Myriad Genetics Presents Mathematical Comparison of Disease Modification Trial Designs at Alzheimer's Conference
Current Flurizan™ Phase 3 Study Design May Demonstrate Disease Modification
Salt Lake City, UT, Jun 11, 2007—Myriad Genetics, Inc. (NASDAQ: MYGN) (www.myriad.com) announced
today that it presented a mathematical comparison of a "Staggered
Start" and a "Randomized Withdrawal" clinical trial design with a
"Natural History Staggered Start" clinical trial design at the
Alzheimer's Association Prevention Conference held June 9 - 12, 2007,
in Washington, D.C. The analysis demonstrates that the "Natural
History Staggered Start" trial design currently being used in the
Flurizan Phase 3 study can provide the same level of disease
modification support as the cross-over trial designs, which are
challenged by ethical concerns, dropout bias and complications.
A disease modifying therapy for Alzheimer's disease (AD) is one that
has an impact on the underlying pathology of the disease and thus
slows the rate of a patient's decline over the course of long-term
treatment. In contrast, the currently available AD medicines are
believed to treat the symptoms of AD without impacting the underlying
disease process or providing long lasting benefit. The development
of robust methods to demonstrate disease modification in AD clinical
trials has been a controversial issue in the field, and to date,
there have been no studies that provide convincing evidence of
disease modification in AD. Two clinical trial designs that could
provide evidence for disease modification were originally proposed
for AD studies over 10 years ago by Paul Leber, then the head of the
Division of Neuropharmacological Drug Products of the FDA. These
designs have come to be known as the "Randomized Withdrawal" and
"Staggered Start" designs and are based on measuring clinical
outcomes in a cross-over type study.
In the randomized withdrawal design, patients are withdrawn from
therapy after a defined period to determine whether the long-lasting
benefit to the patient is maintained, demonstrating disease
modification, or if the patient drops back to the level of patients
on placebo for the duration of the study. In a staggered start
design, one group of patients receives the active study drug for the
entire study period, while a second group initially receives placebo
and then later is given the active drug. If the second group fails
to "catch up" in the level of performance of the first group, this is
taken to be evidence for a disease modifying effect of the drug.
Unfortunately, these designs are difficult to implement and have
rarely been used in clinical trials as they are complicated by very
long study durations, leading to high dropout rates that introduce
biased results, as well as presenting ethical concerns unacceptable to
patients and their families.
A team of biostatisticians and mathematicians at Myriad, led by
Suzanne Hendrix, Ph.D., Sasha Gutin, Ph.D., and Scott Horton, has
proposed an alternative strategy designated the "Natural History
Staggered Start" analysis, that compares the slopes of decline of
drug treated patients with those of patients receiving placebo and
corrects for the severity of disease at baseline. The mathematical
analysis presented at the Alzheimer's Association AD Prevention
Conference demonstrates that this trial analysis methodology is
mathematically equivalent to the "Staggered Start" and "Randomized
Withdrawal" designs and provides the same level of evidence of a
disease-modifying drug effect in a clinical trial that is not subject
to the above-mentioned complications, bias and ethical challenges of
the previous designs.
"We are excited about this persuasive mathematical comparison of
clinical trial designs," said Adrian Hobden, PhD, President of Myriad
Pharmaceuticals, Inc. "We believe that this mathematical proof,
coupled with the Flurizan trial design may strengthen the Company's
position with the FDA in favor of a disease modification label for
Flurizan."
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 participants 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 whether the Flurizan Phase 3 study
design may demonstrate disease modification; the Company's use of the
Natural History Staggered Start trial design and trial analysis
methodology in its Flurizan Phase 3 clinical trials; the ability of
the Natural History Staggered Start trial design and trial analysis
methodology to provide the same level of disease modification support
as the cross-over trial designs; the ability of the Natural History
Staggered Start trial design and trial analysis methodology to
demonstrate that this trial analysis methodology is mathematically
equivalent to the "Staggered Start" and "Randomized Withdrawal"
designs and provides the same level of evidence of a disease
modifying drug effect in a clinical trial that is not subject to the
complications, bias and ethical challenges of previous designs; the
excitement of the Company about this persuasive mathematical
comparison of clinical trial designs and the Company's belief that
this mathematical proof, coupled with the Flurizan trial design, may
strengthen the Company's position with the FDA in favor of a disease
modification label for Flurizan; the successful completion of the
ongoing Flurizan Phase 3 trials; and whether the Flurizan Phase 3
trials results will demonstrate or support a claim of disease
modification. 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.
Contact:
William A. Hockett
EVP, Corporate Communications
(801) 584-3600
Email: http://www2.marketwire.com/mw/emailprcntct?id=0EBF31563AECA7D4
|
