Source/Disclosures
Disclosures: Aslam reports receiving grant funding from the Mallory Smith Legacy Fund and the Cystic Fibrosis Foundation and serving as a consultant to Merck outside of this study. Please see the study for all other authors’ relevant financial disclosures.
September 04, 2020
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IV phage therapy shows promise against resistant infections

Source/Disclosures
Disclosures: Aslam reports receiving grant funding from the Mallory Smith Legacy Fund and the Cystic Fibrosis Foundation and serving as a consultant to Merck outside of this study. Please see the study for all other authors’ relevant financial disclosures.
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IV bacteriophage therapy was safe and showed promise against an assortment of infections, according to findings from a case series published in Open Forum Infectious Diseases.

Saima Aslam, MD, MS, an associate professor of medicine at the University of California, San Diego, and infectious disease specialist at UC San Diego Health, and colleagues reviewed the outcomes of the first 10 patients treated with experimental phage therapy on a compassionate use basis at the Center for Innovative Phage Applications and Therapeutics (IPATH), which was created at UC San Diego.

Bacteriophages
IV bacteriophage therapy was safe and feasible for several different types of infections.
Source: Adobe Stock

The patients were not part of an FDA-approved trial of IV phage therapy being conducted by UC San Diego researchers — the first of its kind. That trial is still pending enrollment, Aslam said.

Patients included in this case series “all had failed previous multiple courses of antibiotics for [multidrug-resistant (MDR)] infections, and phage therapy was a last resort effort to treat these infections,” Aslam said.

Aslam and colleagues reviewed IPATH consult requests from June 1, 2018, through April 30, 2020, and assessed the regulatory process of initiating bacteriophage therapy (BT) on a compassionate basis in the United States. They also reviewed the outcomes of the first 10 cases at the IPATH center treated with IV BT from April 1, 2017, onward.

Among 785 BT requests to IPATH, BT was ultimately administered to 17 of 119 patients who were recommended for BT. According to the study, one-third of requests were for Pseudomonas aeruginosa, Staphylococcus aureus and Mycobacterium abscessus.

The study also demonstrated that IV BT was safe, with successful outcomes in seven out of 10 antibiotic “recalcitrant infections” included in the case series. They safely treated six patients with outpatient self-administered BT.

Because phage therapy is still experimental in the U.S., each case required its own FDA approval under single-use investigational new drug applications, Aslam and colleagues said.

“Over the past 2 years, there [has been] a significant interest in evaluating patients with highly MDR infections for phage therapy,” Aslam said. “We noted in this paper, we had almost 800 consults to evaluate patients for phage therapy since the inception of the IPATH.”

Aslam concluded, “Phage therapy is overall safe and is promising as an innovative therapeutic option for MDR infections. Prospective clinical trials are pending at this time.”