Myriad Genetics' Follow-on Study of Flurizan™ Demonstrates Continued Effect in Alzheimer's Disease
Phase 3 Study of Flurizan™ Enrolling on Schedule
SALT LAKE CITY, September 22, 2005 -- Myriad Genetics, Inc.
(Nasdaq: MYGN) announced today that an analysis of data from a Phase 2
follow-on study in patients with mild Alzheimer's disease was presented today
at the Congress of the International Psychogeriatric Association in Stockholm,
Sweden. The data showed that study participants with mild Alzheimer's disease
who received 800 mg of Flurizan twice daily, appeared to stabilize and
experience no further decline in cognitive function from months twelve to
fifteen, as measured by the ADAS-cog (Alzheimer's Disease Assessment Scale,
cognitive subscale) test. Results of the 3-month follow-on data were
presented by the study's principal investigator, Gordon Wilcock, M.D., of the
University of Bristol, UK.
After completion of Myriad's 12-month Phase 2 trial of Flurizan, study
participants in Canada were given the option to continue in a follow-on study.
A total of 81% of those participants opted to join the follow-on study. Those
participants who had previously received placebo during the Phase 2 trial were
randomized into the 400 mg BID group or the 800 mg BID group. Participants
who were taking Flurizan in the initial Phase 2 trial continued on the same
dose that they had been receiving.
The 3-month follow-on results showed that patients taking 800 mg of
Flurizan twice daily appeared to retain their cognitive ability during the
follow-on period, and did not decline further during months twelve to fifteen.
Specifically, at month twelve, the 800 mg BID dose group had declined an
average of 2.8 points on the ADAS-cog scale since the beginning of the trial.
After the three additional months on Flurizan, these patients had an average
ADAS-cog decline of 2.7 points, an improvement of 0.1 point. These data
indicate that patients did not decline further during this follow-on study and
in fact demonstrated a small improvement. In the global measure of Alzheimer's
disease, CDR-sb (Clinical Dementia Rating -- Sum of Boxes), patients in the
800 mg BID dose group ended twelve months on Flurizan with a 1.3 point decline
and after fifteen months the total decline was 1.4 points. This 0.1 point
change, equivalent to 0.03 points per month change during the follow-on three
months, represents a slowing in rate of decline compared with an average loss
of 0.11 points per month from months one to twelve. In the functional measure,
ADCS-ADL (Alzheimer's Disease Cooperative Study -- Activities of Daily
Living), patients in the 800 mg BID group maintained a more than 3 point
margin of improvement compared with the placebo rate of decline for ADCS-ADL,
extrapolated from twelve to fifteen months.
The Company believes that the positive response in cognitive stabilization
in the 800 mg BID dose group is not attributable to a placebo effect. Study
participants do not know whether they received drug or placebo during the
first twelve months, and do not know what dose of Flurizan they are receiving
in the follow-on portion of the study. Investigators are equally blinded in
this aspect of the follow-on study.
"We continue to be encouraged by the potential of Flurizan to treat mild
Alzheimer's disease," said Adrian Hobden, Ph.D., President of Myriad
Pharmaceuticals, Inc. "The follow-on data show that patients with mild
Alzheimer's disease, treated with 800 mg BID of Flurizan, appear not only to
have a slowing in loss of cognition as we saw in the Phase 2 study, but may
have stopped declining in cognitive ability altogether. We look forward to
completing enrollment in the Phase 3 trial in order to confirm these results
in a larger patient population."
Based on the positive Phase 2 results, Myriad is enrolling patients with
mild Alzheimer's disease in its Phase 3 trial, at 130 sites across the United
States. This enrollment is proceeding on schedule. The Phase 3 trial is a
double blind, placebo-controlled trial. Patients will be randomized into one
of two treatment arms, receiving either 800mg of Flurizan or placebo twice
daily for the duration of the 12-month trial period. The study is designed to
determine Flurizan's ability to alter the course of cognitive decline and
functional change in patients with mild Alzheimer's disease, as measured by
the ADAS-cog test and the change in ADCS-ADL, respectively. Information on
participation is available by calling (800) 649-7316 or emailing
clinicaltrials@myriad.com.
About Flurizan™
Flurizan is the first candidate in a new class of drugs known as selective amyloid beta lowering agents (SALAs).
Flurizan lowered levels of Abeta42 in
cellular assays and animal models. Abeta42 is the primary constituent of
senile plaques that accumulate in the brains 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 first well-tolerated drug that
inhibits 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 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.
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 appearance of study participants with
mild Alzheimer's disease who received 800 mg of Flurizan twice daily to
stabilize and experience no further decline in cognitive function and to
retain their cognitive ability during the follow-on period as measured by the
ADAS-cog test; the indication that patients did not decline further during
this follow-on study and in fact demonstrated a small improvement; the
indication of a slowing in rate of decline under the CDR-sb global measure of
Alzheimer's disease; the indication of a more than 3 point margin of
improvement compared with placebo rate of decline for ADCS-ADL, extrapolated
from twelve to fifteen months; the Company's belief that the positive response
in cognitive stabilization in the 800 mg BID dose group is not attributable to
placebo effect; the continued encouragement of the Company by the potential of
Flurizan to treat mild Alzheimer's disease; the anticipated completion of
enrollment in the Phase 3 trial in order to confirm similar efficacy results
for Flurizan in a larger population; the continued, on schedule, enrollment of
patients with mild Alzheimer's disease in the Company's Phase 3 trial at 130
US sites; the design of the Phase 3 study, and the ability of the Phase 3
study, to successfully determine Flurizan's ability to alter the course of
cognitive decline and functional change in patients with mild Alzheimer's
disease as measured by the ADAS-cog test, and the change in ADCS-ADL,
respectively. 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, 2005. All
information in this press release is as of September 22, 2005, and Myriad
undertakes no duty to update this information unless required by law.
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