Heart Disease

Chronic Heart Failure Trial Using Mesoblast’s Receives FDA Clearance

Chronic Heart Failure Trial Using Mesoblast’s Receives FDA Clearance

Chronic Heart Failure Trial Using Mesoblast’s Receives FDA Clearance

Chronic Heart Failure Trial Using Mesoblast’s, Receives FDA Clearance

 

NBN Infusions delivers comprehensive services to patients of all ages, from pediatric to geriatric, providing a full range of care for Home Infusion Therapy. NBN Infusions on-site, licensed pharmacy can provide prescription medications, equipment, supplies and skilled nursing care needed for Home Infusion Therapy.

Home Infusion Therapy is a more convenient and cost-effective option than traditional inpatient therapy, with care administered in the comfortable surroundings of one’s own home. Home Infusion Therapy allows for a more active role in one’s own health care. It can also ease stress and anxiety that is sometimes associated with inpatient treatment, resulting in better patient outcomes.

 

Mesoblast Limited’s development and commercial partner Teva Pharmaceuticals Industries Ltd has received the United States Food and Drug Administration (FDA clearance to begin phase III trial in patients with chronic congestive heart failure using Mesoblast’s proprietary Mesenchymal Precursor Cells (MPCs). The IND was cleared by the FDA within the minimum 30-day period following submission, and patient recruitment is expected to begin shortly.

 

The multi-centre trial, which will be conducted by Teva, is planned to enrol approximately 1,700 patients and includes two interim analyses of efficacy and/or safety. The clinical protocol was designed after initial consultation with both the FDA and the European Medicines Agency.

 

The phase II trial design is a double-blinded, 1:1 randomized, placebo-controlled study evaluating a single dose of 150 million MPCs delivered via transendocardial injection catheter to the left ventricle of heart failure patients with New York Heart Association (NYHA) class II or III disease and an ejection fraction = 40%. The primary efficacy endpoint of the trial is a time-to-first event analysis of heart failure-related Major Adverse Cardiac Events (HF-MACE), defined as a composite of cardiac related death or resuscitated cardiac death, or non-fatal decompensated heart failure events. These nonfatal decompensated heart failure events require use of intravenous diuretics or aquapheresis during an in-hospital stay or during an outpatient visit. Adjudication of HF-MACE will be performed by an independent, blinded clinical endpoint committee.

 

The MPC dose for the phase III trial was chosen on the basis of results from a 60-patient phase II trial which has shown that heart failure patients treated with the 150 million MPC dose have not experienced any HF-MACE over the three-year follow-up period compared with an HF-MACE incidence of approximately 30 per cent for the control group over the same period.

 

Mesoblast chief executive Silviu Itescu said: “We believe that Mesoblast’s proprietary mesenchymal lineage cells have the potential to offer long-term beneficial outcomes to the millions of patients suffering from heart failure worldwide. Importantly, in 2014 we plan to have products in active phase III clinical trials in all four of our core major therapeutic areas of focus: cardiovascular medicine (congestive heart failure), inflammatory/immune diseases (Crohn’s disease), orthopedics (spinal fusion and intervertebral disc repair) and oncology (acute Graft versus Host Disease, and cord blood expansion in bone marrow transplantation).”

 

Mesoblast Limited is a world leader in the development of biologic products for the broad field of regenerative medicine.

 

Originally Posted: http://www.pharmabiz.com

 

Heart Disease Risk Quadruples in Women under 60 with Diabetes, Study

Heart Disease Risk Quadruples in Women under 60 with Diabetes, Study

Heart Disease Risk Quadruples in Women under 60 with Diabetes, Study

 

Heart Disease Risk Quadruples in Women under 60 with Diabetes, Study

 

NBN Infusions delivers comprehensive services to patients of all ages, from pediatric to geriatric, providing a full range of care for Home Infusion Therapy. NBN Infusions on-site, licensed pharmacy can provide prescription medications, equipment, supplies and skilled nursing care needed for Home Infusion Therapy.

Home Infusion Therapy is a more convenient and cost-effective option than traditional inpatient therapy, with care administered in the comfortable surroundings of one’s own home. Home Infusion Therapy allows for a more active role in one’s own health care. It can also ease stress and anxiety that is sometimes associated with inpatient treatment, resulting in better patient outcomes.

 

 

Women, who are younger than 60 years old and suffering from type-2 diabetes, face greater risk of coronary artery disease than previously believed, according to a John Hopkins study.

 

 Generally, it is assumed that women under 60 have less risk of developing coronary heart disease than men. The latest study shows that women with diabetes have four times higher chance of heart disease.

For the study, the researchers gathered data of 10,000 people from three highly regarded medical surveys. None of the participants had a history of heart disease at the start of the study.

 

“Our findings suggest that we need to work harder to prevent heart disease in women under 60 who have diabetes,” Rita Rastogi Kalyani, lead study author and endocrinologist, said in a official statement. “This study tells us that women of any age who have diabetes are at a high risk for coronary artery disease.”

“Our study adds to growing evidence that gender differences exist in the risk of coronary artery disease brought on by diabetes.”

Although men are generally at higher risk of getting heart disease than women, the study found that diabetes was not considered as a factor for developing the disease in this gender.

 Kalyani told dailyRx News, “Men in this age group have a high risk of heart disease to begin with and the additional presence of diabetes does not seem to increase the risk of heart disease substantially further.”

The study has been published in the journal Diabetes Care.

“There may be distinct genetic and hormonal factors related to the development of heart disease by gender. Differences in adherence to heart-healthy lifestyle behaviors, compliance and treatment of cardiovascular treatments between genders are also possible but need to be further investigated” Kalyani said in a statement. “Also, the relationship of diabetes duration and glucose control to risk of heart disease remains unclear.”

 

Originally Posted: http://www.universityherald.com