Clinical Research Focus. 11th Edition

Serbia – The Land of Opportunity in Clinical Research

Over the years, Serbia has become a highly reputable location to conduct clinical research. The country has actively strived towards developing a robust healthcare system and adopted full GCP compliance. There are 322 clinical trials currently occurring inside Serbia’s borders.

Increasing number of biotechnology and pharmaceutical companies are now willing to see Serbia as a potential regional hub for their business operations and thus make significant investments in the Serbian clinical trials market.

Please read more about Serbia and clinical trials here. 

FDA Approves First Treatment to Delay the Onset of Type 1 Diabetes

Recently, a biologic therapy that hinders the onset of type 1 diabetes received support from the US Food and Drug Administration. The monoclonal antibody teplizumab, that is given intravenously, will be marketed by ProventionBio and Sanofi and will be sold under the brand name Tzield. The drug comes at a cost of $194,000 for the full course of treatment. In recent clinical trials teplizumab slowed the progression to overt diabetes for at least two years. However, the advantages have persisted much longer in a subgroup of the study participants. 

The chief spokesman for the drug therapy, Aaron Kowalski, CEO of JDRF, says the major challenge with Tzield will be in identification of individuals who require it. Currently, the drug is approved for patients without clinical symptoms who are still producing insulin. 

“Screening becomes a huge issue because what we know is about 85% of type 1 diagnoses today are in families that don’t have a known family history. We aim to do general population screening with blood tests to look for disease markers.’ said Kowalski. 

For more information about teplizumab, please click here.

Lab-Grown Blood Given to Humans in a World-First Trial Aimed at Combatting Rare Disorders

Artificial blood developed in a laboratory has been transfused into humans for the first time in a hallmark clinical trial that UK researchers say could vastly enhance treatment options for people with blood disorders and rare blood types. The trial will recruit ten patients over several months, aiming to explore the lifespan of lab-grown cells compared with infusions of conventional red blood cell products.

The end goal claimed by researchers is not to replace traditional human blood donations, which will continue to make up most transfusions. This new technology, however, will permit scientists to manufacture rare blood types that are challenging to source but essential for individuals who rely on routine blood transfusions for disorders such as sickle cell anemia.

So far, two patients in the UK have received small doses of the lab-grown blood as part of a more expansive trial to see how it behaves in vivo.

For more information, please follow the link.

Clinical Trials in Rare Diseases: More Attention Is Still Needed

As implied in its name, rare diseases affect small percentages of patients. However, when factoring in the multitude of rare diseases, the overall number of people affected by them is a staggering 475 million worldwide.

According to the National Institutes of Health, between 235 and 30 million Americans have over 6,800 rare diseases, which amounts to 1 in 10 people. Over 50% of individuals with rare disease conditions are children, which means that over 200 million children in the world are currently suffering. It is important to note that over 80% of rare diseases have a genetic disorder as its cause or predisposing factor, which is partially the reason why only about 5% of them have clinically approved treatments.

Although uncommon as a single entity, cumulatively rare diseases have a major impact on the affected population, a profound influence on their quality of life, and are a cause of a significant economic burden.

Please read more about rare disease clinical trials here.

Krill Oil: Can It Protect the Brain from Age-Related Degeneration?

Extensive research has been conducted on Marine oils like fish oil for their health-promoting properties. Much of the research has yet to encompass krill oil, which remains understudied. Krill oil contains long-chain omega-3 fatty acids, antioxidants, and choline, an essential nutrient that aids healthy brain development and function. Researchers examined the effect of krill oil on age-related neurodegeneration and Parkinson’s disease, utilizing a roundworm model to study its effects.

The degeneration of dopaminergic (DA) neurons has been considered critical in Parkinson’s Disease. The study found that krill oil can defend against many neurodegenerative processes in worms and human cell lines. They discovered that krill oil shielded dopaminergic neurons from age-related degeneration and improved cognition.

Dr. Mohebi, the leading researcher, noted that neurodegenerative disorders such as PD or Alzheimer’s advance gradually, and symptoms are only expressed in the later phases of the illness. For example, motor symptoms do not arise in PD until over 80% of DA neurons are gone.

For more information about the study, please follow the link.

New Evidence Links Healthy Plant-Based Diets with Lower Colorectal Cancer Risk in Men

In the United States, colorectal cancer is the third most diagnosed and the second most lethal cancer. While the incidence in older adults has started to decline, it is rising among younger individuals, which may, in part, be due to more effective and widespread screening methods. The risk factors for developing colorectal cancer include being overweight or obese, smoking, and eating a diet containing large amounts of red or processed meats.

The results of a large study that followed 79,952 men and 93,475 women for an average of 19.2 years was just published. It enrolled the participants between the ages of 45 and 75 years who were of African American, Japanese American, Native Hawaiian, Latinx, and Caucasian backgrounds.

The outcomes from the investigation indicate that overall plant-based diets, particularly healthy plant-based diets, were associated with a decreased risk of colorectal cancer in men but not women. The inverse association for healthy diet was stronger in Japanese American, Native Hawaiian, and Caucasian than in African American or Latinx men.

For more information about the trial, please follow the link.

Mortality Associated with Influenza and Respiratory Syncytial Virus in the US

The dramatic spike in RSV and Influenza cases has become a subject of significant concern both in the US and worldwide. Pediatric hospital and ICU beds are overflowing with previously healthy children. One of the hypotheses is that 2 years of COVID-19 isolation practices have led to decreased natural immunity towards common respiratory pathogens.

A new and very timely study published in JAMA evaluated mortality from RSV and Influenza between 1999 and 2018 and suggests that RSV poses a greater risk than influenza to infants, while both are associated with substantial mortality among elderly individuals. Influenza has large interannual variability, affecting different age groups depending on the circulating virus.

For more information about the study, please follow the link.

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