DENVER, July 15 /PRNewswire-FirstCall/ -- Myogen, Inc. (Nasdaq: MYOG), a
biopharmaceutical company focused on the discovery, development and
commercialization of small molecule therapeutics for the treatment of
cardiovascular disorders, today announced the initiation of a Phase IIb
clinical trial to evaluate the safety and efficacy of darusentan in patients
with resistant systolic hypertension.
"Recent clinical studies suggest that, despite the availability and use of
multiple drugs, a considerable number of patients with hypertension remain at
risk for progressive cardiovascular and renal complications due primarily to
inadequately controlled blood pressure," said J. William Freytag, Ph.D.,
President and Chief Executive Officer of Myogen. "The results of these
studies lead us to believe that there is a need for new antihypertensive
drugs, with unique mechanisms of action compared to existing approved
therapies, that can act additively with currently available antihypertensive
drugs to lower blood pressure in patients with resistant hypertension. We
believe the initiation of this clinical trial represents a significant step in
both the development of darusentan as a potential add-on therapy for patients
with resistant hypertension and in expanding Myogen's product pipeline to a
third compound for a third indication."
The primary objective of the Phase IIb randomized, double-blind, placebo-
controlled trial is to determine if darusentan is effective in reducing
systolic blood pressure in patients with resistant systolic hypertension.
Resistant hypertension is defined by The Seventh Report of the Joint National
Committee on Prevention, Detection, Evaluation and Treatment of High Blood
Pressure sponsored by the National Institutes of Health (JNC7) as the failure
to achieve goal blood pressure in patients who are adhering to full doses of
an appropriate three-drug regimen that includes a diuretic. Approximately 105
patients will be randomized to darusentan or placebo at approximately 30
investigative sites. Patients will undergo forced titration every two weeks
through 10, 50, 100 and 150 mg of darusentan or placebo until the target dose
of 300 mg once a day is achieved. The treatment period for the study is 10
weeks.
Darusentan is a type-A selective endothelin receptor antagonist and potent
inhibitor of endothelin-induced vasoconstriction. Endothelin is a small
peptide hormone that is believed to play a critical role in the control of
blood flow and cell growth. Elevated endothelin blood levels are associated
with several cardiovascular disease conditions, including pulmonary arterial
hypertension, chronic kidney disease, hypertension, chronic heart failure,
stroke and reclosure of coronary arteries after balloon angioplasty or stent
implantation. Therefore, many scientists believe that agents that block the
detrimental effects of endothelin will provide significant benefits in the
treatment of these conditions. Darusentan is selective for the ET(A) receptor
versus the ET(B) receptor and demonstrates a half-life that may be suitable
for once a day dosing.
In 2000, the original sponsor of darusentan evaluated the safety and
efficacy of darusentan in 392 patients with moderate essential hypertension in
a Phase II/III randomized, double-blind, placebo-controlled, dose-ranging
trial. The primary endpoint of the trial was change in sitting diastolic
blood pressure after six weeks of treatment.
The results of this study demonstrated that darusentan produced
statistically significant and clinically meaningful reductions in diastolic
and systolic blood pressures in a dose-dependent manner. The mean placebo-
corrected change from baseline in systolic blood pressure was -6.0 mmHg on
10 mg, -7.3 mmHg on 30 mg and -11.3 mmHg on 100 mg darusentan after six weeks
of treatment. Significant reductions in diastolic blood pressure were also
observed (-3.7, -4.9 and -8.3 mmHg, for the three dose groups, respectively).
Heart rate remained unchanged in all groups. Headache was the most commonly
reported adverse event, with no relevant difference among placebo and active
treatment groups. Flushing and peripheral edema were seen in a dose-dependent
fashion in the darusentan treatment groups. There were no treatment-related
elevations in liver function tests in the study. This study was conducted
with a different patient population and protocol than is being studied in the
Company's Phase IIb clinical trial and there can be no assurances that Myogen
will see the same results in its Phase II study as those reported in this
study.
About Hypertension
Hypertension affects approximately 50 million individuals in the United
States and approximately one billion worldwide. Despite the availability and
use of several classes of drugs (diuretics, ACE inhibitors, angiotensin
receptor blockers, beta-blockers, calcium channel blockers, alpha receptor
agents and vasodilators) to treat hypertension, many of these patients do not
achieve goal blood pressures within the recommended range, a condition
described as "resistant hypertension". Many of these patients have diabetes,
chronic kidney disease or both. The relationship between blood pressure and
cardiovascular events is continuous, consistent and independent of other risk
factors. The likelihood of patients developing cardiovascular and renal
complications rises as blood pressure increases.
About Myogen
Myogen is a biopharmaceutical company focused on the discovery,
development and commercialization of small molecule therapeutics for the
treatment of cardiovascular disorders. Myogen currently markets one product
in Europe for the treatment of acute decompensated heart failure and has three
product candidates in late-stage clinical development: enoximone capsules for
the treatment of chronic heart failure, ambrisentan for the treatment of
pulmonary arterial hypertension and darusentan for the treatment of resistant
hypertension. The Company, in collaboration with Novartis, also conducts a
target and drug discovery research program focused on the development of
disease-modifying drugs for the treatment of chronic heart failure and related
cardiovascular disorders. Please visit Myogen's website at http://www.myogen.com.
Safe Harbor Statement
This press release contains forward-looking statements that involve
significant risks and uncertainties, including those discussed in this release
and others that can be found in the "Risk Factors" section of Myogen's Form
10-K for the year ended December 31, 2003 and in Myogen's periodic reports on
Form 10-Q and Form 8-K. Myogen is providing this information as of the date
of this release and does not undertake any obligation to update any forward-
looking statements contained in this document as a result of new information,
future events or otherwise.
The Company cautions investors not to place undue reliance on the forward-
looking statements contained in this press release. No forward-looking
statement can be guaranteed and actual events and results may differ
materially from those projected. The Company's results may be affected by its
effectiveness at managing its financial resources, its ability to successfully
develop and market current and new products, difficulties or delays in its
clinical trials, difficulties or delays in manufacturing its products, and
regulatory developments involving current and future products. Delays in
clinical trials, whether caused by adverse events, patient enrollment rates,
regulatory issues or other factors, could adversely affect the Company's
financial position and prospects. Results from earlier clinical trials are
not necessarily predictive of future clinical trial results. If the Company
is unable to raise additional capital when required or on acceptable terms, it
may have to significantly delay, scale back or discontinue one or more of its
drug development or discovery research programs. Myogen is at an early stage
of development and may not ever have any products that generate significant
revenue.
SOURCE Myogen
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Related links:
http://www.myogen.com
CONTACT:
Derek K. Cole, Director, Investor Relations,
+1-303-464-3986, derek.cole@myogen.com, or Joseph L. Turner,
Chief Financial Officer, +1-303-464-5222, joe.turner@myogen.com,
both of Myogen
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