Myriad Genetics Presents Phase I Results at International Conference on Alzheimer's Disease
Flurizan Safe and Well Tolerated in Healthy Older Volunteer Study
SALT LAKE CITY, July 20 /PRNewswire-FirstCall/ -- Myriad Genetics, Inc.
(Nasdaq: MYGN), presented new clinical trial data on its investigational
Alzheimer's disease drug candidate, Flurizan™ (R-flurbiprofen, MPC-7869), at
the Ninth International Conference on Alzheimer's Disease and Related
Disorders in Philadelphia, PA [Poster session P2, July 19, 2004,
12:30 - 2:45pm].
Dr. Edward H. Koo, M.D., Professor of Neurosciences at the University of
California, San Diego presented results from a study of the safety and
tolerability following 21-day administration of Flurizan in healthy elderly
volunteers. The results were drawn from Myriad's Phase I randomized,
double-blinded, placebo-controlled trial of Flurizan. The trial enrolled
48 people between the ages of 55 and 80 years, in four cohorts, which were
studied over a three-week course of daily dosing with Flurizan. The first
cohort was given 400mg daily, the second cohort 800mg, the third 1600mg and
the fourth, a placebo. Dr. Koo reported that no serious adverse events were
observed in any of the cohorts. These data complement the safety record
established with Flurizan to date in three other completed trials among
healthy individuals and patients.
In this trial designed to evaluate the safety of Flurizan, there were not
only no serious adverse events, there were no dropouts from the trial due to
any adverse event. The number and nature of adverse events collected was not
significantly different between the treated groups or those on placebo.
Specifically, no difference was observed between any of the groups in reports
of adverse gastrointestinal events.
"We are very pleased that the results of this trial in older volunteers
mirrors our experience with Flurizan in other human clinical trial settings,
providing further evidence that Flurizan is safe and well-tolerated," said
Adrian Hobden, Ph.D., President of Myriad Pharmaceuticals, Inc. "The safety
profile appears well-suited to use with an Alzheimer's disease population."
Summary of Trial Results
Flurizan (R-flurbiprofen, MPC-7869) was safe and well tolerated in healthy
older volunteers when administered in doses of up to 1600 mg/day for 21 days.
Current Development Status of Flurizan
Further to the trial discussed today, Myriad's drug candidate, Flurizan,
is being investigated in a randomized, double-blinded, placebo-controlled,
three arm Phase II trial to assess efficacy among approximately 200 patients
with mild to moderate Alzheimer's disease in the United Kingdom and Canada.
This trial is scheduled to complete its one-year term of study in the first
calendar quarter of 2005.
Flurizan is not a Cyclooxygenase (COX) Inhibitor
Historically, chronic users of certain non-steroidal anti-inflammatory
drugs (NSAIDs) have a reduced risk of Alzheimer's disease. However, long-term
use of NSAIDs, especially at higher doses, are limited by the occurrence of
NSAID-induced ulcers. Regular use of NSAIDs is the second leading cause for
ulcers, resulting in over 100,000 hospitalizations and approximately
16,500 deaths annually in the U.S. from ulcer-related complications, according
to studies published in the New England Journal of Medicine and the Journal of
the American Medical Association.
NSAIDs inhibit the COX enzyme. In contrast, by isolating the R-enantiomer
from its mirror twin S-enantiomer, Flurizan retains the amyloid lowering
ability that is a property of a subset of these drugs without their
accompanying COX inhibition and related ulcer-causing effects. To date,
studies suggest that Flurizan may treat Alzheimer's disease without causing
ulcers and other side effects.
This study was funded in part by NIH grant AG20206 to Edward H. Koo, M.D.
About Myriad
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 relating to the safety profile of Flurizan and its suitability for
treatment of Alzheimer's disease and the expected completion of a Phase II
trial for Flurizan in the first calendar quarter of 2005. 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, 2003. All information in this
press release is as of July 20, 2004, and Myriad undertakes no duty to update
this information unless required by law.
SOURCE Myriad Genetics, Inc.
CONTACT: William A. Hockett, Vice President of Corporate Communications,
+1-801-584-3600, bhockett@myriad.com
Web site: http://www.myriad.com
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