A world first: Pherecydes Pharma launches multicenter clinical study of phage therapy in serious bur - 21/09/2015
For the first time, an industry-standard clinical trial is evaluating the tolerance and effectiveness of phages in fighting sensitive antibiotic-resistant infections
Romainville, France, September 9, 2015 – Pherecydes Pharma, a biotechnology company specialized in the research and development of therapeutic lytic bacteriophages, announces today the launch of the Phagoburn clinical trial. This randomized and monitored phase I/II single-blind trial aims to evaluate the tolerance and effectiveness of two anti-infection bacteriophage treatments in serious burn patients. The effect of the bacteriophages is compared to a reference treatment: silver sulfadiazine.
Phage therapy is an innovative therapeutic method for treating bacterial infections, in particular hospital-acquired infections and/or antibiotic-resistant infections. This is the first international clinical study on phages in the world that meets international standards in clinical evaluation. It will involve 220 patients spread across two arms: 110 patients for each of the two bacteriophages cocktails developed by Pherecydes Pharma. One of the products targets bacterial infections caused by Escherichia coli, the other targets infections caused by Pseudomonas aeruginosa. Infections involving these germs are often very severe. These species frequently and rapidly attain high levels of resistance to antibiotics. This can be fatal if therapy fails. The trial began in July 2015.
Phagoburn is coordinated by the Percy Military Hospital (France), a Service de Santé des Armées (SSA) Hospital within the French Ministry of Defence. It is being conducted in 11 major burns units in France, Switzerland and Belgium. Two other military hospitals are involved in the project – the Reine Astrid Hospital in Brussels (Belgium) and the Sainte-Anne Military Hospital in Toulon (France). Eight civilian hospitals are also taking part: the Liège teaching hospital (CHU) and the Grand-Hôpital of Charleroi-Loverval (Belgium), the Vaud CHU (Switzerland), the St. Joseph/St. Luc Hospital in Lyon, the Nantes and Bordeaux CHUs, the Metz-Thionville regional hospital and the Conception hospital in Marseille (France).
Clean Cells, a French pharmaceutical company, carried out the bioproduction of the phages in line with current pharmaceutical good manufacturing practices (GMP). CRO Statitec (France), which is responsible for managing the trial data and statistical aspects, is also participating in the project.
“Infections are the most common cause of mortality in burn patients,” said Dr. Patrick Jault, head of the anesthesia unit at the Percy Hospital and principal investigator for the trial. “Pherecydes’ approach, involving the use of phages, is an interesting one for us because it has the potential to open up a new avenue for therapy to counter antibiotic resistance through the use of a very rigorous procedure. This study is the result of a close collaboration between all of the stakeholders (SMEs, doctors, pharmacists, regulators, politicians etc.), with the goal of providing a common response to a public health issue.”
“The launch of this clinical trial is a big step for Pherecydes Pharma. Phagoburn has received all the necessary authorizations in France, Switzerland and Belgium; a testament to the quality of our phage therapy method and the development work put into the products tested,” said Jérôme Gabard, CEO of Pherecydes Pharma. “Phage therapy is a promising solution to the problem of bacterial resistance. We see our therapy as both an alternative and a supplement to antibiotic treatment.”
The WHO estimates that, in Europe and the United States, hospital-acquired infections (HAIs) affect 4 million and 1.7 million patients respectively. They are responsible for 147,000 and 99,000 direct and indirect fatalities each year. The annual costs incurred are estimated at €7 bn ($7.82bn) in Europe and $6.5bn (€5.82bn) in the United States. The rapid growth of antibiotic resistance means that this is a major public health issue.
Phagoburn is part of a European FP7 project. The study, launched in June 2013 for a period of three years, has received €3.85 million ($4.3 million) in European Union funding. www.phagoburn.eu
Publication - 01/07/2015
François Ravat (Saint-Luc Saint-Joseph), Patrick Jault (Percy) and Jérôme Gabard (Pherecydes Pharma) wrote a scientific article entitled “Bactériophage et phagothérapie : utilisation de virus naturels pour traiter les infections bactériennes - Using Natural Viruses To Treat Bacterial Infections”.
This article was published in the journal Annals of Burn and Fire Disasters, 2015; 23(1):13-20.
French Documentary on FUTUR MAG - ARTE - 07/02/2015
A documentary about Pherecydes Pharma and its products to treat burned patients ( Phagoburn project ) was released February 7, 2015 in Future mag on the Arte channel.
Article in LesEchos.fr - 22/01/2015
The newspaper LesEchos.fr published in January 2015 an article on Pherecydes Pharma and Phagoburn project.
PHOSA Project - 01/01/2015
PHOSA is a French research project to develop a bacteriophage cocktail to fight against osteoarticular bacterial infections caused by Staphylococcus aureus and epidermidis.
Initiated by Pherecydes Pharma , PHOSA is supported by public funding in the 18th call for projects " FUI - Unique Interministerial Fund " and labeled by the competitiveness clusters Medicen and Lyonbiopôle.
Launched on January 1, 2015 for 24 months, the central objective of PHOSA is the development of an effective bacteriophages lytic cocktail against bone and joint infections (IOA ) caused by staphylococci. At the end of the project, the regulatory steps required to launch a clinical trial in humans (phase I / II) for the cocktail should have been conducted .Beyond Pherecydes Pharma , unique French company specialized in the field of phage therapy , the PHOSA Consortium brings together four partners with complementary expertise: two innovative SMEs ( Biofilm Control and Vivexia ) and two public research centers (CHIV and HCL).
Article in Nature ! - 06/06/2014
The newspaper Nature published in June 2014 an article on phage therapy.
New french article about phagotherapy - 27/05/2014
The journal pharmaceutiques published in April 2014 an article about new ways to fight against multidrug-resistant bacteria.
Among others, the article talks about phage therapy and Jérôme Gabard, Pherecydes Pharma CEO, is interviewed.
New articles - 13/01/2014
Two new french articles were published in January 2014 on Phage therapy.
Le Monde and Le Progres (French newspapers) published articles on phage therapy and the Phagoburn project.
Pherecydes Pharma at the European Parliament - 17/09/2013
Dr. Jérôme Gabard (Pherecydes Pharma) took part in a meeting on phage therapy in Brussels on September 17th.
Dr. Jérôme Gabard (Pherecydes Pharma) took part in a meeting on phage therapy organized by the European Deputy Michèle Rivasi (The Greens/European Free Alliance) in Brussels on September 17th, in association with Maryvonne Blondin Senator (PS).
This meeting gathered Dr. Alain Dublanchet, Olivier Patey (Villeneuve Saint Georges Hospital), Patrick Jault (Percy Hospital), Jean-Paul Pirnay and Gilbert Verbeken (Queen Astrid Hospital) key phage therapy actors, looking forward a regulatory proposal in this medical area.
Among others, Dominique Rivasi (General Director of the European Joint Research Center), Guy Van Den Eede(Adviser for BioEconomy of the JRC), Marco Cavaleri (Head of Anti-infectives and Vaccines, European Medicines Agency), Dominique Labbé (Associate Director of Innovative Therapies, Human Derived and Vaccines Direction of the French National Agency for Medicines and Health Products Safety), as well as, Laurent Bretaudeau (Clean Cells) were actively involved in the meeting.
Pherecydes Pharma Present PHAGOBURN at Evergreen - 01/08/2013
The 20th Biennial Evergreen International Phage Meeting will take place at Evergreen (Olympia, WA, USA), from Aug. 4-9, 2013.
Dr. Jérôme Gabard will introduce the project PHAGOBURN: first european clinical study on phage therapy to treat E. coli and P. aeruginosa skin infections in burn wounds. A project supported by the European Union FP7.