Detailed Information on Publication Record
2022
DUOFAG® and its journey to conquest diabetic foot infections
ŠTVERÁKOVÁ, Dana, Martin BENEŠÍK, Tibor BOTKA, Dominik DOSTÁL, Andrea BUCHTOVÁ et. al.Basic information
Original name
DUOFAG® and its journey to conquest diabetic foot infections
Authors
ŠTVERÁKOVÁ, Dana (203 Czech Republic), Martin BENEŠÍK (203 Czech Republic, belonging to the institution), Tibor BOTKA (203 Czech Republic, belonging to the institution), Dominik DOSTÁL (203 Czech Republic), Andrea BUCHTOVÁ, Milan BUŇATA and Marek MOŠA
Edition
Viruses of Microbes 2022, Guimarães, Portugal, 2022, 2022
Other information
Language
English
Type of outcome
Konferenční abstrakt
Field of Study
10600 1.6 Biological sciences
Country of publisher
Portugal
Confidentiality degree
není předmětem státního či obchodního tajemství
References:
RIV identification code
RIV/00216224:14310/22:00129691
Organization unit
Faculty of Science
Keywords in English
phage therapy; diabetic foot; phage cocktail; Staphylococcus aureus; Pseudomonas aeruginosa
Tags
International impact, Reviewed
Změněno: 4/11/2022 15:07, Mgr. Tibor Botka, Ph.D.
Abstract
V originále
In Czechia, the history of phage therapy research dates back to interwar Czechoslovakia, but currently, phage therapy is almost unavailable there. Over the last decade, MB PHARMA has been working on phage research and has developed the phage cocktail DUOFAG®. This cocktail comprises phages active against Staphylococcus aureus and Pseudomonas aeruginosa. DUOFAG® is intended for diabetic foot infections treatment but has the potential for curing other types of infections too. DUOFAG® comprises two phages active against S. aureus and one phage active against P. aeruginosa. The phages characterized on morphological and genomic levels have their host ranges examined on hundreds of clinical isolates of bacteria. DUOFAG® is manufactured in a Czech GMP-certified facility. Elaborate release testing discussed with the State Institute for Drug Control ensures the quality of DUOFAG®. The stability of phages is evaluated regularly. MB PHARMA has established a seed lot system for phages and propagation bacteria. DUOFAG® was examined in preclinical animal studies. Acute dermal toxicity study on rats and local dermal tolerance study on rabbits confirmed the safety of DUOFAG®. Follow-up preclinical studies focusing on subcutaneous administration of DUOFAG® are currently underway. Single and repeated dose toxicity and toxicokinetics studies of DUOFAG® are performed on rats. According to data from Czech hospitals, S. aureus and P. aeruginosa are the main causative agents of diabetic foot infections. The upcoming clinical evaluation of DUOFAG® focuses on proving the safety, tolerability, and efficiency of multiple doses of DUOFAG® in subjects with infected diabetic foot ulcers. The first cohort of patients will be observed for safety evaluation of DUOFAG®, and possible adverse effects will be monitored. In Cohort 2, the study will continue as a double-blind, randomized add-on study of DUOFAG® vs. placebo. The wound healing rate and the microbiological load will be evaluated.
Links
| NU21J-05-00035, research and development project |
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