Myriad Genetics Initiates Enrollment in Phase II Alzheimer's Drug Trial
- Regulatory Approvals Received From the United Kingdom and Canada -
SALT LAKE CITY, June 25 /PRNewswire-FirstCall/ --
Myriad Genetics, Inc. (Nasdaq: MYGN), has opened enrollment for patients in
its Phase II trial of its drug, MPC-7869 (R-flurbiprofen), in the treatment of
mild to moderate Alzheimer's disease. The trial is being conducted
simultaneously in approximately 30 centers in the United Kingdom and Canada.
In May 2003, Myriad submitted the UK regulatory filing known as a Clinical
Trial Exemption (CTX) and its Canadian equivalent, the Clinical Trial
Application (CTA), and recently received regulatory approvals for the trial in
both countries to proceed with patient enrollment.
The Phase II trial is designed to study the efficacy of MPC-7869 in
altering the progression of Alzheimer's disease. It is a multi-center,
randomized, double-blind, placebo-controlled, 12-month study with three arms,
involving approximately 200 patients with mild to moderate Alzheimer's
disease. The lead investigator of the trial is Professor Gordon K. Wilcock,
D.M.(Oxon), FRCP, of the University of Bristol in the United Kingdom. Dr.
Wilcock is Professor in Care of the Elderly and a leading expert in
Alzheimer's disease.
The primary outcome measure of the study is the one-year change in the
Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-cog) score and
the Clinical Dementia Rating - Sum of Boxes (CDR-sb) score. Secondary
measures will assess changes in activities of daily living, behavior and
global function.
Professor Wilcock commented, "Because current drugs provide only
symptomatic relief of Alzheimer's disease, and do not alter the progression of
the underlying disease, there is still an enormous need for drugs that can
control progression of this debilitating condition. The unique properties of
MPC-7869, as revealed in preclinical studies, suggest that this
investigational drug may be able to slow progression of Alzheimer's disease.
I look forward to participating in this trial."
"We are very pleased to have the Phase II trial of our Alzheimer's drug
underway and in the capable hands of world-leading Alzheimer's disease
researchers," said Peter Meldrum, President of Myriad Genetics, Inc. "Myriad
has focused substantial resources on the development of its clinical programs
including Alzheimer's disease. We are committed to advancing our preclinical
pipeline of drug candidates including those addressing cancer and AIDS into
human clinical trials."
Abeta42, Amyloid Plaques and Alzheimer's Disease
Abeta42 is the abbreviation for Beta-amyloid peptide consisting of
42 amino acids. Abeta42 is the primary constituent of the 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 this peptide 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.
These findings have led to intense research efforts to develop drugs that
inhibit production of Abeta42. The investigational drug MPC-7869 has been
shown to be effective in lowering levels of Abeta42 in cellular assays and
animal models. Myriad believes that MPC-7869 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 Alzheimer's Disease
Alzheimer's disease is the most common form of dementia, and is
characterized by the loss of mental function. The disease affects 4.8 million
individuals in the United States alone, and over 25 million people worldwide.
Twenty-five percent of the population over age 75 is affected. Common
symptoms include a gradual loss of memory, problems with reasoning or
judgment, disorientation, difficulty in learning, loss of language skills, and
decline in the ability to perform routine tasks. The areas of the brain that
control memory and thinking skills are affected first, but as the disease
progresses, cells die in other regions of the brain. Eventually, the person
with Alzheimer's disease will need comprehensive nursing care. If the
individual has no other serious illness, the loss of brain function itself
will eventually cause death. There is a very large unmet need for treatments
that arrest cognitive decline and may prevent Alzheimer's disease. The most
commonly prescribed drugs to treat the symptoms of Alzheimer's disease are
acetylcholinesterase inhibitors. These drugs provide a temporary increase in
cognitive ability to patients but the course of the underlying disease is left
unchanged and cognitive decline soon continues. The United States market for
acetylcholinesterase inhibitors is estimated at $1.2 Billion per year.
About Myriad Genetics, Inc.
Myriad Genetics, Inc. is a leading biopharmaceutical company focused on
the development of novel healthcare products. The Company develops and
markets proprietary predictive medicine and personalized medicine products,
and is developing and intends to market a number of promising therapeutic
products that address large potential markets. 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. These
forward looking statements, including statements relating to the course of
development and potential efficacy of MPC-7869 and the Company's intention to
develop and market other drugs including those addressing cancer and AIDS, 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 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, 2002. All
information in this press release is as of June 25, 2003, and Myriad
undertakes no duty to update this information unless required by law.
SOURCE Myriad Genetics, Inc.
-0- 06/25/2003
/CONTACT: William A. Hockett, Vice President of Corporate Communications
of Myriad Genetics, Inc., +1-801-584-3600, bhockett@myriad.com /
/Web site: http://www.myriad.com /
(MYGN)
CO: Myriad Genetics, Inc.; University of Bristol
ST: Utah, Canada, England
IN: MTC BIO HEA EDU
SU:
EC
-- LAW026 --
7224 06/25/2003 06:30 EDT http://www.prnewswire.com
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