A medical center for improving phage therapy methods and testing new phage products—The Center for Innovative Phage Applications and Therapeutics (IPATH)—has opened at the University of California, San Diego (USA). This is the first such center in North America.
While in Eastern Europe (Poland, Georgia, Ukraine, Russia, and other countries that emerged after the collapse of the USSR), the use of phage preparations to treat infectious diseases has been continuous since their discovery over a hundred years ago, in Western Europe, the United States, and Canada, phage therapy is rarely used in medicine, and phage preparations are awaiting large-scale clinical trials. The fact that such a reputable medical center will be involved in phage therapy significantly increases the chances of bacteriophages receiving approval from strict US regulatory authorities.
A key motivation for establishing the IPATH center in San Diego was the spread of antibiotic-resistant strains of pathogenic bacteria in the United States, as well as worldwide. However, the center's team also had personal motives. In 2015, their colleague, psychiatrist Tom Patterson, was brought back from Egypt with a severe pancreatic infection. The causative agent turned out to be the bacterium Acinetobacter baumannii , resistant to all available antibiotics, and without appropriate treatment, Patterson fell into a coma. His wife, Stephanie Strasdy, an epidemiologist at the same university, leveraged all her connections to find a bacteriophage that could defeat the infection and save the patient. She obtained various phage strains, administered treatment, and Patterson not only survived but also recovered .
After her husband's "miraculous" recovery, as everyone called it, Stephanie became an ardent advocate for phage therapy and, over the course of two years, helped select effective bacteriophages for five more patients with severe, antibiotic-resistant infections (in the US, drugs that have not undergone FDA approval may be used for treatment in severe cases).
Stephanie Strasdy and Dr. Robert Schooley of the University of California initiated the creation of the IPATH Clinical Center. The center will not manufacture phage preparations itself, but will collaborate with research groups and private companies to conduct multicenter clinical trials of phage therapeutic drugs and regimens.
The IPATH center will initially treat patients with chronic antibiotic-resistant infections associated with organ transplants, implantable devices, or joint replacements, as well as cystic fibrosis.
Previously, the inability to register phage preparations according to standard FDA requirements was a serious problem, as the preparations were individually prepared for each patient. However, a representative of one biotech company producing phage preparations recently stated that the FDA is willing to be flexible, and the company plans to register its entire phage collection (approximately one hundred phage strains for each clinically significant bacterial species) at once.
In addition to conducting large trials, the IPATH center will continue to help select patients with severe infections with bacteriophage treatment.
IPATH News: https://health.ucsd.edu/news/topics/phage-therapy/Pages/Phage-News.aspx
* Can bacteria-slaying viruses defeat antibiotic-resistant infections? A new US clinical center aims to find out (By Kelly Servick) // Science, Jun 21, 2018. doi:10.1126/science.aau5414