RICHMOND, Va. & SYDNEY & LONDON--(BUSINESS WIRE)--AmpliPhi BioSciences Corp. (OTC: APHB) (“AmpliPhi”), the leader in the development of bacteriophage-based antibacterial therapies to treat drug resistant bacterial infections, yesterday presented data relating to the use of bacteriophages in the treatment of Pseudomonas aeruginosa (P. aeruginosa) at the 20th Biennial Evergreen International Phage Meeting held in Olympia, Washington, USA. P. aeruginosa is the major cause of lung infections in cystic fibrosis (CF) patients.
The presentation by Sandra Morales, Head of Research at AmpliPhi, entitled “Phage therapy for the treatment of P. aeruginosa lung infections in Cystic Fibrosis patients”, summarized data from three related studies demonstrating the potential for AmpliPhi’s proprietary bacteriophage mixes in the management of lung infection in CF patients.
“Taken together, these data present a compelling case for the potential of bacteriophages to treat P. aeruginosa infections in CF where the existence of biofilms and multi-drug resistant bacteria are a growing problem,” said Ms. Morales, who is based at AmpliPhi’s facility in Sydney, Australia.
“Biofilms are a major element in infection of the CF lung. Once a biofilm has formed, antibiotics are far less effective. Biofilms are a major line of defence for bacteria, contributing to antibiotic resistance. Bacteriophages are able to penetrate biofilms and replicate locally to high levels, to produce strong local therapeutic effects. Biofilm degradation by bacteriophages kills bacteria and could also potentially restore the efficacy of antibiotics” she added.
The first data set, based on results presented at the 2012 European Congress of Clinical Microbiology and Infectious Diseases conference, showed, in an in vitro model which resembled the environment in the CF lung, that bacteriophages can infect both mucoid and non-mucoid P. aeruginosa strains isolated from CF lungs, whether or not they were antibiotic resistant.
The second study, conducted in collaboration with the Pasteur Institute in Paris, examined a proprietary anti-Pseudomonas bacteriophage mix in the treatment of a murine model of acute lung infection. The bacteriophage mix was shown to be as effective as a known high dose of antibiotic but also appeared to be more effective and faster at preventing the dissemination of the bacteria to lung and oropharynx. This data was presented initially at the 26th Annual North American Cystic Fibrosis Association Conference in 2012.
The third study presented research conducted in collaboration with the Brompton Hospital, London (see - Thorax 2012; 67: A50-A51 http://thorax.bmj.com/content/67/Suppl_2/A50.3) examining the effectiveness of a bacteriophage mix treatment in a murine model to both clear P. aeruginosa infection and limit inflammation. The results demonstrated that the use of bacteriophage helps eliminate the infection earlier, which in consequence results in a lower inflammatory response.
“Our pre-clinical results to date are encouraging. There is a real need for novel therapies to treat bacterial lung infections. Phage mixes targeted at P. aeruginosa have the potential to be used as alternatives or adjuncts to conventional antibiotics. If the synergistic efficacy can be established, bacteriophage-based therapy will be of special importance to cystic fibrosis patients because P. aeruginosa is the most common bacteria that affects the lungs of a CF patient” said Philip J Young, CEO of AmpliPhi, who was also attending the conference.
“Examples of bacteriophage demonstrating clinical efficacy when used in regulated clinical trials are very limited. There is a real need to identify and test improved bacteriophages mixes in controlled clinical trials. We believe our preclinical data is supportive of this move as we plan to initiate clinical trials in 2014” he added.
About AmpliPhi BioSciences
AmpliPhi BioSciences Corporation (OTC: APHB) is a biotechnology company focused on the development and commercialization of novel bacteriophage-based therapeutics for human and animal applications. The Company’s product development programs are targeting Gram-negative infections that are often resistant to existing antibiotic treatments. AmpliPhi was created in 2011 through the merger of BioControl Ltd with Targeted Genetics Inc. and subsequent combination with Special Phage Services in 2012. The Company is US-headquartered in Richmond, Virginia and has operations in London, UK and Sydney, Australia. For more information, visit www.ampliphibio.com
Bacteriophages are naturally occurring viruses that are highly specific for the bacterial hosts they infect. They can rapidly kill their host, amplifying themselves in the process. Bacteriophages are unaffected by antibiotic resistance and are able to disrupt bacterial biofilms. Such biofilms are a major line of defence for bacteria, contributing to antibiotic resistance. Bacteriophages are able to penetrate biofilms and replicate locally to high levels, to produce strong local therapeutic effects.
Forward Looking Statements
Statements in this press release about the potential use of bacteriophages to treat bacterial infections and the development of bacteriophage-based therapies are forward looking statements subject to risks and uncertainties, including without limitation the risk that such therapies may not be successfully developed, will require extensive and expensive pre-clinical and clinical testing, may not be safe or efficacious, and may not be approved for marketing by the United States Food and Drug Administration or any foreign regulatory agency.