetic discovery platform to define gene sequences predictive for response to two anti-cancer treatments, XELOX and XELIRI. Though representing current FDA-approved therapies for metastatic colon cancer, approximately 50% of patients fail to respond and given the poor prognosis associated with non-response, there is a dire need for tools capable of predicting response before hand. The study design will aim to first discover and then evaluate the predictive power of predictive Single Nucleotide Polymorphism (SNP) markers in tandem with biomarkers from gene expression chip and proteomics research currently under way at Moffitt. The first colon cancer study will involve 100 patients. Other phases of this particular project will permit a retrospective alignment of genetic risk and epidemiologic factors, and prospective evaluation of chemotherapy response prediction in the setting of GLP and FDA approved clinical trial setting.
Over all of the program areas, the collaboration will combine Moffitt oncologists, research scientists, mathematicians and software engineers with DNAPrint computer scientists, molecular biologists and population geneticists, and draw upon DNAPrint’s pharmaceutical, clinical and regulatory expertise. Moffitt will contribute gene expression and proteomics data resources currently in development and DNAPrint will contribute its ADMIXMAP platform and SNP analysis for mapping the genetic determinants of variable drug response by harnessing the power of human population genetic structure. ‘We have identified several clinical projects at the Moffitt that are of keen commercial and social interest,’ said Dr. Hector J. Gomez, MD, PhD, Chairman of the BOD and Chief Medical Officer of DNAPrint genomics, Inc. ‘Each of these programs offers us the opportunity to advance cancer treatment in a significant way,’ he said. Recent (November 2003) FDA guidance regarding pharmacogenomics technologies promulgate that if markers are validated using well understood markers in legitimate clinical environments, genetic tests derived from those markers should be included in new drug applications.
Moffitt sees thousands of cancer patients each year, and ranks with M.D. Anderson (Univ. Texas), Johns Hopkins (Baltimore, MD) and Fred Hutchinson (Seattle, WA) as among the nation’s busiest and most prestigious cancer research centers. The center has established a domestic and international network of collaborating physicians to build patient registries and implement cutting-edge methods for reducing, treating or preventing the onset of cancer diseases.
“Moffitt scientists and physicians were impressed with DNAPrint’s ADMIXMAP approach for using a populations’ structure as a fuel for mapping drug response gene variants. We recognized its profound potential for contributing to the enhancement of cancer treatment”, said Moffitt’s Dr. Timothy Yeatman.
Dr. Tony Frudakis, the scientific leader of DNAPrint and founder says, ‘By virtue of its broad scope and scale, and given its clinical setting, this is by far the most exciting research and product development opportunity yet for our young company. Our goal is simple - to present the FDA with what we can do and to pave the way for our brand of personalized medicine as the gold standard for drug development and use.’ He added, ‘The signing of this deal illustrates Dr. Gomez’s regulatory experience and leadership in the clinical development and pharmaceutical product approval process. This is invaluable to us as a company, as he brings a real world experience to our development programs.’
IMAGINE 100 PATIENTS AND NOW WE GO THE PUBLIC IN FLORIDA --- GEO
AI
