Sunday, 12 July 2009
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.
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.
