An interesting piece of news:
From:
Journal of Wound Care, Vol. 18, Iss. 6 , 01 Jun 2009, pp 237 - 243
D.D. Rhoads, R.D. Wolcott, M.A. Kuskowski, B.M. Wolcott, L.S. Ward, A. Sulakvelidze
Objective: This phase 1 trial set out to examine the safety of a bacteriophage based preparation for difficult to treat wounds.
Method: The intention to treat sample comprised 42 patients with chronic venous leg ulcers (VLUs); 39 patients completed the trial. The ulcers were treated for 12 weeks with either a saline control or bacteriophages targeted against Pseudomonas aeruginosa, Staphylococcus aureus and Escherichia coli. Follow-up continued until
week 24.
Results: No adverse events were attributed to the study product. No significant difference (p>0.05) was determined between the test and control groups for frequency of adverse events, rate of healing, or frequency of healing.
Conclusion: This study found no safety concerns with the bacteriophage treatment. Efficacy of the preparation will need to be evaluated in a phase II efficacy study.
Declaration of interest: One of the authors (AS) holds an equity interest in Intralytix. The other authors do not have any interest in commercial activities.
Study Phase
These phases are defined by the Food and Drug Administration (FDA) in the Code of Federal Regulations.
Most clinical trials are designated as phase I, II, III, or IV, based on the type of questions that study is seeking to answer:
Phase I
In Phase I clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase II
In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
Phase III
In Phase III clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase IV
In Phase IV clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
From Clinical Trials.gov.:
"A Prospective, Randomized, Double-Blind Controlled Study of WPP-201 for the Safety and Efficacy of Treatment of Venous Leg Ulcers"
Sponsored by: Southwest Regional Wound Care Center
ClinicalTrials.gov- Identifier: NCT00663091
Phase I : completed (April 14, 2009 )
Drug: Bacteriophage
WPP-201 is a pH neutral, polyvalent phage preparation, which contains 8 bacteriophages ("component bacteriophages" or "component phages") lytic for P. aeruginosa, S. aureus, and (Table 1). The E. coli cocktail contains a concentration of approximately 1 x 10^9 PFU/ml of each of the component monophages. The phage component of WPP-201 is roughly estimated to be 0.5 ppm by weight and the remainder is phosphate-buffered saline containing < 1,000 ppm total organic carbon from the growth medium and biomass. All phages contained in the preparation have been originally isolated from the environment, and they have not been genetically manipulated in any way (i.e., the preparation is 100% natural). WPP-201 contains no preservatives and antioxidants.
