Pittsburgh Phage Program (P3)

About the Program

The Pittsburgh Phage Program (P3) is a multi-disciplinary team focused on therapeutic bacteriophages. We are focused on phage discovery, biology, pharmacology, and immunogenicity, as well as the microbial impact of bacteriophages when they are administered to patients infected with multidrug- resistant (MDR) pathogens. We have also established an ethical framework for phage administration through which we provide phages for compassionate use and conduct clinical trials to evaluate the safety, efficacy, and biological properties of phages in humans. Our long-term goal is to create a world-class program in phage therapy that will advance the field of bacteriophage therapy for MDROs into the mainstream.

The Pittsburgh Phage Program was originally organized by i4Kids via Pitt Momentum Funds awarded by the University of Pittsburgh Office of Research with support from the Office of the Provost. The program is currently affiliated with the UPMC Infectious Diseases Expanded Access (IDEA) Center and the Division of Infectious Diseases. We are also supported by the University of Pittsburgh Department of Medicine, UPMC, and extramural grant funding.

About the Program

Phage Therapy Overview

Requesting Phage Therapy

Frequently Asked Questions

Meet the Team

Phage Therapy Overview

What is Phage Therapy?

Phage therapy refers to the use of bacteriophages (phages), which are viruses that infect bacteria but cannot infect or harm human cells, in patients infected with antibiotic-resistant bacterial organisms. Phages are specific to particular bacteria and are considered as potential therapies for serious bacterial infections, especially those caused by antibiotic-resistant pathogens. Phages are considered an investigational biologic product and are still experimental. Although there has been increased study of phage therapy in recent years, no phage therapy product has been approved for sale by the U.S Food and Drug Administration (FDA) as of 2024.

How Phage Therapy Works

Phages infect specific bacteria and replicate inside the infected cells, resulting in bacterial killing. Due to their specificity, different phages are required for different bacterial infections.

Targeting Bacteria at P3

Our phages target several types of bacteria, including:

Pseudomonas aeruginosa
Enterococcus species
Klebsiella pneumoniae
Achromobacter species
Enterobacter species
Stenotrophomonas species
Others

Administration Methods

Phages can be administered intravenously (IV), inhaled, orally, or locally. The choice of route depends on the indication and other variables, although this is also an investigational area. Phage doses must be kept refrigerated and kept away from light until immediately before administration.

Requesting Phage Therapy

How can I access phage therapy?

Patients can gain access to phages through:

Clinical Trials
There are several bacteriophage therapy trials underway evaluating different phages for different infections. Current trials can be found on clinicaltrials.gov (link to search results). For a list of clinical phage trials actively enrolling at UPMC/University of Pittsburgh, please visit our X account @PghPhageProject.

Expanded Access (Compassionate use of phage therapy)
The FDA allows patients with serious or immediately life-threatening diseases or conditions to gain access to an investigational product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

How to request from P3

If you are a physician, please contact P3 at phage@pitt.edu for inquiries.

If you are a UPMC patient, please discuss with your physician who can contact us at phage@pitt.edu.

If you are a NON-UPMC patient, please discuss with your local provider who can contact us at phage@pitt.edu. Phage therapy products manufactured by P3 are administered under the care of your local treating physician. At this time, compassionate use phage therapy for non-UPMC patients cannot be administered at UPMC nor can direct patient care be transferred to UPMC solely for phage therapy outside of a clinical trial.

Process Timeline

This is a personalized medicine product, which requires individualized production. Thus, time to treatment can vary from several weeks to several months.

Financial Considerations

Phages are provided at no cost. However, patients and their insurance(s) are responsible for standard care costs associated with administration and monitoring, as well as any expenses not covered by insurance.

Frequently Asked Questions

What is a phage?

Bacteriophages (phages) are viruses that infect bacteria and do not infect human cells.

Is phage therapy new?

The concept of using phages therapeutically has been around for about 100 years but has recently gained renewed interest due to antibiotic resistance and several successful cases. However, much remains to be learned about

Will phage therapy replace antibiotics?

It is unlikely that phages will replace antibiotics, but phages may be used in combination with antibiotics, or as a treatment for antibiotic-resistant

What are the benefits of phage therapy?

Phages may be an option for treating patients infected with bacteria that are resistant to most antibiotics.

What are the risks of phage therapy?

Side effects have occasionally been reported but have generally been mild and self-limited. Proper preparation of phage therapy is crucial to the safety of phage therapy.
Phages are prepared in the laboratory following strict safety protocols and are tested for sterility prior to administration.
Resistance to phages, similar to antibiotic resistance, is possible. Because phages are viruses, they can elicit an immune response when given to humans (just like a viral vaccine would). However, the significance of the immune response remains unknown, and there is currently no evidence of harm secondary to phage-related immunity.