FDA Approves Bacteriophage Trial
jamanetwork.com - Rebecca Voelker, For Authors
The first US clinical trial of intravenously administered bacteriophage therapy has received FDA approval. Physician researchers at the University of California San Diego (UCSD) School of Medicine will conduct the trial in collaboration with AmpliPhi Biosciences Corporation, a San Diego–based biotechnology company.
Thomas Deerinck/National Center for Microscopy and Imaging Research/UC San Diego
Bacteriophages are viruses that feed on bacteria. Their clinical use as infectious disease fighters dates back to the early 1900s, but they fell out of favor a few decades later when antibiotics arrived. Now, with multidrug-resistant infections on the rise, bacteriophages are garnering new attention.
The proposed phase 1 and 2 trial will evaluate the safety, tolerability, and efficacy of an experimental bacteriophage therapy for patients with ventricular assist devices (VAD) who have developed Staphylococcus aureus infections. The therapy will include antibiotic treatment. About 10 patients will be enrolled in the trial.
“There is a high, unmet need in patients with S aureus VAD infections, which are typically very difficult to eradicate with conventional antibiotic therapy,” principal investigator Saima Aslam, MD, medical director of the Solid Organ Transplant Infectious Disease Service at UC San Diego Health, said in a statement.
Bacteriophage therapy and UCSD made headlines in recent years after a psychiatry professor there, Tom Patterson, PhD, received the treatment for a life-threatening, multidrug-resistant Acinetobacter baumannii infection. The FDA granted emergency approval for Patterson’s treatment. Since then, several other patients also were approved for the therapy.
Largely positive results prompted UCSD to join forces last year with other research institutions and biotechnology companies to launch the Center for Innovative Phage Applications and Therapeutics (IPATH), the first of its kind in North America. The recently approved trial will be the first for IPATH, which was created within the UCSD medical school with a primary goal to conduct rigorous clinical trials of phage therapies.
Source jamanetwork.com