SALT LAKE CITY, Jan 25, 2010 (GlobeNewswire via COMTEX News Network) -- Myriad Genetics, Inc. (Nasdaq:MYGN) announced that a presentation entitled: "Extensive 5-FU Inter-Patient Pharmacokinetic Variability May Result in Suboptimal 5-FU Dosing of Metastatic and Adjuvant Colon Cancer Patients on FOLFOX Regimens," was presented on Sunday, January 24th, 2010, at the Seventh Annual Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology (ASCO) in Orlando, Florida. 5-fluorouracil (5-FU) is a backbone of many chemotherapy regimens, including FOLFOX (folinic acid, fluorouracil and oxaliplatin), FOLFOX6, and FOLFIRI (folinic acid, fluorouracil and irinotecan), and is used extensively in the treatment of colorectal, metastatic breast, and head and neck cancers.
The study investigated the chemotherapic dosing of 150 colon cancer patients in the United States, including 102 patients who received FOLFOX6 and 48 patients who received FOLFOX6 plus Avastin. The results showed that when 5-FU is administered in combination with oxaliplatin according to current standard-of-care body surface area (BSA) dosing, 81.3% of the colon cancer patients had 5-FU exposure levels outside the optimal therapeutic range (Gamelin, et al., Journal of Clinical Oncology). Additionally, 28.7% of the patients showed elevated exposure to the drug, from too high of a dose of 5-FU and resulting in increased risk of toxicity, including diarrhea, oral mucositis, and hand and foot syndrome, and 52.6% of the patients exhibited a suboptimal 5-FU exposure, receiving too little drug and potentially resulting in the inadequate treatment of their cancer. These data are particularly important because they are based on measurements of drug exposure in actual community practice settings and they represent the largest data set of its kind in monitoring the treatment of colon cancer patients.
"This work demonstrates the large variability in 5-FU exposure that exists among colon cancer patients in the U.S. receiving 5-FU when dosed according to conventional protocols," stated Edward Chu, M.D., Deputy Director of the Yale Cancer Center. "This variability in exposure puts patients at risk of receiving too much or too little drug and highlights the importance of a laboratory test such as OnDose(TM) to monitor patient exposure to 5-FU in order to individualize dosing."
Studies conducted during the last two decades show that there is tremendous pharmacokinetic variability in the way that patients metabolize 5-FU, with as much as a 30-fold difference in clearance of and resulting exposure to 5-FU during the course of treatment. Colon cancer patients in this U.S.-based study also exhibited substantial variability in their drug exposure as determined by OnDose(TM). A consequence of this variability among patients is the difficultly for physicians using conventional BSA dosing methods to strike an optimum balance between achieving maximum efficacy in treating the cancer, and, at the same time, avoiding serious toxicity in a particular patient.
"This study confirmed previous research that a majority of colon cancer patients do not receive an appropriate dose of 5-FU," noted Dr. Gregory C. Critchfield, President of Myriad Genetic Laboratories. "We believe that our OnDose(TM) diagnostic test, which accurately measures a patient's exposure to 5-FU, will save lives and improve the quality of life for patients with colon cancer."
OnDose is a simple blood test that helps oncologists optimize infusional 5-FU therapy for colon cancer patients by measuring a patient's actual exposure to the chemotherapeutic drug, 5-FU. In a phase 3, multicenter, randomized study in 208 colon cancer patients published by Gamelin et al. in the May 2008 Journal of Clinical Oncology, dosing using OnDose's pharmacokinetic monitoring technology significantly improved drug efficacy and reduced toxicity. Objective response rates for these patients were nearly double that of conventionally dosed patients (33.6% versus 18.3%; p = 0.0004) and grade 3/4 toxicity events were 83% higher in the conventionally dosed patients versus those that were monitored using the OnDose technology (p = 0.003). Importantly, patients dosed using the OnDose technology survived 6 months longer than those dosed using the Body Surface Area dosing, the current standard of care. In the United States alone, 175,000 colon cancer patients may benefit from OnDose optimization of 5-FU infusion therapy each year.
About Myriad Genetics
Myriad Genetics, Inc. is a leading molecular diagnostic company focused on developing and marketing novel predictive medicine, personalized medicine and prognostic medicine products. Myriad's news and other information are available on the Company's Web site at www.myriad.com.
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Myriad, the Myriad logo, BRACAnalysis, Colaris, Colaris AP, Melaris, TheraGuide, Prezeon, and OnDose are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign countries. MYGN-G
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the extent and degree of the large variability in 5-FU exposure that exists among colon cancer patients in the U.S. receiving 5-FU when dosed according to conventional protocols as demonstrated by this work; the extent and degree to which this variability in exposure puts patients at risk of receiving too much or too little drug; the importance of a laboratory test such as OnDose(TM) to monitor patient exposure to 5-FU in order to individualize dosing; the Company's belief that the OnDose(TM) diagnostic test, which accurately measures a patient's exposure to 5-FU, will save lives and improve the quality of life for patients with colon cancer; and the ability of the OnDose(TM) diagnostic test to save lives and improve the quality of life for patients with colon cancer. These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic products may decline or will not continue to increase at historical rates; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic products; the risk that licenses to the technology underlying our molecular diagnostic products and any future products are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with manufacturing our products or operating our laboratory testing facilities; risks related to public concern over our products; risks related to regulatory developments or enforcement in the United States and foreign countries and changes in the structure of healthcare payment systems; uncertainties about our ability to obtain new corporate collaborations and acquire new technologies on satisfactory terms, if at all; the development of competing products and services; the risk that we or our licensors may be unable to protect the proprietary technologies underlying our products; the risk of patent-infringement claims or challenges of our patents; risks of new, changing and competitive technologies and regulations in the United States and internationally; and other factors discussed under the heading "Risk Factors" contained in Item 1A in our Annual Report on Form 10-K for the year ended June 30, 2009,which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.
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SOURCE: Myriad Genetics, Inc.
CONTACT: Myriad Genetics, Inc. Suzanne Barton, Director, Investor Relations (801) 584-1138 firstname.lastname@example.org
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