Myriad Presents Additional Flurizan™ Phase 2 Study Data Demonstrating Benefit in Alzheimer's Patients
42% of Patients on Flurizan™ Had Improved or Not Declined After 24 Months
SALT LAKE CITY, UT, March 05, 2007—Myriad Genetics, Inc.
(NASDAQ: MYGN) (www.myriad.com) announced
today that it presented additional results of its completed Phase 2
follow-on study of Flurizan™ in patients with mild Alzheimer's
disease at the annual meeting of the American Association for
Geriatric Psychiatry (AAGP), held March 1-4, 2007 in New Orleans. The
data indicate that Flurizan may be capable, not only of slowing the
decline of Alzheimer's disease, but of halting the disease in its
tracks. In this study, many patients with Alzheimer's disease got no
worse over two full years, and in some cases, patients treated with
Flurizan appear to have improved.
At 24 months, study participants in the Phase 2 trial with mild
Alzheimer's disease taking 800 mg twice daily Flurizan experienced a
67% improvement in their level of cognitive decline compared with
placebo, as measured by the Mini Mental State Exam (MMSE) score. This
difference was highly significant statistically (p=0.001).
Additionally, based upon the MMSE score, three times the percentage
of patients on Flurizan demonstrated improvement in cognition or zero
decline, compared to patients on placebo: Forty-two percent of
patients on 800 mg twice daily Flurizan experienced improvement or
zero decline, compared with 14% of patients taking placebo. MMSE is
the primary test used by most clinicians to help diagnose, assess and
monitor progression of patients with Alzheimer's disease. It was also
the principal criterion for selecting patients to enroll in the Phase
2 study, and is a secondary endpoint in the two ongoing Phase 3
trials of Flurizan.
Overall, 42% of patients on Flurizan showed improvement or no decline
in one or more of the three primary endpoints of cognition, global
function and activities of daily living, compared to 10% of patients
on placebo. On the test that measures cognition, ADAS-cog, 25% of
study participants taking 800 mg BID of Flurizan showed cognitive
improvement or experienced zero decline in cognition after 24 months,
compared with none on placebo. With the CDR-sb test, a measure of
overall function in Alzheimer's patients, 29% of study participants
on Flurizan experienced an improved or zero decline score, compared
with none of those on placebo.
Robert C. Green, M.D., MPH, Co-Director, Alzheimer's Disease Clinical
& Research Program, Professor of Neurology, Genetics and Epidemiology
at the Boston University School of Medicine, and a lead investigator
on the Phase 3 trial of Flurizan, commented, "This analysis of
patient response to Flurizan in the Phase 2 trial suggests that the
drug may, in many patients, actually halt disease progression over a
24-month time frame. Since Flurizan appears to slow the biological
progression of the disease, this is an exciting and novel finding,
and if replicated in the ongoing Phase 3 trials will be
extraordinarily important."
To recap the efficacy results of the Phase 2 study at month 24
presented earlier, mild patients taking 800 mg of Flurizan twice daily
had an effect size of 72%, with a statistically significant value of
p=0.0005, as measured by their global function on the CDR-sb test. In
activities of daily living, the patients showed a statistically
significant 67% effect size (p=0.015). Cognition improvement showed
an effect size of 52% at 24 months on the ADAS-cog scale. These data
suggest that there is a substantial benefit from Flurizan.
The additional data presented at the AAGP meeting and announced today
add detail to these effect sizes by demonstrating that, not only did
the population as a whole respond to the treatment, but a meaningful
portion of the patients who responded to the treatment did so by
experiencing either zero decline after two years or a reversal of
their decline to actual improvement, something that is very rare in
Alzheimer's disease. Comparisons to placebo at 24 months refer to the
placebo group as originally randomized.
The vast majority of patients in this Phase 2 study, approximately
94% at the time of enrollment, were receiving stable doses of
acetylcholinesterase inhibitors, which are FDA-approved drugs for
symptomatic treatment of Alzheimer's disease. Thus, the benefits of
Flurizan observed in these patients were over and above the current
standard of care.
"The 24 month Phase 2 responder analysis provides further evidence of
efficacy against mild Alzheimer's disease that is consistent with our
understanding of Flurizan's mechanism of action as a SALA," said
Adrian Hobden, Ph.D., President of Myriad Pharmaceuticals, Inc. "The
results support our belief that Flurizan is modifying the course of
the underlying disease process."
About Flurizan
Myriad has two Phase 3 trials of Flurizan ongoing in patients with
mild Alzheimer's disease. In each study, participants are taking 800
mg of Flurizan or placebo twice daily, and the last participant
enrolled will have taken the study drug for 18 months. Flurizan is
the first in a new class of drug candidates known as Selective
Amyloid beta-42 Lowering Agents (SALAs). Flurizan lowered levels of
Abeta42 in cellular assays and animal models. Abeta42 is the primary
constituent of senile plaque that accumulates in the brain of
patients with Alzheimer's disease. It is thought to be the key
initiator of Alzheimer's disease, since Abeta42 has the greatest
tendency to aggregate, cause neuronal damage and initiate amyloid
deposits in the brain. Most genetic mutations that cause early-onset
Alzheimer's disease appear to do so by increasing production of
Abeta42. Myriad believes that Flurizan is the most advanced drug
candidate that modifies the production of Abeta42 to be evaluated in a
clinical trial for the treatment of Alzheimer's disease.
About Myriad
Myriad Genetics, Inc. is a biopharmaceutical company focused on the
development and marketing 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.
Flurizan is a trademark of Myriad Genetics, Inc. in the United States
and other countries.
This press release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements include: the capacity of Flurizan to not
only slow the decline of Alzheimer's disease, but halt the disease in
its tracks; the suggestion that patients on Flurizan with Alzheimer's
disease will get no worse, and in some cases reverse the course of the
disease, resulting in patient improvement; the showing of improvement
or no decline of patients on Flurizan on one or more of the three
primary endpoints of cognition, global function and activities of
daily living; the suggestion that Flurizan may, in many patients,
actually halt disease progression over a
24-month time frame; the
appearance that Flurizan slows the biological progression of the
disease, and the extraordinary importance of this finding if
replicated in the ongoing Phase 3 trials; the suggestion that there
is a substantial benefit from Flurizan; the demonstration that not
only did the population as a whole respond to the treatment, but a
meaningful portion of the patients who responded to the drug did so
by experiencing either zero decline after two years or a reversal of
their decline to actual improvement; the efficacy of Flurizan against
Alzheimer's disease consistent with the understanding of Flurizan's
mechanism of action as a SALA; the Company's belief that Flurizan is
modifying the course of the underlying disease process; the
appearance that Flurizan is modifying the underlying course of the
disease process; the continued encouragement of the Company by the
potential of Flurizan to treat mild Alzheimer's disease; the
anticipated completion of the Phase 3 trial, in order to confirm
similar efficacy results for Flurizan in a larger population; the
anticipated completion of enrollment of patients with mild
Alzheimer's disease in a global Phase 3 trial; and the belief that
Flurizan is the most advanced drug candidate in a clinical trial that
inhibits the production of Abeta42 to be evaluated in a clinical
trial for the treatment of Alzheimer's disease. 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 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 the date of this release, and Myriad
undertakes no duty to update this information unless required by law.
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