Nancy
Well-known member
Here's some interesting info. for CHF patients about drug trials for enoximone:
This is from the drug manufacturer:
Wednesday February 6, 8:07 am Eastern TimePress Release
SOURCE: Myogen, Inc.
Myogen, Inc. Begins Phase III Pivotal Enoximone Trial
DENVER, Feb. 6 /PRNewswire/ -- Myogen, Inc., a Colorado-based biopharmaceutical company dedicated to discovering, developing and commercializing drugs for the treatment of heart failure and related cardiovascular complications, announced today that it commenced patient enrollment in its pivotal Phase III clinical trial of low dose oral enoximone in patients with advanced heart failure. This study is referred to as ``ESSENTIAL''. Myogen plans to conduct ESSENTIAL in approximately 240 sites in North and South America and Western and Eastern Europe. The Phase III program, if successful, is expected to be sufficient to support regulatory registration of enoximone on a worldwide basis.In this randomized, placebo-controlled multi-center trial, it is expected that approximately 1400 patients suffering from NYHA Class III & IV chronic heart failure will be treated with either placebo or oral enoximone (25 or 50 mg t.i.d.) for at least 52 weeks. The Phase III trial will assess the safety and efficacy of oral enoximone in reducing the incidence of death or cardiovascular hospitalizations, improving patient well-being, and increasing exercise capacity.``The commencement of ESSENTIAL is an important development and corporate milestone for Myogen,'' stated J. William Freytag, President and Chief Executive Officer of Myogen. ``In addition, we have reached the halfway point in the EMOTE trial, our first Phase III trial of low dose oral enoximone. EMOTE is a randomized, placebo-controlled trial of 200 patients suffering from ultra-advanced heart failure, and is designed to assess the safety and efficacy of oral enoximone in reducing patients' dependency on intravenous inotropes as well as the incidence of death or cardiovascular hospitalizations.''``There are few therapies available today for the palliation of advanced heart failure. If enoximone proves to be safe and effective it will be one of the more important new therapies available for these patients,'' stated Michael Bristow, MD, PhD, Chief of Cardiology at the University of Colorado Health Sciences Center in Denver, and Myogen Chief Science and Medical Officer.Chronic heart failure (CHF) is a debilitating condition that occurs as the heart becomes progressively less able to pump an adequate supply of blood throughout the body. CHF has many causes, generally beginning in patients with a life-long history of high blood pressure or after a patient has suffered a major heart attack or some other heart-damaging event. CHF itself may lead to other complicating factors such as pulmonary hypertension, edema, pulmonary edema, liver dysfunction and kidney failure. CHF is one of the largest health problems in the developed world, with costs in the United States alone exceeding $30 billion annually. In the United States, approximately five million patients are afflicted with CHF, with an additional 550,000 new cases reported each year. It is estimated that half of all CHF patients die within five years of diagnosis.Myogen is a privately held biopharmaceutical company engaged in the discovery and development of drugs for the treatment of heart failure and related cardiovascular conditions. The company's strategy aims to leverage its research and clinical expertise in heart muscle disease toward the development of a portfolio of novel cardiovascular therapeutics. The company is currently evaluating two drugs in human clinical studies: enoximone, a positive inotropic agent that increases the force of contraction of the heart, and ambrisentan, a member of a new class of drugs referred to as endothelin receptor antagonists, which the Company intends to develop for the treatment of chronic heart failure, chronic renal failure, and pulmonary arterial hypertension. Myogen sells Perfan®I.V., the intravenous form of enoximone, in Europe. In addition, Myogen's research efforts have identified several novel therapeutic targets involved in heart failure for which the company has begun drug discovery efforts. Myogen occupies 30,000 square feet of laboratory and office space in the Denver, Colorado area and currently has approximately 40 employees.
Please visit our website at www.myogen.com . SOURCE: Myogen, Inc.
This is from a press release from Albany Medical Center (Albany, New York)
http://heart.amc.edu/clinical_research_program.htm
This is from the drug manufacturer:
Wednesday February 6, 8:07 am Eastern TimePress Release
SOURCE: Myogen, Inc.
Myogen, Inc. Begins Phase III Pivotal Enoximone Trial
DENVER, Feb. 6 /PRNewswire/ -- Myogen, Inc., a Colorado-based biopharmaceutical company dedicated to discovering, developing and commercializing drugs for the treatment of heart failure and related cardiovascular complications, announced today that it commenced patient enrollment in its pivotal Phase III clinical trial of low dose oral enoximone in patients with advanced heart failure. This study is referred to as ``ESSENTIAL''. Myogen plans to conduct ESSENTIAL in approximately 240 sites in North and South America and Western and Eastern Europe. The Phase III program, if successful, is expected to be sufficient to support regulatory registration of enoximone on a worldwide basis.In this randomized, placebo-controlled multi-center trial, it is expected that approximately 1400 patients suffering from NYHA Class III & IV chronic heart failure will be treated with either placebo or oral enoximone (25 or 50 mg t.i.d.) for at least 52 weeks. The Phase III trial will assess the safety and efficacy of oral enoximone in reducing the incidence of death or cardiovascular hospitalizations, improving patient well-being, and increasing exercise capacity.``The commencement of ESSENTIAL is an important development and corporate milestone for Myogen,'' stated J. William Freytag, President and Chief Executive Officer of Myogen. ``In addition, we have reached the halfway point in the EMOTE trial, our first Phase III trial of low dose oral enoximone. EMOTE is a randomized, placebo-controlled trial of 200 patients suffering from ultra-advanced heart failure, and is designed to assess the safety and efficacy of oral enoximone in reducing patients' dependency on intravenous inotropes as well as the incidence of death or cardiovascular hospitalizations.''``There are few therapies available today for the palliation of advanced heart failure. If enoximone proves to be safe and effective it will be one of the more important new therapies available for these patients,'' stated Michael Bristow, MD, PhD, Chief of Cardiology at the University of Colorado Health Sciences Center in Denver, and Myogen Chief Science and Medical Officer.Chronic heart failure (CHF) is a debilitating condition that occurs as the heart becomes progressively less able to pump an adequate supply of blood throughout the body. CHF has many causes, generally beginning in patients with a life-long history of high blood pressure or after a patient has suffered a major heart attack or some other heart-damaging event. CHF itself may lead to other complicating factors such as pulmonary hypertension, edema, pulmonary edema, liver dysfunction and kidney failure. CHF is one of the largest health problems in the developed world, with costs in the United States alone exceeding $30 billion annually. In the United States, approximately five million patients are afflicted with CHF, with an additional 550,000 new cases reported each year. It is estimated that half of all CHF patients die within five years of diagnosis.Myogen is a privately held biopharmaceutical company engaged in the discovery and development of drugs for the treatment of heart failure and related cardiovascular conditions. The company's strategy aims to leverage its research and clinical expertise in heart muscle disease toward the development of a portfolio of novel cardiovascular therapeutics. The company is currently evaluating two drugs in human clinical studies: enoximone, a positive inotropic agent that increases the force of contraction of the heart, and ambrisentan, a member of a new class of drugs referred to as endothelin receptor antagonists, which the Company intends to develop for the treatment of chronic heart failure, chronic renal failure, and pulmonary arterial hypertension. Myogen sells Perfan®I.V., the intravenous form of enoximone, in Europe. In addition, Myogen's research efforts have identified several novel therapeutic targets involved in heart failure for which the company has begun drug discovery efforts. Myogen occupies 30,000 square feet of laboratory and office space in the Denver, Colorado area and currently has approximately 40 employees.
Please visit our website at www.myogen.com . SOURCE: Myogen, Inc.
This is from a press release from Albany Medical Center (Albany, New York)
http://heart.amc.edu/clinical_research_program.htm
