Myriad Genetics Announces Results of Phase 2 Prostate Cancer Trial
SALT LAKE CITY, January 8, 2007—Myriad Genetics, Inc.
(NASDAQ: MYGN)
announced today the results of
its multi-center, double-blind, placebo-controlled human clinical
trial of MPC-7869 (R-flurbiprofen) in prostate cancer. The clinical
trial was designed to evaluate the safety of MPC-7869 and to consider
its potential efficacy in slowing the rate of progression of prostate
cancer among 246 patients with advanced disease.
Patients participating in the study were assigned to one of three
arms (800 mg once daily or 800 mg twice daily of MPC-7869 or
placebo). The two primary clinical endpoints of the trial were the
time to systemic disease progression and the change in velocity of
Prostate Specific Antigen levels. Statistical significance was not
achieved for either of the endpoints, and therefore the Company does
not intend to pursue further development of this compound in cancer.
Myriad will continue to concentrate its efforts on the compound's
demonstrated activity in Alzheimer's disease.
The study showed that MPC-7869 was well tolerated over long-term
administration in an elderly population, confirming the data from
previous studies. With the completion of this study, Myriad now has
over 1,200 patient-years of safety data on this compound, with a
maximum exposure period of 44 months.
The study showed no significant differences in adverse events between
the placebo and drug-treated arms. Additionally, during the course of
the study, there were no significant differences in serious adverse
events between the drug and placebo arms. Twenty-two patients
experienced serious adverse events in the placebo group, compared to
22 in the 800 mg once daily group and 23 in the 800 mg twice daily
group. In particular, there were no significant differences between
the drug-treated and placebo groups for adverse gastrointestinal,
myocardial or cerebrovascular events.
"The safety data collected in this trial will be very useful to our
program in Alzheimer's disease," said Peter Meldrum, President of
Myriad Genetics, Inc. "The age of the study population is similar and
the 800 mg twice daily dose of MPC-7869 is identical to that of our
two ongoing Phase 3 trials in Alzheimer's disease."
Myriad Genetics, Inc. is a biopharmaceutical company focused on the
development of novel healthcare products. The Company develops and
markets molecular diagnostic 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 relating to the concentration of the Company's
efforts on MPC-7869's demonstrated activity in Alzheimer's disease;
the utility of the safety data collected in the Phase 2 trial to the
Company's program in Alzheimer's disease; the tolerability of
MPC-7869 in long-term administration in an elderly population; and
the statistical significance of adverse and serious adverse events in
studies of MPC-7869, including gastrointestinal, myocardial or
cerebrovascular events. These forward looking statements are based on
management's current expectations 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 risks and uncertainties include, but are not
limited to, our inability to further identify, develop and achieve
commercial success for new products and technologies; our ability to
discover drugs that are safer and more efficacious than our
competitors; our ability to develop molecular diagnostic products
that help assess which patients are subject to greater risk of
developing diseases and who would therefore benefit from new
preventive therapies; the possibility of delays in the research and
development necessary to select drug development candidates and
delays in clinical trials; the risk that clinical trials may not
result in marketable products; the risk that we may be unable to
successfully finance and secure regulatory approval of and market our
drug candidates, or that clinical trials will be completed on the
timelines we have estimated; 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; our ability to protect our proprietary technologies;
patent-infringement claims; 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, 2006, 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 January 8, 2007, and Myriad undertakes no duty to
update this information unless required by law.
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