Myriad Genetics Phase 3 Trial in Alzheimer's Disease is Proceeding on Schedule
SALT LAKE CITY, Aug. 2 /PRNewswire-FirstCall/ -- Myriad Genetics, Inc.
(Nasdaq: MYGN), announced today that enrollment in its Phase 3 trial of
Flurizan™ in patients with mild stages of Alzheimer's disease is proceeding on
schedule. The Company's amended protocol was reviewed by the FDA without any
changes or request for modification and the central Investigational Review
Board covering a majority of the investigational sites has given its approval
of the modified protocol. More than 120 sites across the United States have
been enlisted and most are now screening and enrolling patients into the
study. Myriad anticipates completing enrollment for the 12-month study during
the first half of 2006 and reporting the results of the Phase 3 trial in the
third calendar quarter of 2007.
Myriad used the results of its Phase 2 trial of Flurizan™, which were
presented at the Alzheimer's Association International Conference on
Prevention of Dementia in June, to fine tune its Phase 3 trial. The Phase 2
study indicated that patients with mild Alzheimer's disease treated with
800 mg Flurizan™ twice daily, experienced the greatest benefit, with a 34%
slowing in the rate of cognitive decline. This finding also guided Myriad to
size the study to show statistical significance given a 30% improvement versus
placebo with 90% confidence.
"We believe that the Phase 3 trial of Flurizan™ in Alzheimer's disease is
well-powered to convincingly demonstrate the impressive therapeutic effect
that was seen in mild Alzheimer's disease in the Phase 2 trial," said Adrian
Hobden, Ph.D., President of Myriad Pharmaceuticals, Inc. "By concentrating on
the mild population, using the higher 800 mg dose, and maintaining consistency
among most of the other study variables, we believe we have paved the way for
a successful trial."
Myriad 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. These
forward-looking statements include: continued enrollment in the Company's
Phase 3 trial of Flurizan™ in patients with mild stages of Alzheimer's disease
proceeding on schedule; subsequent reviews or comments by the FDA or central
Investigational Review Board regarding the protocol for the Phase 3 trial; the
number of sites screening and enrolling patients in the study; anticipating
completing enrollment for the 12-month study during the first half of 2006;
reporting results of the Phase 3 trial in the third calendar quarter of 2007;
the powering of the Phase 3 trial to convincingly demonstrate therapeutic
effect; and the anticipated success of the Phase 3 trial. These
forward-looking 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, 2004. All information in this
press release is as of August 2, 2005, and Myriad undertakes no duty to update
this information unless required by law.
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