DNAP .043.News. "Moffitt scientists and physicians were impressed with DNAPrint's ADMIXMAP
approach for using a population's 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."
(PR NEWSWIRE) DNAPrint(TM) genomics, Inc. Forms Joint Research Program With the
H. Lee Moffitt Cancer Center and Research Institute
DNAPrint(TM) genomics, Inc. Forms Joint Research Program With the H. Lee Moffitt
Cancer Center and Research Institute
SARASOTA, Fla., March 29 /PRNewswire-FirstCall/ -- DNAPrint genomics
(OTC Bulletin Board: DNAP) (the "Company") of Sarasota, FL today announced
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
beforehand. 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 population's 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."
About DNAPrint genomics, Inc.
DNAPrint genomics, Inc. uses proprietary human genome research methods to
develop and sell genomic-based services. The Company introduced AncestrybyDNA
in the consumer market and DNA Witness in the forensic market in 2003.
DNAPrint is developing products in the pharmacogenomic market and has a
disease gene discovery program. The Company is traded on the Nasdaq OTC
Bulletin Board under the ticker symbol: DNAP. For more information about the
company, please visit www.dnaprint.com.
All statements in this press release that are not historical are forward-
looking statements within the meaning of Section 21E of the Securities
Exchange Act as amended. Such statements are subject to risks and
uncertainties that could cause actual results to differ materially from those
projected, including, but not limited to, uncertainties relating to
technologies, product development, manufacturing, market acceptance, cost and
pricing of DNAPrint's products, dependence on collaborations and partners,
regulatory approvals, competition, intellectual property of others, and patent
protection and litigation. DNAPrint genomics, Inc. expressly disclaims any
obligation or undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change in
DNAPrint's expectations with regard thereto or any change in events,
conditions, or circumstances on which any such statements are based.
Media and Press Contacts
Richard Gabriel
DNAPrint genomics, Inc.CEO/President(941) 366-3400
SOURCE DNAPrint genomics, Inc.
-0- 03/29/2004
/CONTACT: Richard Gabriel, CEO and President, DNAPrint genomics, Inc.,
+1-941-366-3400/
(DNAP)
CO: DNAPrint genomics, Inc.; H. Lee Moffitt Cancer Center and Research
Institute
ST: Florida
IN: MTC OTC
SU: JVN
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