Cole’s initial encounter with phage therapy helped her overcome a blood infection that had resisted various antibiotics for almost a month. After just a day of phage therapy, her infection disappeared as if she were cured. However, a month later, her infection came back. The researchers thus sought another phage that could fight the Enterococcus bacteria causing her infection and introduced both phages. This strategy appeared successful, for she remained infection-free for four months, long enough to leave the hospital and enjoy a holiday with her family. Sadly, her infection came back yet again, and having exhausted all other avenues, she was put into hospice care. Seven months later, she succumbed to pneumonia.
The research team, led by Van Tyne, has spent multiple years trying to figure out why their phage therapy did not successfully ward off the infection permanently. They propose the idea that her body developed antibodies against both the phages two weeks after the second phage was introduced, which could have obstructed the phages’ capacity to identify and eliminate their bacterial targets.
Van Tyne and her team from the University of Pittsburgh have treated other patients as well since she established her lab in 2018. Here, they have accumulated a library of nearly 200 phages, majority of which were derived from local wastewater. They target six to seven bacteria species and constantly strive to develop bespoke therapies for patients with severe infections by aligning clinical evidences from patient infections with the corresponding active phages.
The collective team has treated almost 20 patients so far, with varying degrees of success. Some have effectively overcome their infections, others, like Cole, have shown transient improvements, yet some have not responded to the treatment at all. However, there have been no reported adverse effects from the phage therapy.
Patients have been treated via the FDA’s “compassionate use” program, which allows access to experimental therapies for critically ill patients. Even though case studies offer valuable information, they do not pave the way for regulatory approval. For phage therapy to be integrated into mainstream medicine, clinical trials need to be conducted.
Intralytix’s CEO and president, Alexander Sulakvelidze, has been working on creating phage-based products since the 1990s. Born in the Republic of Georgia, where phage therapy is commonly used to treat infections, his experience could prove to be invaluable in advancing the field.
