SAN DIEGO--(BUSINESS WIRE)--AmpliPhi Biosciences Corporation (NYSEMKT:APHB), a global leader in the development of bacteriophage-based antibacterial therapies to treat drug-resistant infections, today announced that the Japanese Patent Office has granted AmpliPhi a patent for the “Beneficial effects of bacteriophage treatments” targeting Pseudomonas aeruginosa (Pseudomonas) infections. A corresponding patent has been granted in the United States and is currently being prosecuted in Canada. Additional patents with broader bacterial species claims have been granted in the European Union and Australia.
The patent covers the treatment of Pseudomonas infections through the sequential use of a bacteriophage (phage) therapeutic followed by an antibiotic to which the bacteria were formerly resistant. During the first stage of phage administration, antibiotic-resistant Pseudomonas are placed under extreme selective pressure by the attacking phage. Following the initial assault, most of the bacteria die, but a small portion may evade the phage attack by mutating in a way that protects them from the phage but at the same time resensitizes that population to antibiotics. Antibiotics are then administered to deplete the remaining bacterial population. This resensitization phenomenon has been observed in both in vitro and in vivo experiments as well as in a few antibiotic-resistant human infections, including a previously-reported case where an antibiotic-resistant Pseudomonas bladder infection was treated and cleared in Australia under a compassionate use exemption.
Pseudomonas infects almost 60% of cystic fibrosis (CF) patients overall, with approximately 80% of patients over the age of 18 chronically infected by the pathogenic bacteria. Recurrent Pseudomonas infections cause severe lung damage and can lead to bronchiectasis and the need for lung transplants. Current standard of care treatment for CF patients include inhaled antibiotics that tamp down but may not eliminate the infection. AmpliPhi’s investigational drug therapy, AB-PA01, is designed to broadly target both CF and non-CF Pseudomonas isolates and potentially eradicate the infection instead of merely keeping it at bay.
“Through a step-wise treatment paradigm of AB-PA01 followed by antibiotics, we envision a treatment modality that effectively clears chronic Pseudomonas infections in CF patients,” said M. Scott Salka, CEO of AmpliPhi Biosciences. “By resensitizing Pseudomonas to antibiotics, we can turn back the clock on currently ineffective antibiotics and make them relevant again. Antibiotic resensitization has the potential to provide patients and caregivers with a new set of weapons to make impactful progress against the growing threat of antibiotic resistance by combining the natural ability of phage to selectively target bacteria with the current arsenal of antibiotics. We look forward to evaluating our proprietary phage cocktail alongside existing antibiotics to address recurrent and resistant Pseudomonas infections in patients with CF.”
AB-PA01 is currently being manufactured in AmpliPhi’s cGMP facility and is in nonclinical studies at the Royal Brompton Hospital, London, UK. AmpliPhi anticipates initiating a Phase 1 clinical trial in 2017 of AB-PA01 for the treatment of CF using a nebulized formulation of the phage cocktail.
For more information, visit 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. AmpliPhi's product development programs target infections that are often resistant to existing antibiotic treatments. AmpliPhi is currently conducting a Phase 1 clinical trial of AB-SA01 for the treatment of S. aureus in chronic rhinosinusitis patients and another Phase 1 clinical trial to evaluate the safety of AB-SA01 when administered topically to the intact skin of healthy adults. AmpliPhi expects to report final data for both trials in the second half of 2016. AmpliPhi is also developing bacteriophage therapeutics targeting Pseudomonas aeruginosa and Clostridium difficile in collaboration with a number of leading organizations focused on the advancement of bacteriophage-based therapies.
Forward Looking Statements
Statements in this press release that are not statements of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, without limitation, statements about the expected timing of reporting data from AmpliPhi’s two AB-SA01 trials, the expected timing for initiating a clinical trial of AB-PA01, the potential use of bacteriophages to treat bacterial infections, including infections that do not respond to antibiotics, the ability to resensitize antibiotic-resistant bacteria to antibiotics, the potential benefits of phage therapy, and AmpliPhi’s development of bacteriophage-based therapies. Words such as “believe,” “anticipate,” “plan,” “expect,” “intend,” “will,” “may,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based upon AmpliPhi’s current expectations and involve a number of risks and uncertainties, including the risks and uncertainties described in AmpliPhi’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, as filed with the Securities and Exchange Commission. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and AmpliPhi undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.