Clinical study: can a protein derived from breastmilk palliate symptoms of inflammation in the elderly?

Through the process of natural selection, the components of mammalian breastmilk have been shaped over the course of millions of years. For each species of mammal, breastmilk provides not only the nutrients that neonates and infants require for proper growth and development outside of the womb, but also a host of components that protect the newborn mammal from disease, and influence the health and development of the immune system and the gut lining in preparation for independent feeding. Interestingly, recent research suggests that certain individual, protein components of human breastmilk can be beneficial to the health of older human children and even adults, as well as nursing infants or toddlers. However, the ethical, logistic, and safety hurdles involved in sourcing and preparing these proteins from natural sources has limited their practical uses.

Ventria Bioscience has developed a solution to these limitations with the ExpressTec platform for high-yield, plant-based recombinant protein expression. Using ExpressTec rice, Ventria Bioscience can produce recombinant versions of human breastmilk proteins in commercial-scale quantities. Ventria Bioscience is developing several of these proteins for therapeutic use in reducing the downstream effects of chronic inflammation, inflammatory bowel disease, and infectious enteric diseases.

In pursuit of these goals, Ventria Bioscience is currently engaged in an active clinical research collaboration with investigators at the Johns Hopkins School of Medicine. Jeremy Walston MD and colleagues are conducting a phase 2, randomized, controlled clinical trial, Effects of rhLactoferrin on Chronic Inflammation in the Elderly (ELCIE),  which is designed to investigate how recombinant human lactoferrin (rhLactoferrin) produced and purified from ExpressTec rice grains may improve mobility and memory versus placebo in up adults with chronic inflammation.

Dr. Watson’s team will look at the effect of rhLactoferrin on serum levels of IL-6 and TNFR (markers of inflammation). The secondary outcome measures include assessments of cognitive decline and physical mobility as well as tolerability and adherence to treatment.

The study is currently recruiting participants aged 70 years or older. Visit the study page for complete information about the study and contact information.