Our Projects
We believe that the Phagebiotics Research Foundation, working
openly in collaboration with researchers here and abroad, can play a key
role in developing models for proceeding with physician-initiated phage
therapy trials in the US and elsewhere that can help move the field
forward to FDA approval in a timely, cost-effective manner. We feel we
can best accomplish this by focusing particularly on the phages that
have been most successful over the last 70 years. These are a group of
phages that target virtually all S. aureus, including MRSA, a major
scourge in both hospital-acquired infections and the broader community.
Diabetic foot infection study
A study we have developed under Podiatrist Randy Fish involves adding phage to the standard treatment of diabetic foot infections where such treatment alone is not working. Preliminary case studies show rapid healing of previously intransigent wounds once phage are added, including an ability to resolve bone infections (osteomyelitis) that have failed all recommended antibiotic treatment. Such wounds are generally treated with amputation, and the successful treatment of such bone infections is in agreement with the results long reported in the Republic of Georgia. The commercial Georgian phage preparation targeting Staphylococcus aureus that is being used is fully characterized and sequenced but not amenable to patent protection due to restrictions on patent protection for prior art (in this case, long therapeutic use). The equally well characterized public-domain Staph phage used as one component in the P.H.A.G.E -directed Belgian burn trial is also available to us for use in wound infection studies.
The poster presentation of this set of case studies of compassionate-care use of phage treatment for diabetic toe osteomyelitis after antibiotic failure has been very well received at several regional and national medical and scientific meetings. At the Academy of Physicians in Wound Healing National Meeting in Philadelphia, it received the Best Poster award. A number of additional presentations and further trials are planned.
While corporations find it challenging to invest in the in-depth clinical trials for such non-patentable yet important phage products, the Veterans Administration and other governmental agencies that fund the care of many diabetic infections and amputees do have the incentive to invest in such a cost-saving addition to conventional care. We are continuing the case studies and refining the protocol for planned double-blind clinical trials. If this approach can indeed be validated, it would represent a major advance in the treatment of diabetic foot infections. The phage-aided cure of such bone infections could greatly reduce the rate of amputation, the associated disability, and the costs for surgery, rehabilitation, and prosthetics associated with limb loss. Additionally, while some of these complicated wounds with and without bone infection do eventually heal with antibiotics, such healing often takes a very long time. Shortening the length of treatment needed to achieve ulcer healing by adding phage therapy to standard care would also greatly reduce disability and cost of diabetic foot ulcer care.
Surgical Infections and Phage Therapy Training Program
To help ensure that the new international explorations of phage therapy benefit from historical clinical experience, we have collaborated with the major Georgian state medical university to establish a certificate program training young Georgian doctors in the techniques developed by experienced surgeons for incorporating phage therapy. In addition to extensive close work with such surgeons, this year-long program includes lectures and discussions on clinical microbiology, pathology, immunology, surgery-related infections, antibacterial therapy, and phage biology. It also includes twice-weekly conversational English classes discussing various clinical issues. This program serves multiple purposes, including the refinement of more precise clinical protocols for formal trials and the focused transfer of clinical experience by the most expert senior surgeons. The incorporation of expert clinicians as teachers is necessary at this point in phage therapy practice, in order to develop protocols for study which are based on the best current clinical knowledge. We believe this cadre of young English-speaking surgeons with in depth training in phage therapy will be a great resource for testing clinical protocols, performing clinical trials in Georgia and helping train surgeons for trials in western countries.
Additional Plans
Develop a collaborative community of clinicians throughout the world to discuss protocols, best practices and compare clinical outcomes.
Support work with the scientists and clinicians at the major international center of phage therapy research and application in Wroclaw, Poland, with whom we are developing a closer relationship.
Collaborate with phage scientists and clinicians worldwide to help develop effective phage preparations, test protocols, agree on best practices and develop the evidence to guide clinical practice.
Diabetic foot infection study
A study we have developed under Podiatrist Randy Fish involves adding phage to the standard treatment of diabetic foot infections where such treatment alone is not working. Preliminary case studies show rapid healing of previously intransigent wounds once phage are added, including an ability to resolve bone infections (osteomyelitis) that have failed all recommended antibiotic treatment. Such wounds are generally treated with amputation, and the successful treatment of such bone infections is in agreement with the results long reported in the Republic of Georgia. The commercial Georgian phage preparation targeting Staphylococcus aureus that is being used is fully characterized and sequenced but not amenable to patent protection due to restrictions on patent protection for prior art (in this case, long therapeutic use). The equally well characterized public-domain Staph phage used as one component in the P.H.A.G.E -directed Belgian burn trial is also available to us for use in wound infection studies.
The poster presentation of this set of case studies of compassionate-care use of phage treatment for diabetic toe osteomyelitis after antibiotic failure has been very well received at several regional and national medical and scientific meetings. At the Academy of Physicians in Wound Healing National Meeting in Philadelphia, it received the Best Poster award. A number of additional presentations and further trials are planned.
While corporations find it challenging to invest in the in-depth clinical trials for such non-patentable yet important phage products, the Veterans Administration and other governmental agencies that fund the care of many diabetic infections and amputees do have the incentive to invest in such a cost-saving addition to conventional care. We are continuing the case studies and refining the protocol for planned double-blind clinical trials. If this approach can indeed be validated, it would represent a major advance in the treatment of diabetic foot infections. The phage-aided cure of such bone infections could greatly reduce the rate of amputation, the associated disability, and the costs for surgery, rehabilitation, and prosthetics associated with limb loss. Additionally, while some of these complicated wounds with and without bone infection do eventually heal with antibiotics, such healing often takes a very long time. Shortening the length of treatment needed to achieve ulcer healing by adding phage therapy to standard care would also greatly reduce disability and cost of diabetic foot ulcer care.
Surgical Infections and Phage Therapy Training Program
To help ensure that the new international explorations of phage therapy benefit from historical clinical experience, we have collaborated with the major Georgian state medical university to establish a certificate program training young Georgian doctors in the techniques developed by experienced surgeons for incorporating phage therapy. In addition to extensive close work with such surgeons, this year-long program includes lectures and discussions on clinical microbiology, pathology, immunology, surgery-related infections, antibacterial therapy, and phage biology. It also includes twice-weekly conversational English classes discussing various clinical issues. This program serves multiple purposes, including the refinement of more precise clinical protocols for formal trials and the focused transfer of clinical experience by the most expert senior surgeons. The incorporation of expert clinicians as teachers is necessary at this point in phage therapy practice, in order to develop protocols for study which are based on the best current clinical knowledge. We believe this cadre of young English-speaking surgeons with in depth training in phage therapy will be a great resource for testing clinical protocols, performing clinical trials in Georgia and helping train surgeons for trials in western countries.
Additional Plans
Develop a collaborative community of clinicians throughout the world to discuss protocols, best practices and compare clinical outcomes.
Support work with the scientists and clinicians at the major international center of phage therapy research and application in Wroclaw, Poland, with whom we are developing a closer relationship.
Collaborate with phage scientists and clinicians worldwide to help develop effective phage preparations, test protocols, agree on best practices and develop the evidence to guide clinical practice.
