First clinical trial for intravenous phage therapy gets FDA approval

A team from the University of California San Diego School of Medicine (CA, USA), in collaboration with biotech company, AmpliPhi Biosciences Corporation (CA, USA), have been given the go ahead for a clinical trial using bacteriophage-based therapy, delivered intravenously, from the US FDA.

The clinical trial will evaluate an experimental bacteriophage, AB-SA01, for treatment of approximately 10 participants, all suffering with resistant Staphylococcus aureus infections in ventricular assist devices (VADs). VADs, electromechanical implants that assist with cardiac pumping for functional circulation, are usually given to patients with heart weakness or failure in need of a transplant. The phage will be given as a combinational therapy with antibiotics.

“There is a high, unmet need in patients with S. aureus VAD infections, which are typically very difficult to eradicate with conventional antibiotic therapy,” commented Saima Aslam, the trial’s principal investigator and medical director of the Solid Organ Transplant Infectious Disease Service at UC San Diego Health.

“In 2018, our UC San Diego Health team treated a patient with a S. aureus VAD infection using AB-SA01 under AmpliPhi’s Expanded Access Program. This clinical trial builds on that foundational work and could provide a much-needed and promising treatment option for this life-threatening condition,” Aslam continued.

In 2017, the successful use of an unprecedented phage therapy was reported. In a desperate last attempt to urgently eradicate a multi-resistant bacterium infecting a dying colleague; the UC San Diego scientists, along with AmpliPhi, were able to successfully cure the patient. This was followed by other stand-alone cases, including another patient who received a much-needed heart transplant after treatment rid them of a bacterial infection that had persisted for years. These, with a few further remarkable cases, led to the opening of the Center for Innovative Phage Applications and Therapeutics (IPATH), in the UC San Diego School of Medicine, the first of its kind in North America. The clinical trial will be IPATH’s first.

“We’re excited to initiate IPATH’s first clinical trial,” concluded Steffanie Strathdee, co-director of IPATH. “And this is just the beginning. This collaboration is one of many we are undertaking to bring phage therapy into the 21st century to combat the global crisis of life-threatening antibiotic-resistant infections.”

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