PPGx Secures Exclusive Worldwide License for TPMT Testing From St. Jude Children's Research Hospital
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 (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 (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.
CO: St. Jude Children's Research Hospital; PPGx, Inc.; Axys Pharmaceuticals, Inc.; PPD, Inc.
ST: North Carolina, Tennessee
IN: HEA MTC
SU: LIC
04/07/2000 07:01 EDT prnewswire.com |