Ampliphi Presents Encouraging Pre-Clinical Data on the Use of Phage-Based Therapies to Treat Bacterial Lung Infections

DATA PRESENTED AT THE 26^TH ANNUAL NORTH AMERICAN CYSTIC FIBROSIS ASSOCIATION CONFERENCE, OCT 11-13, ORLANDO, FLORIDA

KEY POINTS

• Research carried out by scientists at AmpliPhi and Institut Pasteur, Paris, with support from the Cystic Fibrosis Association
• In an animal model of acute infection with Pseudomonas aeruginosa a novel therapy comprising a tailored mix of bacteriophage is able to clear respiratory tract infection with efficacy comparable or superior to high dose antibiotics known to be effective in this model (ciprofloxacin)
• The phage-based therapy appears to act faster than the antibiotic and the dissemination of the infection is reduced
• Data suggest that heavily colonized, biofilm-rich environments may provide the optimal conditions for bacteriophage therapy; the cystic fibrosis lung may provide such an environment

RICHMOND, Va. & COLWORTH, England--(BUSINESS WIRE)--AmpliPhi Biosciences Corporation (APHB.PK) [‘AmpliPhi’] presented encouraging data from a pre-clinical animal model study of acute infection with Pseudomonas aeruginosa at the 26^th Annual North America Cystic Fibrosis Foundation Conference held 11-13 October in Florida, USA (NACFC). The data generated in collaboration with scientists at Institut Pasteur in Paris and using AmpliPhi’s phage discovery platform show that the company’s proprietary mix of bacteriophage is able to clear lung infection with efficacy comparable or superior to a high dose of an antibiotic shown to be effective against the infecting bacteria in the laboratory. Furthermore, the bacteriophage therapy rapidly eradicates bacteria in the oropharynx and lungs of the infected mice. In fact, its action appears to be faster than the antibiotic, showing efficacy at just six hours, with reduced dissemination of the infection.

“RATIONAL DESIGN OF A PSEUDOMONAS AERUGINOSA BACTERIOPHAGE THERAPEUTIC AND ITS EFFICACY IN A MURINE LUNG INFECTION MODEL”

Commenting on the study, Philip J Young, CEO of AmpliPhi said: “These results are very encouraging. There is a real need for novel therapies to treat bacterial lung infections. The data show that bacteriophages targeted at P. aeruginosa have potential to be used as alternatives or adjuncts to conventional antibiotics. If clinical efficacy can be established this 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.”

Bacteriophages are naturally occurring viruses that infect bacteria, and only bacteria. Although highly specific for their bacterial hosts, bacteriophages have been identified for a huge range of bacteria. Many bacteriophages rapidly kill their bacterial host, amplifying themselves in the process. Bacteriophages are unaffected by antibiotic resistance and are able to disrupt bacterial biofilms. Antibiotics are most effective against bacteria prior to biofilm formation. Once the biofilm has formed antibiotics are far less effective. Biofilms are a major line of defense for bacteria, contributing to antibiotic resistance. They are a major element in infection of the cystic fibrosis lung. 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 can also restore the efficacy of antibiotics.

The study was designed to test a proprietary phage mix in a respiratory model in mice using luminescent imaging of infection. The work was carried out in order to confirm that the mix of bacteriophages could be effective against an infection with the PAK strain (carrying a luminescent reporter gene; PAK-lumi) of P. aeruginosa in a murine respiratory model. Mice were infected intranasally with P. aeruginosa. The bacteria carried the PAK-lumi reporter gene to express a fluorescent protein, allowing bacterial levels to be quantitated in the mice at time points up to 24 hours. Bacteriophage mixture was delivered to one of three groups of infected mice, the other groups receiving either ciprofloxacin or saline (control). A fourth group was infected but received no subsequent treatment. Infection levels were assessed by luminescence at 24h post-infection.

Young commented further: “These results demonstrate the effectiveness of a phage mix produced using our platform technology. As the evolution of bacteria continues to outpace the existing antibiotics’ ability to eradicate infections their use is becoming less beneficial. We believe that phage will be an important tool in treating acute and chronic infections, especially when biofilms are present as is the case in a majority of chronic lung infections in cystic fibrosis patients.”

Based on these data, AmpliPhi aims to progress phage therapeutics from its discovery and development platform towards a human clinical trial within the next 12-15 months. Examples of bacteriophage compositions demonstrating sound clinical efficacy are very limited. There is therefore a real need to identify improved combinations of bacteriophages for therapeutic use.

AmpliPhi‘s strategy is to develop a targeted pipeline of therapeutics in-house and to secure collaborations with third parties to maximise the potential of its innovative bacteriophage platform technology.

This study was generously supported by the Cystic Fibrosis Foundation Therapeutics Program.

Ends

AmpliPhi Biosciences

AmpliPhi BioSciences Corporation is a biotechnology company dedicated to the development of innovative anti-bacterial solutions to improve human and animal health through the application of its proprietary bacteriophage platform.

AmpliPhi was the first company worldwide to demonstrate the clinical efficacy of bacteriophage technology in a controlled, human clinical trial. It has invested over 15 years into developing phage-based therapies with its lead product BioPhage-PA, a topical treatment for otitis, a chronic inner ear infection, poised to enter Phase III clinical trials in humans. BioPhage-PR, a systemic treatment for lung infections in cystic fibrosis patients in late pre-clinical development and a pipeline of other potential products, including in veterinary medicine and personal hygiene.

For more information, please visit www.ampliphibio.com.

North America Cystic Fibrosis Foundation Conference

The NACFC is the largest gathering of cystic fibrosis professionals in the world and provides superior continuing medical education and a multi-disciplinary approach to the advancement of CF research, treatments and care. The 2012 NACFC was held over three days (11-13 October) and comprised more than 60 scientific and CME (continuing medical education) sessions. It showcased CF-related products and services from more than 45 exhibitors and sponsors. The NACFC was attended by more than 3,500 individuals from all over the world.

AmpliPhi’s presentation on 12 October by CSO D.R. Harper was entitled “RATIONAL DESIGN OF A PSEUDOMONAS AERUGINOSA BACTERIOPHAGE THERAPEUTIC AND ITS EFFICACY IN A MURINE LUNG INFECTION MODEL”. The study was undertaken by K.L. Blake, M.L. McConville, I.M. Prosser, H.M. Parracho, M.C. Enright and D.R. Harper from Ampliphi Biosciences Corp, and M. Henry and L. Debarbieux, Institut Pasteur.

Forward-looking Statements

This press release contains certain forward-looking statements that involve known and unknown risks, delays, uncertainties, and other factors not under the control of the AmpliPhi. AmpliPhi’s actual results, performance, or achievements may differ materially from those conveyed in such forward-looking statements, and AmpliPhi disclaims any intent or obligation to update these forward-looking statements. Examples of such forward looking statements include, but are not limited to, statements about: the potential completion of an acquisition of SPH by AmpliPhi, the potential research, development and commercialization benefits of the potential combination of AmpliPhi and SPH; potential therapies and target indications in both humans and animals that the combined company may research and develop; the benefits of the acquisition of SPH for obtaining additional financing or partnering opportunities; and the number of shares of AmpliPhi that may be issued to the shareholders of SPH in connection with its acquisition by AmpliPhi and the ownership percentage such shares may represent of AmpliPhi’s outstanding shares. The factors that could cause actual results, performance or achievements to differ from the forward-looking statements include the possibility that an insufficient number of SPH shareholders will accept the offer from AmpliPhi to acquire SPH or that the proposed acquisition of SPH by AmpliPhi could otherwise be delayed or prevented; the expected benefits from the AmpliPhi’s acquisition of SPH will not be realized; the risk that the combined businesses will not be integrated successfully; the risk that AmpliPhi’s current financial resources and future financial resources will be insufficient to enable AmpliPhi to fund continuing operations; difficulties or delays in obtaining financing or in entering partnering transactions; and the risk that AmpliPhi’s product research, development and commercialization efforts will be unsuccessful. AmpliPhi is not subject to the reporting obligations of the Securities and Exchange Act of 1934 and, accordingly, is not required to file current or periodic reports with the Securities and Exchange Commission.