Industry and Government Involvement in the US
The general awareness and attitude in the US has been changing substantially over the last few years in both scientific and popular circles. At NIH, both Carl Merrill and Sankar Adhya have had substantial interest in phage therapy for a number of years. Merrill in turn inspired Dr. Richard Carlton, who in 1993 formed Exponential Biotherapies -- thefirst American company devoted exclusively to phage therapy work. Its first employees worked in the labs of Merrill and Adhya under a CRADA agreement with NIH, leading to several patents and a very interesting PNAS paper on the selection for long-circulating bacteriophages for therapeutic purposes. In 1993, Exponential rented its own lab space in Rockvillle, MD and hired several additionalemployees. The company focussed initially on vancomycin-resistant enterococcus (VRE), and now has phages in preparation for initial clinical trials. They have also been doing exploratory work related to several other interesting phage therapy applications. Intralytix, a company started in Baltimore in 1998 by Glenn Morris and Alexander Sulakvelidze of the University of Maryland and VA Medical Center,also has a phage approach to VRE ready for initial clinical testing, as well as a treatment for Salmonella in chicken flocks that has the potential to substantially decrease food poisoning problems. Sulakvelidze came to Baltimore from the Georgian Ministry of Health in 1993, and he was instrumental in establishing connections between the University of Maryland and scientists at the Eliava Institutebeginning in 1995. These collaborations have been further enhanced through the founding of Intralytix, which is currently funding projects at the Eliava Institute on phage treatments for Listeria and for Campylobacter. It is also performing the important function of providing dependable electricity for the whole Institute as part of the indirect costs. Intralytix also is working on developing anAmerican version of PhageBioDerm in collaboration with the two scientists who invented it in Tbilisi, and with the help of several visiting Georgian scientists.
The one publicly-listed US company focusing totally on phage therapy is Phage Therapeutics International, started by Canadian venture capitalist Caisey Harlingten in response to the 1996 Scientific American article on phage therapy inTbilisi. Based in Seattle, they have concentrated on antibiotic-resistant staphylococcus, collecting strains from all over the world. They also have phage ready for phase 1 clinical trials - phage that made headlines Sept. 16 1999 with news of a successful compassionate use case in Toronto, involving a woman with Marfan syndrome who had contracted a deadly case of staph during heart surgery. Theclinical trials will be a very expensive hurdle, with the need to prepare each phage in a cocktail separately in the special GMP (Good Manufacturing Practice) facilities required for FDA approval and most manufacturers with GMP capability may be nervous about phage "contamination" of their production facilities. This will, in turn, mean that phage therapy in the West will at least initially berelatively expensive and restricted in scope of applications, without the ability to respond within days with new phages for new pathogens that has been so useful in Tbilisi.
Interest is also growing at NIH. Several years ago, a good deal of educating of an NIH small-business study section was needed to get them to even consider phage therapy proposals as representing a potentially viable alternativeto antibiotics. However, those running the study section were at least interested enough in the concept to include someone with extensive phage experience on the panel. By Feb. 10 2000, NIH released a challenge-grant announcement that specifically called for proposals using phage therapies for emerging and resistant infections, with special focus on vancomycin-resistant enterococci (VRE) and...
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