18.09.2015 21:00:00

AmpliPhi Announces Data Demonstrating Efficacy of a Novel Bacteriophage Cocktail is Comparable to Vancomycin in S. aureus Lung Infection Model

Ampliphi Biosciences Corporation (NYSEMKT: APHB), a global leader in the development of bacteriophage-based antibacterial therapies to treat drug-resistant infections, today announced experimental results highlighting that its prototype bacteriophage cocktail demonstrated comparable efficacy to vancomycin in reduction of Staphylococcus aureus (S. aureus) in a murine lung infection model. Data from this study, performed in collaboration with the Hearts Consulting Group and the University of North Texas (UNT) Health Science Center, were presented at the joint Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and International Congress of Chemotherapy and Infection (ICC) 2015 meeting, taking place in San Diego from September 17-21.

"We are encouraged by these positive results, which demonstrate comparable efficacy between our investigational bacteriophage therapy and a standard of care therapy like vancomycin for S. aureus infections,” said M. Scott Salka, Chief Executive Officer of AmpliPhi. "These data provide valuable insight as we continue to evaluate and optimize an effective phage-based therapeutic cocktail for combating S. aureus, a potentially lethal bacteria that has demonstrated widespread resistance to traditional antibiotics.”

To assess the in vivo efficacy of bacteriophages to treat lung infections, neutropenic immunocompromised (ICR) mice were inoculated intranasally with S. aureus. At two hours post infection, scaled dosing of the bacteriophage cocktail was administered intranasally to three dosage groups (50 µl; n=5 for each group), with a second identical dose administered at six hours post infection. Vancomycin was administered subcutaneously at two and six hours post infection to a fourth, positive control group. Two control groups were infected, but untreated. The groups treated with the bacteriophage cocktail at the two highest doses (1 x 109 and 1 x 108 PFU per phage per dose) showed a 3-log reduction in bacterial cell counts relative to untreated controls at the same time point, which was comparable to the efficacy seen in the positive control group treated with vancomycin.

"These results further validate bacteriophage therapy as a potential solution for treating bacterial infections and represent an instrumental step in determining optimal dosage levels,” added Salka. "S. aureus is a common, hospital-acquired opportunistic pathogen that can cause serious, and sometimes antibiotic-resistant, infections. Combatting this unmet medical need will improve patient outcomes and alleviate an enormous burden on the global healthcare system. The need for alternative treatments for drug-resistant infections has never been more evident. It is critical that we continue to investigate novel antibacterials and accelerate their development and commercialization.”

The poster presented by AmpliPhi will be available on the Company’s website at www.ampliphibio.com.

About AmpliPhi Biosciences

AmpliPhi Biosciences Corporation (NYSEMKT: 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. For more information, visit www.ampliphibio.com.

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 defense 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, 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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