AmpliPhi Announces New Data Demonstrating Anti-Pseudomonal Bacteriophages Retained Biological Activity Following Nebulization

Results presented at the 38th European Cystic Fibrosis Conference

Friday, June 12, 2015 8:00 am EDT



Public Company Information:

"Demonstrating this proof-of-concept represents an important milestone in our AmpliPhage-001 program, as therapeutic administration through nebulization increases the probability that critical areas of the lung can be directly reached with phages in patients with cystic fibrosis."

SAN DIEGO & RICHMOND, Va. & LJUBLJANA, Slovenia & SYDNEY--(BUSINESS WIRE)--AmpliPhi BioSciences Corporation (OTCQB: APHB), a global leader in the development of bacteriophage-based antibacterial therapies to treat drug resistant infections, today announced new data demonstrating that bacteriophages remain active against Pseudomonas aeruginosa (P. aeruginosa) after nebulization. Data from this study, performed in collaboration with the Royal Brompton Hospital and Imperial College, UK, were presented at the 38th European Cystic Fibrosis Conference, taking place in Brussels, Belgium from June 10-13.

To determine if nebulization might provide a viable delivery option for AmpliPhage-001, AmpliPhi's program targeting P. aeruginosa infections in Cystic Fibrosis (CF) patients, researchers evaluated the biological activity of four different bacteriophages after nebulization through three commercially available nebulizers. Phages were collected downstream and their biological activity post-nebulization assessed in a standard plaque assay using two P. aeruginosa indicator strains. Phages exposed to non-functioning nebulizer chambers were used as controls. The results showed that all four anti-P. aeruginosa bacteriophages retained their biological activity through all of the nebulizers tested and minor titre drops were within variability of the methodology, confirming that this mode of administration may therefore be appropriate for future clinical trials.

"We are encouraged by these promising results, indicating that the biological activity of bacteriophage against P. aeruginosa infection is retained following delivery through nebulization," said M. Scott Salka, CEO of AmpliPhi. "Demonstrating this proof-of-concept represents an important milestone in our AmpliPhage-001 program, as therapeutic administration through nebulization increases the probability that critical areas of the lung can be directly reached with phages in patients with cystic fibrosis."

The research teams had previously established the safety and efficacy of nasally-inhaled bacteriophage against P. aeruginosa in a murine model, noting reduced infective burden and inflammatory response demonstrated in bronchoalveolar lavage. Based on these positive data, AmpliPhi plans to advance its AmpliPhage-001 program, with delivery via nebulization, towards human clinical trials anticipated to commence in 2016.

P. aeruginosa infections account for the highest rate of mortality in cystic fibrosis patients, show a high degree of antibiotic resistance and have been historically difficult to treat. Earlier this year, AmpliPhi was granted a European patent covering various bacteriophage preparations for use in combination with antibiotics for the treatment of biofilm-related infections caused by P. aeruginosa.

"Frequent lung infections with high potential for antibiotic resistance are a common comorbidity in cystic fibrosis patients and represent a high unmet medical need with no optimal treatment," continued Mr. Salka. "These data further validate the potential of nebulized phage therapy as a new treatment option for more than 70,000 patients worldwide affected by this debilitating and life threatening disease."

About AmpliPhi BioSciences

AmpliPhi BioSciences Corporation (OTCQB: APHB) is a biotechnology company focused on the development and commercialization of novel bacteriophage-based antibacterial therapeutics. The Company's product development programs target infections that are often resistant to existing antibiotic treatments. AmpliPhi is collaborating with a number of leading organizations, including Intrexon Corporation (NYSE: XON), the U.S. Army, The Royal Brompton Clinic in London, UK and UK-based University of Leicester, to rapidly advance bacteriophage-based therapies.

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About Bacteriophage

Bacteriophage 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. Bacteriophage 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. Bacteriophage 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, including infections in the lungs of cystic fibrosis patients, the ability to deliver bacteriophage-based therapies through nebulization and the development of bacteriophage-based therapies are forward-looking statements subject to risks and uncertainties, including without limitation the risk that the Company will not be able to successfully manufacture sufficient quantities of products to conduct clinical trials or commercialize products in a timely manner or at all, that AmpliPhi may not commence clinical trials or complete IND-enabling studies as expected, that the clinical trials will not be successful, that further development of the Company's products will require extensive and expensive nonclinical 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. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to AmpliPhi's business in general, see AmpliPhi's Annual Report on Form 10-K for the fiscal year ended December 31, 2014, as amended, filed with the Securities and Exchange Commission (SEC) on April 15, 2015.


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