Myriad Genetics Submits IND in Alzheimer's Disease to FDA
SALT LAKE CITY, Aug 22, 2002 /PRNewswire-FirstCall via COMTEX/ -- Myriad
Genetics, Inc. (Nasdaq: MYGN) has submitted an Investigational New Drug (IND)
application for the evaluation of its drug, R-flurbiprofen, for the treatment
and prevention of Alzheimer's disease, the Company announced today. In the
submitted Phase I trial, Myriad will establish the safety profile and dosing
regimens of R-flurbiprofen in healthy elderly volunteers. The trial's principal
investigators are Alzheimer's disease experts Drs. Todd Golde and Neill
Graff-Radford of Mayo Clinic Jacksonville (Florida) and Drs. Edward Koo and Doug
Galasko of the University of California San Diego. The study is designed to
enroll 48 subjects and to be completed within 12 months, inclusive of
enrollment, and is co-sponsored by the National Institute on Aging under a grant
to Dr. Edward Koo at UCSD. Myriad holds an issued United States Patent and has
several patent applications pending on the use of R-flurbiprofen in the
prevention and treatment of Alzheimer's disease.
Alzheimer's disease is a degenerative neurological condition affecting up to 20%
of all people aged 80 or older, with an estimated 4 million cases in the United
States alone. Current approved treatments, such as acetylcholinesterase
inhibitors, temporarily mitigate symptoms without meaningfully impacting
progression of the underlying disease. Alzheimer's disease is marked by
progressive cognitive decline and by the accumulation of amyloid plaques and
neurofibrillary tangles in the brain. The major structural component of these
plaques is amyloid beta protein, specifically Amyloid beta-42 (Ab42). Many
researchers now believe that Ab42 plays an important role in the onset of
Alzheimer's disease. Current research is focused on compounds that decrease
levels of Ab42 with the hope of preventing or slowing the progression of
Alzheimer's disease.
According to Dr. Golde, "The ability to lower Ab42 levels is a key measure that
is likely to be associated with reduction in the risk of developing Alzheimer's
disease. It is also possible that lowering Ab42 could be of benefit in patients
who have clinical Alzheimer's disease. Of all the compounds in this class that
are available for timely administration to humans, R-flurbiprofen demonstrates
the greatest potential to lower Ab42 while apparently maintaining an excellent
safety profile."
An epidemiological study of 7,983 patients, conducted by Dr. Bruno H.C. Stricker
and colleagues of Erasmus Medical Center, Rotterdam, Netherlands, indicated that
long-term use of certain nonsteroidal anti-inflammatory drugs (NSAIDs) could
reduce the likelihood of developing Alzheimer's disease by 80% (N Engl J Med,
345, 1515-1521, 2001). As reported at the 8th International Conference on
Alzheimer's Disease and Related Disorders in July 2002, further analysis of the
Rotterdam study revealed that decreased risk of Alzheimer's disease appeared to
correspond only with those NSAIDs which lowered the production of Ab42.
Preclinical studies performed with NIH funding, at Mayo Clinic Jacksonville and
UCSD have demonstrated that R-flurbiprofen substantially lowers the levels of
Ab42 in both human cell lines and in animal models of Alzheimer's disease. These
results further indicated that R-flurbiprofen lowers Ab42 more dramatically than
NSAIDs.
"Extended use of NSAIDs is associated with potentially severe gastrointestinal
side effects, such as gastric ulcers and severe stomach bleeding, which reduce
their clinical utility for chronic conditions such as Alzheimer's disease," said
Adrian Hobden, Ph.D., President of Myriad Pharmaceuticals, Inc. "In contrast,
R-flurbiprofen has demonstrated exceptional gastrointestinal safety in prior
studies in man."
Additional in vitro research conducted by Dr. Greg Cole and colleagues at the
University of California Los Angeles (UCLA), and presented at the 8th
International Conference on Alzheimer's Disease and Related Disorders, further
support the potential clinical utility of R-flurbiprofen. The study found that
R-flurbiprofen limited production of Ab42 and also of two other proteins
implicated in the formation of plaques. Of the drugs tested, Dr. Cole
specifically singled out R-flurbiprofen concluding that, "Because of this triple
efficacy and low side-effect profile, R-flurbiprofen shows potential for
clinical trials aimed at Alzheimer's disease prevention or treatment."
Upon successful completion of Myriad's Phase I study, Myriad plans to initiate a
subsequent Phase II human clinical trial to evaluate the ability of
R-flurbiprofen to prevent cognitive decline in patients suffering from either
early Alzheimer's disease or mild cognitive impairment (MCI), a less severe
disease that primarily affects memory. Sixty percent of patients with MCI
progress to Alzheimer's disease within five years of diagnosis. Additional
ongoing studies are evaluating the impact of long-term administration of
R-flurbiprofen on cognitive impairment in a mouse model of Alzheimer's disease.
Myriad Genetics, Inc. is a leading biopharmaceutical company focused on the
development of novel healthcare products. The Company develops and intends to
market therapeutic products in multiple therapeutic areas such as cancer and
viral diseases. Myriad has introduced five proprietary predictive medicine and
personalized medicine products to the market. The Company has established
strategic alliances with Abbott, Bayer, Eli Lilly, Dupont, Hitachi, Novartis,
Oracle, Pharmacia, Roche, Schering AG, Schering-Plough, LabCorp, and Syngenta.
Further information is available online at www.myriad.com .
The discussion in this news release includes forward-looking statements that are
subject to certain risks and uncertainties, including statements relating to the
likelihood of success of the Company's clinical trials and the potential of
R-flurbiprofen to lower the levels of Ab42. Such statements are based on
management's current expectations that are subject to risks and uncertainties
that could cause actual results to differ materially from those set forth or
implied by forward-looking statements, including, but 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, therapeutics; 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. 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, 2001.
All information in this press release is as of August 22, 2002, 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
of Myriad Genetics, Inc., +1-801-584-3600, bhockett@myriad.com
URL: http://www.myriad.com
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