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.
