Clinical Research

Researchers from the Universitat Autònoma de Barcelona report they can cure diabetes in large animals with a single session of gene therapy. Writing in Diabetes, they said the dogs recovered their health and no longer show symptoms of the disease. In some cases, monitoring continued for over four years, with no recurrence of symptoms.


The European Food Safety Authority (EFSA) has reviewed field performance data of the BOVIGAM(R)Interferon-gamma (IFN-gamma) test and recommended such tests for inclusion in the official list of stand-alone tests for bovine tuberculosis (TB). BOVIGAM is currently widely used as a supplementary test in addition to skin testing. The Prionics company believes the positive EFSA opinion will lead to the use of BOVIGAM as a stand-alone TB test in the European Union. 


By combining insulin and an inhibitor of the epidermal growth factor (EGF) betacellulin,  Cleveland Clinic researcher Bela Anand-Apte, MD, PhD
was able to halt the progression of diabetic macular edema (DME), according to data preseneted at the American Society for Cell Biology Annual Meeting last week in San Francisco.

The study, conducted with insulin-dependent diabetic mice, showed that by thwarting "cross-talk" between insulin and betacellulin (BTC), which promotes the regeneration of pancreatic beta cells that stores and releases insulin, the EGF inhibitor preserved the animals' vascular integrity, she explained.


Scientists have discovered a new gene mechanism that appears to regulate triglyceride levels and may protect carriers of a gene variant against cardiovascular disease, especially among those with greater intakes of polyunsaturated fat (PUFA).  


Clinical trials are obviously important.  The results influence what drugs are approved by regulatory bodies, which can have a billion-dollar impact on companies.

Clinical trials have always been sponsored by industry - there has never been a meaningful  government-controlled research effort toward drug creation - but they have increasingly come under fire, due to claims that an industry sponsor can influence results and how they are reported to present their company and products in a better light.


New cells develop in the heart but how these cardiac cells are born and how frequently they are generated remains unclear. New research from Brigham and Women's Hospital used a novel method to identify these new heart cells and describe their origins - a Multi-isotope Imaging Mass Spectrometry (MIMS) imaging system that demonstrates cell division in the adult mammalian heart. 



Cardio3 BioSciences (C3BS) announced it has received authorization from the Belgian Federal Agency for Medicines and Health Products (FAMHP) to begin its Congestive Heart failure Cardiopoietic Regenerative Therapy (CHART-1) European Phase III trial for C3BS-CQR-1 in Belgium. This represents a world premiere for a regenerative medicine product targeting heart failure to be tested in the context of a Phase III trial. C3BS-CQR-1 is an autologous stem cell therapy for heart failure. 


Autologous stem cells from bone marrow 3 or 7 days following a heart attack did not improve heart function six months later, according to a new clinical trial. 

The results of this TIME (Transplantation In Myocardial Infarction Evaluation) trial were presented by Jay Traverse, MD of the Minneapolis Heart Institute Foundation Tuesday, today at the 2012 Scientific Sessions of the American Heart Association in Los Angeles.

The results of this trial mirror a previous, related study (LateTIME) which found that autologous bone marrow stem cell therapy given 2-3 weeks after a heart attack did not improve cardiac recovery. Both TIME and LateTIME were carried out by the Cardiovascular Cell Therapy Research Network (CCTRN).

Medivir AB has announced plans for a phase II proof-of-concept study of an all-oral regimen for the treatment of hepatitis C containing of Medivir/Janssen's protease inhibitor simeprevir and Vertex's nucleotide analogue hepatitis C virus (HCV) polymerase inhibitor VX-135. Janssen will conduct a drug-drug interaction study with simeprevir and VX-135 to support the planned initiation of a phase II proof-of-concept study in early 2013, pending discussions with regulatory authorities.