Myriad Genetics Announces Completion of Phase 1 Trial of Anti-Thrombin Drug MPC-0920
Drug Candidate Has Dose-Dependent Effect on Clotting Time and Appears Well-Tolerated
Salt Lake City, UT, Jan 29, 2008—Myriad Genetics, Inc. (NASDAQ: MYGN) has completed a Phase 1 human
clinical trial of MPC-0920, an orally available, direct thrombin
inhibitor. The trial studied healthy volunteers in a single,
escalating dose format, to determine the safety, dose range and
pharmacokinetics of the drug candidate. The results demonstrate
significant biological effect on clotting time and a desirable safety
profile following oral administration.
MPC-0920 is designed to address the pressing medical needs for rapid
and predictable anticoagulant action, an improved therapeutic window,
predictable patient response and increased efficacy. The Phase 1
trial was administered in a single ascending dose format, in which
there were eight volunteers per cohort, six of whom are given the
drug and two are given placebo. MPC-0920 was shown to be absorbed
with a very close correlation between the plasma concentration of
drug in plasma and an effect on blood clotting as measured by an
increase in pro-thrombin time. There were no apparent drug related
adverse events during the study. The primary objectives of the Phase
1 trial were to examine the safety and pharmacokinetics of MPC-0920
and a secondary objective was to study the biological activity of
MPC-0920. Unlike most Phase 1 studies, this study showed that a
significant biological activity was present and highly correlated to
the observed plasma concentration.
In addition to the completed Phase 1 human clinical trial, MPC-0920
has been the subject of 27 preclinical studies to date, comprising
safety, toxicity, pharmacokinetics and formulation. MPC-0920 is
covered by four issued patents, two U.S. and two foreign.
“We are pleased to report Phase 1 safety data for MPC-0920 and to
have demonstrated an effect on clotting time in human volunteers,”
said Adrian Hobden, Ph.D., President of Myriad Pharmaceuticals, Inc.
“Thrombosis is a serious problem and we believe MPC-0920 has the
potential to become a significant option in anti-thrombotic therapy.”
Myriad intends to aggressively seek a commercial partner for MPC-0920
rather than pursuing further regulatory development independently.
The Company‘s drug development focus remains on its core areas of
neurodegeneration, cancer and anti-virals.
The market to treat thrombosis is large, totaling over $6.5 billion
in the United States last year, and there is an urgent need for
improved drugs, particularly those that can be taken orally.
Thrombosis, the formation of a clot within a blood vessel, is one of
the most common causes of death in the Western World. Approximately
two million individuals in the United States die each year from an
arterial or venous thrombosis or its consequences. In addition,
thrombosis results in significant morbidity, particularly in the
elderly. The most common form of thrombosis is deep-vein thrombosis
(DVT) in the leg. This type of clot can break apart, travel up the
leg and through the heart, lodging in the lungs and causing blockage
of an artery. Known as pulmonary embolism, this condition causes lung
tissue death and is an often-fatal complication of DVT. Major
indications for MPC-0920 in anti-thrombosis include DVT, atrial
fibrillation, artificial heart valves and in major open surgery such
as hip replacement, which is increasingly common in older patients.
The drugs currently used to treat this condition are the
anticoagulants heparin and warfarin (tradename: Coumadin®). These
drugs are widely used. One-third of hospitalized patients in the
United States, approximately 12 million in total, receive heparin.
However, both drugs have major drawbacks. Heparin requires
intravenous administration and blood-level monitoring.
Heparin-induced thrombocytopenia–low platelet count–is a common
serious drug reaction in hospitals. Warfarin is the only orally
available anti-thrombotic currently approved for use in the U.S. The
use of warfarin is complicated by the fact that it has serious
interactions with many commonly used drugs, causing unwanted side
effects. It also interacts with compounds found in food. Warfarin can
be highly toxic and has a very narrow therapeutic window. Because of
the risk of serious side effects, patients are typically monitored
twice weekly when they are first put on warfarin. Accordingly, there
is a large and urgent unmet medical need for new therapies.
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.
This press release contains “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements include statements relating to the
demonstrated results of good oral bioavailability, biological effect
on clotting time and desirable safety profile; the design and ability
of MPC-0920 to address the pressing medical needs for rapid and
predictable anticoagulant action, improved therapeutic window,
predictable patient response and increased efficacy; the ability of
MPC-0290 to be orally available with a very close correlation between
the concentration of drug in plasma and an effect on blood clotting
as measured by an increase in pro-thrombin time; the Company's belief
that MPC-0290 has the potential to become a significant option in
anti-thrombin therapy; and the Company's intent to seek a commercial
partner for MPC-0920 rather than pursuing further regulatory
development independently. These risks and uncertainties include,
but are not limited to, the success of MPC-0920 in subsequent
clinical trials in demonstrating good oral bioavailability, a
biological effect on clotting time and a desirable safety profile;
our inability to further identify, develop and achieve commercial
success for new products and technologies; our ability to discover
drugs that are safer and more efficacious than our competitors; our
ability to develop molecular diagnostic products that help assess
which patients are subject to greater risk of developing diseases and
who would therefore benefit from new preventive therapies; the
possibility of delays in the research and development necessary to
select drug development candidates and delays in clinical trials; the
risk that clinical trials may not result in marketable products; the
risk that we may be unable to successfully finance and secure
regulatory approval of and market our drug candidates, or that
clinical trials will be completed on the timelines we have estimated;
uncertainties about our ability to obtain new corporate
collaborations and acquire new technologies on satisfactory terms, if
at all; the development of competing products and services; our
ability to protect our proprietary technologies; patent-infringement
claims; risks of new, changing and competitive technologies and
regulations in the United States and internationally; and other
factors discussed under the heading “Risk Factors” contained in Item
1A in our Annual Report on Form 10-K for the year ended June 30,
2007, 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 the release, and Myriad undertakes no duty to update this
information unless required by law.
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