Myriad Genetics Sponsors Clinical Trial in Pancreatic Cancer
Study May Lead to New Personalized Medicine Product
Salt Lake City, October, 24, 2006—Myriad Genetics, Inc.
(Nasdaq: MYGN) (www.myriad.c
om), 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.
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