A new combination therapy allows chronic hepatitis C to be treated in a manner that is less aggressive yet equally efficient. This is the result of a current study, led by primary author Peter Ferenci from the University Department of Internal Medicine III at the MedUni Vienna, which has been published in the highly respected New England Journal of Medicine. “This is a revolutionary breakthrough in the treatment of this disease and represents a huge improvement in the quality of life of those affected,” says the Vienna hepatologist.

Ferenci and a global group of scientists were able to demonstrate using 419 test subjects with chronic hepatitis C that the combined use of the protease inhibitor ABT-450r, the NS5A inhibitor Ombitasvir and the non-nucleoside polymerase inhibitor Dasubavir yields significantly higher cure outcomes than the previous therapy which involves Ribavarin and the hormone interferon (mostly in combination with a protease inhibitor)…

Researchers at Norris Cotton Cancer Center have found an antibody that may be used in future treatments for recurrent small-cell lung cancer, which currently has no effective therapy.

The mouse monoclonal antibody they have developed, MAG-1, targets the ProAVP surface marker. When given alone, it significantly slows the growth of tumor xenografts of human recurrent small-cell lung cancer in mice. The study, “Growth Impairment of Small-Cell Cancer by Targeting Pro-Vasopressin with MAG-1 Antibody,” was recently published online in Frontiers in Oncology.

“We are developing methods of antibody-targeted treatment for recurrent small-cell lung cancer,” said lead author William G. North, PhD, professor of Physiology at the Geisel School of Medicine at Dartmouth and a member of the Norris Cotton Cancer Center. “Targeting with a humanized MAG-1 can likely be effective, especially when given in combination with chemotherapy, for treating a deadly disease for which there is no effective therapy.”

An old idea of retreating lung tumors with radiation is new again, especially with the technological advances seen in radiation oncology over the last decade.

The Comprehensive Cancer Center of Wake Forest Baptist Medical Center is one of only a handful of cancer centers that is attempting to give lung cancer patients out of treatment options a chance to keep the cancer at bay. For these patients, hope lies in a second course of treatment – repeat radiation. Two complementary papers published back-to-back recently in the journal Radiotherapy and Oncology and the Journal of Thoracic Oncology outline the treatment success at Wake Forest Baptist.

“One of the toughest challenges of lung cancer is what to do for patients when the cancer comes back in an area that’s been treated previously with radiation treatment,” said James J. Urbanic, M.D., lead author of the studies and a radiation oncologist at…

Investigators at the Cedars-Sinai Heart Institute – whose previous research showed that cardiac stem cell therapy reduces scarring and regenerates healthy tissue after a heart attack in humans – have identified components of those stem cells responsible for the beneficial effects.

In a series of laboratory and lab animal studies, Heart Institute researchers found that exosomes, tiny membrane-enclosed “bubbles” involved in cell-to-cell communication, convey messages that reduce cell death, promote growth of new heart muscle cells and encourage the development of healthy blood vessels.

“Exosomes were first described in the mid-1980s, but we only now are beginning to appreciate their potential as therapeutic agents. We have found that exosomes and the cargo they contain are crucial mediators of stem cell-based heart regeneration, and we believe this might lead to an even more refined therapy using the ‘active ingredient’ instead of the entire stem cell,” said Eduardo Marbán, MD, PhD, director…

For the EMA, it was necessary to develop an independent guideline on the topic as – despite the existence of harmonised ICH documents – specific aspects of the validation of biotechnology-derived products have been missing. A draft is now available.

A draft is now available.

EMA publishes Guideline Draft on Validation of biotechnology-derived Products

How to become a QP for Europe
Both the ECA and the European QP Association are often contacted by people who would like to become a Qualified Person in a Member State of the European Union or outside the EU to release products for the EU market. Read more.

Read more.

An antioxidant that targets specific cell structures—mitochondria—may be able to reverse some of the negative effects of aging on arteries, reducing the risk of heart disease, according to a new study by the University of Colorado Boulder.

When the research team gave old mice—the equivalent of 70- to 80-year-old humans—water containing an antioxidant known as MitoQ for four weeks, their arteries functioned as well as the arteries of mice with an equivalent human age of just 25 to 35 years.

The researchers believe that MitoQ affects the endothelium, a thin layer of cells that lines our blood vessels. One of the many functions of the endothelium is to help arteries dilate when necessary. As people age, the endothelium is less able to trigger dilation and this leads to a greater susceptibility to cardiovascular disease.

“One of the hallmarks of primary aging is endothelial dysfunction,” said Rachel Gioscia-Ryan, a…

An untreated neuroblastoma cell.

Children fighting a life-threatening form of cancer could be treated with a revolutionary anti-cancer therapy as early as next year, following the formation of a research alliance to fast-track development of a medicine pioneered by Australian researchers.

The Children’s Oncology Drug Alliance (CODA) unites the research and resources of UNSW Australia and its commercialisation arm, NewSouth Innovations, childhood cancer research charity The Kids’ Cancer Project, ASX-listed Australian biotechnology-company Novogen, and Nationwide Children’s Hospital, Columbus, Ohio, to accelerate development of a treatment purpose-built for neuroblastoma – the most common form of cancer in infancy.

Currently there is no medicine approved to treat neuroblastoma, a cancer that affects up to 100 children in Australia and around 650 in the United States each year. Childhood cancers – which claim the lives of three Australian children every week – are currently treated with chemotherapies that have been developed for adults…