Pharmacogenomics Leader to Test for TPMT Variants in Pediatric
Leukemia Patients; Applications in Clinical Research and Other Diseases
MORRISVILLE, N.C., April 7 /PRNewswire/ -- PPGx, Inc., a leading
international developer and supplier of research-based pharmacogenomics
services and products, has secured an exclusive worldwide license from St.
Jude Children's Research Hospital to test for mutations in the thiopurine
S-methyl transferase (TPMT) gene. PPGx is a joint venture of PPD, Inc.
(Nasdaq: PPDI) and Axys Pharmaceuticals, Inc. (Nasdaq: AXPH).
Researchers at St. Jude identified a subset of pediatric leukemia patients
with mutations in the TPMT gene who suffered severe, sometimes life-
threatening reactions to some common anti-cancer drug treatments. Severe side
effects seen in transplant patients receiving certain immunosuppressant drugs
are also caused by these mutations in TPMT. The test from PPGx will allow
physicians to screen for this mutation and adjust their patients' drug therapy
accordingly to protect against adverse events. In addition, the test will
allow researchers to continue evaluating the mutations of the TPMT gene in
clinical research.
"We are very pleased that PPGx will now make this diagnostic test readily
available to clinicians worldwide," said William Evans, Pharm.D., Deputy
Director, St. Jude Children's Research Hospital. "We have seen the importance
of determining the TPMT status of our patients and inpatients referred to us
for consultation, so we feel it is an important advancement for patient care
to now see this test become widely available as a clinical diagnostic."
Under the agreement, PPGx will market and sell TPMT clinical testing and
diagnostic services internationally through its pharmacogenomic testing
laboratories in Research Triangle Park, N.C., and Cambridge, England. In
addition, PPGx has been granted rights to develop and market the clinical
diagnostic technologies, including reagents and kits, as well as the right to
issue sublicenses for TPMT testing to third parties providing clinical
diagnostics for rheumatology, oncology and immunology.
"We are proud to be collaborating with some of the world's leading
leukemia experts at St. Jude to bring this critically important diagnostic
tool to physicians and clinical researchers worldwide," said PPGx President
and Chief Executive Officer Josh Baker, Ph.D. "A primary mission at PPGx is
turning pharmacogenomic research and technology into products and services
with direct impact on patient care -- and putting those resources into the
hands of healthcare professionals today. This is precisely what the St. Jude
licensing agreement enables PPGx to do."
Baker noted that the PPGx diagnostic for TPMT deficiency is among the
first of many pharmacogenomic tests to come that will benefit clinical
researchers and physicians in the treatment of disease. PPGx is the first
pharmacogenomics company to offer both GLP-compliant services and high
complexity clinical testing under CLIA regulations.
Common mutations in the TPMT gene alter its activity and prohibit some
people from metabolizing a class of drugs called thiopurines, used in the
treatment of cancer, arthritis, irritable bowel disease and immune suppression
(including transplant patients). One in 10 of all patients have low TPMT
activity, and one in 300 children with acute lymphoblastic leukemia have
essentially no TPMT activity, and when treated with thiopurines can experience
life-threatening events. The diagnostic from PPGx will help physicians
determine beforehand whether it is safe to treat their patients with
thiopurines.
The wildtype TPMT gene was discovered by Dr. Richard Weinshilboum at the
Mayo Clinic in Rochester, Minn. A patent has been issued and assigned to the
Mayo Clinic for the wildtype gene. The mutations in the TPMT gene that are
detected by the PPGx TPMT assay were discovered by Dr. William Evans of St.
Jude Children's Research Hospital. Sequences containing the mutations and
diagnostic assays using them are covered by an issued patent assigned to the
Hospital. PPGx has an exclusive license arrangement with St. Jude for rights
to practice diagnostic assays under the St. Jude patent.
Pharmacogenomics is the science of using genetic information to predict
the safety, toxicity and/or efficacy of drugs in individual patients or groups
of patients. Scientists have known for decades that there is a genetic basis
for the variable response of patients to drug therapy, and PPGx researchers
have been working for more than seven years to develop a number of genetic
tests to accurately predict how an individual will respond to treatment prior
to therapy.
About PPGx
PPGx (http://www.ppgx.com ) provides technical and consulting expertise in the
application of pharmacogenomics to optimize and accelerate drug discovery and
development. Combining genetic research technologies from its computational
and research divisions, GLP/CLIA global laboratory services and a
comprehensive bioinformatics platform, PPGx provides pharmacogenomic solutions
for biotechnology and pharmaceutical companies. A joint venture formed in
February 1999 between PPD, Inc. and Axys Pharmaceuticals, Inc., PPGx is
committed to the discovery of predictive genetic markers for use in clinical
trials to result in delivery of therapeutic and life-saving medicines. PPGx
pharmacogenomic services and products are exclusively marketed by PPD, Inc.
About St. Jude Children's Research Hospital
St. Jude Children's Research Hospital (http://www.stjude.org ), in Memphis,
Tenn., was founded by the late entertainer Danny Thomas. The hospital is an
internationally recognized biomedical research center dedicated to finding
cures for catastrophic diseases of childhood. The hospital's work is
supported through funds raised by the American Lebanese Syrian Associated
Charities (ALSAC). All St. Jude patients are treated regardless of their
ability to pay. ALSAC covers all costs of treatment beyond those reimbursed
by third party insurers and total costs for families who have no insurance.
SOURCE PPGx, Inc.
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Related links:
http://www.ppgx.com
CONTACT:
Roger Friedensen of Epley Associates,
919-877-0877, or friedensen@epley-ral.com , for PPGx, Inc., or
Deidre Malone of St. Jude Children's Research Hospital,
901-495-2434, or deidre.malone@stjude.org
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