Healthcare Industry News: BRCA2
News Release - October 24, 2006
Myriad Genetics Sponsors Clinical Trial in Pancreatic CancerStudy May Lead to New Personalized Medicine Product
SALT LAKE CITY, Oct. 24 (HSMN NewsFeed) -- Myriad Genetics, Inc. (Nasdaq: MYGN ), announced today that the Company is providing the genetic testing component of a new clinical trial in patients with pancreatic cancer being run by researchers at Johns Hopkins University. The trial will enroll patients with previously untreated, advanced or recurrent pancreatic cancer and a mutation in the BRCA2 gene. The BRCA2 gene confers greatly increased risk of breast and ovarian cancer in addition to a substantial increase in pancreatic cancer risk. Previous studies showed that pancreatic tumors from patients with a BRCA2 gene mutation were approximately 1,000 times more sensitive to mitomycin-C than were tumors from patients without the BRCA2 gene mutation. If this study confirms these data, then a diagnostic test to determine the BRCA2 status of the pancreatic cancer patients may be indicated to determine the appropriate chemotherapy prior to initiating treatment in pancreatic cancer.
Mitomycin-C is one member of an important class of DNA damaging agents used to treat cancer. BRCA2 is part of the DNA repair process. When mitomycin-C damages the DNA in a patient's cancer cells, the damage would normally be repaired with the help of BRCA2. If there is no BRCA2 to fix the DNA, because of a BRCA2 gene mutation, the mitomycin-C damage is not repaired, the cancer cells die and the drug is more effective. The clinical trial now underway is designed to determine whether the extreme sensitivity of the pancreatic cancer to mitomycin-C holds true in humans as it did in earlier studies. A total of 35 patients with BRCA2 mutations will be enrolled for treatment with mitomycin-C during the course of the study. The study will compare the six-month survival rate of treated patients with the current survival rates from standard of care therapy to determine the potential benefit of using mitomycin-C for people with BRCA2 gene mutations. Previous study results led the researchers to expect a substantial improvement in the six-month survival time of pancreatic cancer patients.
Current drug therapies do little to stop the progress of pancreatic cancer. The 38,000 individuals diagnosed each year in the U.S. are typically found to have advanced cancer and the mortality rate is alarmingly high. Approximately 7% of these cancers are due to mutations in BRCA2.
"We are very excited to participate in this important drug trial that we believe will provide validation for a novel personalized medicine product from Myriad," said Gregory Critchfield, M.D., President of Myriad Genetic Laboratories, Inc. "The study will explore the value of personalized drug therapy based on the BRCA2 mutation status of a pancreas cancer patient. If successful, pancreas cancer patients would be tested for BRCA2 mutations before instituting therapy. There is a tremendous opportunity to provide a targeted alternative treatment to patients with pancreatic cancer, something that is desperately needed at present."
The clinical trial is led by principal investigators Manuel Hidalgo, M.D., Ph.D. and Scott Kern, M.D., and is enrolling at Johns Hopkins University in Baltimore, M.D.
Myriad Genetics, Inc. is a biopharmaceutical company focused on the development of novel healthcare products. The Company develops and markets predictive medicine products, and is developing and intends to market therapeutic products. Myriad's news and other information are available on the Company's Web site at www.myriad.com.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to Myriad's provision of the genetic testing component of the pancreatic cancer clinical trial; the design of, the enrollment of patients in, and the successful completion of, the pancreatic cancer clinical trial; the ability of the pancreatic cancer clinical trial to confirm the showing of previous studies that a diagnostic test to determine the BRCA2 status of the pancreatic cancer patients may be indicated to determine the appropriate chemotherapy prior to initiating treatment in pancreatic cancer; the determination of the potential benefit of using mitomycin-C for people with BRCA2 gene mutations; the expectation of a substantial improvement in the six-month survival time of pancreatic cancer patients with a BRCA2 mutation using mitomycin-C over current survival rates from standard of care therapy; the belief that the pancreatic cancer clinical trial will provide validation for a novel personalized medicine product from Myriad; the exploration of the value of personalized drug therapy based on BRCA2 mutation status of a pancreas cancer patient; and the testing of pancreas cancer patients for BRCA2 mutations before instituting therapy based on the success of the clinical trial. These statements are based on management's current expectation and are subject to certain risks and uncertainties that could cause actual results to differ materially from those set forth or implied by forward-looking statements. These include, but are not limited to, uncertainties as to the extent of future government regulation of Myriad Genetics' business; uncertainties as to whether Myriad Genetics and its collaborators will be successful in developing, and obtaining regulatory approval for, and commercial acceptance of, therapeutic compounds; the risk that markets will not exist for therapeutic compounds that Myriad Genetics develops or if such markets exist, that Myriad Genetics will not be able to sell compounds, which it develops, at acceptable prices; and the risk that the Company will not be able to sustain revenue growth for its predictive medicine business and products. These and other risks are identified in the Company's filings with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the fiscal year ended June 30, 2006. All information in this press release is as of October 24, 2006, and Myriad undertakes no duty to update this information unless required by law.
Source: Myriad Genetics
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