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Phage Studies in the USA in 2019

 

Two phage clinical trials will launch in the USA in 2019

1. The first trial as a phase 1/2a double-blind, randomized, placebo-controlled trial to assess the safety and efficacy of oral administration of EcoActive on Intestinal Adherent Invasive Escherichia Coli (AIEC) in patients with inactive Crohn's disease. The cause of Crohn's disease is poorly understood. However, the presence of AIEC in the intestines is associated with worsening inflammation in this disease. Inflammation is the presence of redness, irritation, and ulcers in the intestines. By using phages that only infect and kill this specific type of bacteria (AIEC), it is the hope this can be used to improve the course of Crohn's disease. The phages would only target the AIEC, without affecting the natural, often helpful, bacteria of the intestines. EcoActive may also lessen the use of antibiotics to control symptoms. When antibiotics are used, they can have major effects on the rest of the bacteria in the intestines. Also, repeated use can cause intestinal bacteria to become resistant to antibiotics. Reduced use of antibiotics would limit both of these risks.

2. The second phage study will be the first clinical trial for the Center for Innovative Phage Applications and Therapeutics (IPATH) in the UC San Diego School of Medicine, the first such center in North America. It will be a phase I/II clinical trial in which AB-SA01, an experimental bacteriophage combination for the treatment of participants with ventricular assist devices (VADs) infected by resistant Staphylococcus aureus (S. aureus) will be tested. The trial will evaluate the safety, tolerability and efficacy of AB-SA01 bacteriophage therapy in combination with best available antibiotic therapies. There will be approximately 10 participants enrolled. VADs are implantable mechanical pumps that help pump blood in patients with weakened hearts or heart failure. They are sometimes used as a transitional device for patients awaiting a heart transplant.