October 1, 2008 (Vol. 28, No. 17)

Phage International Utilizes Customized Protocols to Infect and Kill Bacterial Infections

As a solution to the problem of antibiotic resistance, Phage International is looking back in history to a forgotten therapy based on bacteriophages. These natural viruses, also known as phages, specifically infect and kill target bacteria. Soldiers with dysentery during World War I were successfully treated with phages, and these bacteria-eating viruses were an antidote for cholera in India in the 1920s.

The discovery of antibiotics dampened enthusiasm for phage therapy in Western countries, but they remained the primary way for treating infections in the Soviet Union. During Stalin’s reign, microbiologist Giorgi Eliava founded the Eliava Institute of Bacteriophage, Microbiology, and Virology (EIBMV) in Tbilisi, Georgia, where people from around the world still come for phage therapy.

“No organization in the world has a phage collection that comes close in efficacy and coverage of strains as the Eliava Institute,” says Christopher Smith, founder, president, and CEO of Phage International in San Ramon, CA.

In 2003, scientists at EIBMV formed a company, Phage Therapy Center, now owned by Phage International. The clinic has a track record of developing phage protocols to treat chronic conditions like sinusitis, urinary tract infections, prostatitis, methicillin-resistant Staph infections, and nonhealing wounds. The phage preparations used at the clinic, sometimes in conjunction with other natural products, are developed at EIBMV.

Smith experienced the power of phage therapy firsthand when he and his wife traveled to Georgia to adopt a baby in 2003. The baby contracted a Staph infection that was cured readily with phage therapy, rather than antibiotics. For the next year, Smith evaluated the scientific potential of phages and talked with phage experts worldwide before launching Phage International in March 2004.

Phage therapy offers many advantages over traditional antibiotics: Phages attack only one type of bacteria, leaving mammalian cells and beneficial bacteria intact. As bacteria evolve to resist treatment, phages evolve right along with them. For every known bacterial strain, there are multiple phages that destroy it. Despite these benefits, phage therapy comes with disadvantages too.

Each phage cocktail is designed to match regional strains of bacteria for different infections in different parts of the body. EIBMV scientists test the sensitivity of phages to dominant strains of bacteria every six months. “Then they update the cocktail by adding new phages or removing old ones to attack newly emerging strains,” says Smith.

This presents a major hurdle for companies in the U.S. because the FDA classifies phages as drugs. Consequently, each individual phage and mixture must be proven safe and effective in separate clinical trials. Also, phages are natural entities that cannot be patented, raising the question of how to turn a profit on phage therapy.

Customized Antibiotic Therapy

Phage International cannot import the phage cocktails and protocols from EIBMV since they are designed to work against local strains of pathogens. When patients from the U.S., Canada, and other foreign countries travel to Tbilisi for treatment, the infecting bacteria are screened so EIBMV can find phages in its library to destroy them.

“They are the only place in the world that performs this type of customized antibiotic therapy,” says Smith. Moreover, the Georgian government will not allow the phages to be exported. Phage therapy has a narrow spectrum of activity, and cocktails must be tuned to the strains in a given geographic region. If distributed worldwide, they likely would not be effective.

The long-term goal at Phage International is to set up clinics in the U.S., Canada, and other countries where customized phage therapies will be developed against local pathogens. Funding has been hard to obtain, and it’s getting even harder as antibiotic resistance lures bigger companies into exploring phages.

Although single phages cannot be patented, Phage International plans to patent phage cocktails, adjunctive treatments, and improved delivery methods like a time-release technology. At the Phage Therapy Center, the cocktails are given orally or topically, such as soaking bandages with a preparation.

The future economic success of phage therapy may depend on how they are classified. As a drug, companies face uphill regulatory challenges. But phages may be promoted as probiotics and administered by naturopaths. Or the FDA could revise its rules and treat phages like the influenza vaccine, which is changed yearly to address current influenza strains, yet does not require clinical trials of each revision.

“As antibiotic resistance becomes a bigger problem, the FDA may need to consider a new category for treatments like phages,” says Smith. Phage therapy may be accepted more easily in countries with lower regulatory hurdles than the U.S.

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