Cardiomyopathy News and Research

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Cardiomyopathy is a group of diseases with primary, usually diffuse, involvement of the myocardium. The myocardial disease is not secondary to ischaemic, valvular, congenital or pericardial disease.

Alnylam Pharmaceuticals initiates dosing in Phase I human clinical study with ALN-TTR01

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today it has initiated dosing in a Phase I human clinical study with ALN-TTR01. The study is aimed at evaluating the safety and tolerability of ALN-TTR01 in patients with transthyretin -mediated amyloidosis, and is also designed to provide preliminary data on human proof of concept based on measurements of TTR serum levels.

7 Jul 2010

Aastrom to pursue Phase 3 CLI clinical program through FDA SPA process

Aastrom Biosciences, Inc., the leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, today announced that the company will pursue a Phase 3 clinical program for its autologous cell therapy for the treatment of critical limb ischemia (CLI) through the U.S. Food and Drug Administration's special protocol assessment (SPA) process. Aastrom is currently completing a Phase 2b clinical trial of its cell therapy in patients with CLI and recently met with FDA officials to discuss plans for the Phase 3 program.

7 Jul 2010

Shire receives FDA approval of Daytrana for ADHD in adolescents

Shire plc, the global specialty biopharmaceutical company, announced the US Food and Drug Administration (FDA) approval of Daytrana® (methylphenidate transdermal system) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents aged 13 to 17 years. Daytrana, the first and only transdermal ADHD patch, is already an FDA-approved ADHD treatment for children 6 to 12 years. Daytrana is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social).

7 Jul 2010

Alnylam receives Portuguese, Swedish, British approvals to initiate ALN-TTR01 Phase I study in ATTR

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that its applications for ALN-TTR01 have been given clearance by Portuguese, Swedish, and British regulatory authorities to begin clinical testing. The trial will begin enrolling patients shortly in a blinded, randomized, placebo-controlled, multicenter Phase I study.

29 Jun 2010

St. Jude Medical commences enrollment in LAPTOP-HF study

St. Jude Medical, Inc., a global medical device company, today announced the first enrollment in its LAPTOP-HF (Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy) study. The goal of the LAPTOP-HF study is to demonstrate that the new investigational left atrial pressure (LAP) management system safely and effectively improves outcomes in patients with heart failure (HF).

17 Jun 2010

Phase 2b RESTORE-CLI clinical trial in patients with CLI reaches statistical significance

Richard J. Powell, M.D., section chief of vascular surgery at the Dartmouth-Hitchcock Medical Center in Lebanon, NH and a principal investigator of the U.S. Phase 2b RESTORE-CLI clinical trial sponsored by Aastrom Biosciences, will present the full results from the interim analysis at today's session of the annual meeting of the Society for Vascular Surgery.

11 Jun 2010

PPMD to fund two promising research initiatives in Duchenne muscular dystrophy

Patricia A. Furlong, Founding President and CEO of Parent Project Muscular Dystrophy (PPMD), the largest non-profit organization in the United States focused on finding a cure for Duchenne muscular dystrophy (Duchenne), announced today that PPMD will be funding two critical, promising research initiatives in Duchenne.

11 Jun 2010

Researchers differentiate human stem cells to become heart cells with cardiomyopathy

Researchers at Mount Sinai School of Medicine have for the first time differentiated human stem cells to become heart cells with cardiomyopathy, a condition in which the heart muscle cells are abnormal. The discovery will allow scientists to learn how those heart cells become diseased and from there, they can begin developing drug therapies to stop the disease from occurring or progressing. The study is published in the June 9th issue of Nature.

10 Jun 2010

4% of South Asian people carry mutated gene that causes heart failure

One in 25 people from India and other south Asian countries carries a mutated gene that causes heart failure.

9 Jun 2010

SERCA2a gene therapy proves effective in people with advanced heart failure: Researchers

Researchers at Mount Sinai School of Medicine have developed a new gene therapy that is safe and effective in reversing advanced heart failure. SERCA2a (produced as MYDICAR-) is a gene therapy designed to stimulate production of an enzyme that enables the failing heart to pump more effectively.

4 Jun 2010

Phase 1 clinical trial of OXY111A initiated

NormOxys Inc., a biotechnology company developing a novel class of small molecule drugs which enhance the body's ability to deliver oxygen to diseased tissues, today announced that it has initiated a Phase 1 clinical trial of OXY111A, a novel allosteric modulator of affinity of oxygen to hemoglobin. NormOxys plans to initially develop this compound as a treatment for chronic heart failure and cancer indications.

24 May 2010

New research seeks customised treatment of cardiovascular diseases

The Centre for Cooperative Research in Biomaterials, CIC biomaGUNE, is involved in the research consortium of cvREMOD, which aims to move forward in the attainment of new diagnosis techniques for prevention and customised treatment of cardiovascular diseases in the upcoming four years.

21 May 2010

Aastrom Biosciences initiates treatment in Phase 2 catheter-based clinical trial for dilated cardiomyopathy

Aastrom Biosciences, Inc., the leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, today announced that the first patient has been treated in the company's U.S. Phase 2 catheter-based clinical trial to treat dilated cardiomyopathy (DCM). Treatment was performed by interventional cardiologist Timothy D. Henry, M.D., FACC, at the Minneapolis Heart Institute® at Abbott Northwestern Hospital in Minneapolis, MN.

17 May 2010

ARCA biopharma announces SPA agreement with FDA for bucindolol clinical trial

ARCA biopharma, Inc. today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a clinical trial to assess the safety and efficacy of bucindolol in approximately 3,200 patients with chronic heart failure who have the genotype that appears to respond most favorably to bucindolol. Bucindolol is the Company's investigational, pharmacologically unique, beta-blocker and mild vasodilator.

17 May 2010

Medtronic releases Virtual ICD study data

Medtronic, Inc. released the Virtual ICD study data today that predicted 98 percent of studied implantable defibrillator patients would be free of inappropriate shocks one year after implant and 92 percent at five years post-implant.

14 May 2010

Repligen files IND for Phase 1 study of RG2833 selective HDAC-3 inhibitor for Friedreich's ataxia

Repligen Corporation announced today that it has filed an Investigational New Drug Application (IND) with the Food and Drug Administration (FDA) for a Phase 1 study of RG2833, a selective histone deacetylase 3 (HDAC-3) inhibitor. This is a double-blind, single ascending dose, Phase 1 study in healthy volunteers to evaluate the pharmacokinetic and safety profile of RG2833 in up to 40 subjects.

13 May 2010

Clinical Data expands PGxHealth's FAMILION tests to include two new tests to diagnose heart diseases

Clinical Data, Inc., announced today that its PGxHealth division is expanding its FAMILION family of genetic tests to include two new tests to diagnose heart diseases. With the launch of a test for Conduction Disease associated with Dilated Cardiomyopathy and a test for Short QT Syndrome, PGxHealth continues to lead the industry with the most comprehensive menu of genetic tests to diagnose or confirm familial heart diseases.

12 May 2010

Aastrom Biosciences reports third quarter 2010 FY results

Aastrom Biosciences, Inc., the leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, today reported financial results for its third fiscal quarter ended March 31, 2010, and also announced progress in its late-stage clinical development programs and corporate operations.

11 May 2010

Deficiency of frataxin protein causes Friedreich's ataxia

The defective gene responsible for Friedreich's ataxia was identified over 20 years ago, but so far our ideas of how this gene causes the disease have been merely speculative. It was assumed that, as a result of the mutation, the gene could no longer be transcribed because this stretch of DNA was inaccessible. FMI Group Leader Marc Bühler and his team have now carried out experiments demonstrating that this is not the case and revealing what actually happens in Friedreich's ataxia.

4 May 2010

Researchers use healthy person's complete genome sequence to predict risk for dozens of diseases

For the first time, researchers have used a healthy person's complete genome sequence to predict his risk for dozens of diseases and how he will respond to several common medications. The risk analysis, from the Stanford University School of Medicine, also incorporates more-traditional information such as a patient's age and gender and other clinical measurements.

30 Apr 2010

Cardiomyopathy News and Research

Further Reading

Alnylam Pharmaceuticals initiates dosing in Phase I human clinical study with ALN-TTR01

Aastrom to pursue Phase 3 CLI clinical program through FDA SPA process

Shire receives FDA approval of Daytrana for ADHD in adolescents

Alnylam receives Portuguese, Swedish, British approvals to initiate ALN-TTR01 Phase I study in ATTR

St. Jude Medical commences enrollment in LAPTOP-HF study

Phase 2b RESTORE-CLI clinical trial in patients with CLI reaches statistical significance

PPMD to fund two promising research initiatives in Duchenne muscular dystrophy

Researchers differentiate human stem cells to become heart cells with cardiomyopathy

4% of South Asian people carry mutated gene that causes heart failure

SERCA2a gene therapy proves effective in people with advanced heart failure: Researchers

Phase 1 clinical trial of OXY111A initiated

New research seeks customised treatment of cardiovascular diseases

Aastrom Biosciences initiates treatment in Phase 2 catheter-based clinical trial for dilated cardiomyopathy

ARCA biopharma announces SPA agreement with FDA for bucindolol clinical trial

Medtronic releases Virtual ICD study data

Repligen files IND for Phase 1 study of RG2833 selective HDAC-3 inhibitor for Friedreich's ataxia

Clinical Data expands PGxHealth's FAMILION tests to include two new tests to diagnose heart diseases

Aastrom Biosciences reports third quarter 2010 FY results

Deficiency of frataxin protein causes Friedreich's ataxia

Researchers use healthy person's complete genome sequence to predict risk for dozens of diseases

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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