$APHB: AmpliPhi Biosciences Corporation (NYSEMKT:APHB), a global leader in the development of bacteriophage-based antibacterial therapies to treat drug-resistant infections, today announced it has dosed the first patient in its Phase 1 clinical trial to evaluate the safety of AB-SA01, AmpliPhi's proprietary phage cocktail targeting Staphylococcus aureus (S. aureus) infections, administered topically to the intact skin of healthy adults. The trial is being conducted under a Collaborative Research and Development Agreement with the U.S. Army and at the Walter Reed Army Institute of Research Clinical Trials Center in Silver Spring, Maryland.
S. aureus is a leading cause of skin and soft tissue infections, especially among individuals with underlying health conditions. Despite vigorous eradication efforts, S. aureus is common in hospitals where it can plague patients with weakened immune systems, burns and surgical wounds.
The double-blind, ascending dose study is designed to evaluate the safety of AB-SA01 administered topically to the skin of up to six healthy adult volunteers between the ages of 18 and 60 years in each of two dose cohorts. Participants in the low- and high-dose cohorts will receive either 1 x 10(8)or 1 x 10(9)PFU/mL of AB-SA01, respectively, administered topically to the forearm with an occlusive bandage. Placebo will be administered to the opposite forearm, allowing each participant to serve as his or her own control. Participants will receive AB-SA01 and placebo daily for three consecutive days and will be followed for 10-14 days after the final treatment.
"This trial is the important first step in the clinical development of AB-SA01, which we we feel has the potential to be an important weapon against antibiotic-resistant S. aureus infections," said M. Scott Salka, CEO of AmpliPhi Biosciences. "Harnessing the natural predators of bacteria to conquer infections is a radically new therapeutic strategy that has the potential to deliver a new generation of medicines to treat antibiotic-resistant infections, and to do so without destroying a patient's microbiome, or the trillions of beneficial bacteria critical to good health. Our preclinical data demonstrate that AB-SA01 effectively kills a variety of S. aureus strains, including those resistant to methicillin. I would like to thank Jeffrey Livezey, MD, MSc, MAJ, MC, Deputy Director, Clinical Pharmacology at Walter Reed Army Institute of Research and the Principal Investigator of this study, along with his entire team for their support and hard work. I am extremely proud of the AmpliPhi team and our partners for the accomplishment of starting two clinical trials during the first half of 2016, putting us on track to announce data from both trials later this year."
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. In addition to its AB-SA01 trial to evaluate S. aureus infections, AmpliPhi is currently conducting a Phase 1 clinical trial of AB-SA01 for the treatment of S. aureus in chronic rhinosinusitis patients and 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.
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.
S. aureus is a leading cause of skin and soft tissue infections, especially among individuals with underlying health conditions. Despite vigorous eradication efforts, S. aureus is common in hospitals where it can plague patients with weakened immune systems, burns and surgical wounds.
The double-blind, ascending dose study is designed to evaluate the safety of AB-SA01 administered topically to the skin of up to six healthy adult volunteers between the ages of 18 and 60 years in each of two dose cohorts. Participants in the low- and high-dose cohorts will receive either 1 x 10(8)or 1 x 10(9)PFU/mL of AB-SA01, respectively, administered topically to the forearm with an occlusive bandage. Placebo will be administered to the opposite forearm, allowing each participant to serve as his or her own control. Participants will receive AB-SA01 and placebo daily for three consecutive days and will be followed for 10-14 days after the final treatment.
"This trial is the important first step in the clinical development of AB-SA01, which we we feel has the potential to be an important weapon against antibiotic-resistant S. aureus infections," said M. Scott Salka, CEO of AmpliPhi Biosciences. "Harnessing the natural predators of bacteria to conquer infections is a radically new therapeutic strategy that has the potential to deliver a new generation of medicines to treat antibiotic-resistant infections, and to do so without destroying a patient's microbiome, or the trillions of beneficial bacteria critical to good health. Our preclinical data demonstrate that AB-SA01 effectively kills a variety of S. aureus strains, including those resistant to methicillin. I would like to thank Jeffrey Livezey, MD, MSc, MAJ, MC, Deputy Director, Clinical Pharmacology at Walter Reed Army Institute of Research and the Principal Investigator of this study, along with his entire team for their support and hard work. I am extremely proud of the AmpliPhi team and our partners for the accomplishment of starting two clinical trials during the first half of 2016, putting us on track to announce data from both trials later this year."
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. In addition to its AB-SA01 trial to evaluate S. aureus infections, AmpliPhi is currently conducting a Phase 1 clinical trial of AB-SA01 for the treatment of S. aureus in chronic rhinosinusitis patients and 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.
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.
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