San Diego and Richmond, VA, USA, Ljubljana, Slovenia, and Sydney, Australia, September 2, 2015 – AmpliPhi Biosciences Corporation (NYSE: APHB), a global leader in developing bacteriophage-based antibacterial therapies to treat drug resistant infections, today announced that Alexander Gaidamaka, Ph.D., D.V.M, has been appointed as the new Vice President of Chemistry, Manufacturing and Control.
Dr. Gaidamaka brings extensive experience to the Company, with over 25 years in the life sciences sector. Prior to his role at AmpliPhi, Alexander served as CEO and CSO of Personalized OncoTherapeutics Inc. He has held executive R&D, product development and quality control roles at Pharma Green LLD, Merial, Sanofi Pasteur, Bioniche Life Sciences Inc. and Biopharm JSC. Dr. Gaidamaka was also previously head of the Department of Immunopharmacology & Allergology at the All-Union Research Institute of Drug Chemistry and Technology, Ukraine. He received a Ph.D. in immunology and microbiology and D.V.M from the Kharkov State Veterinary Academy, Ukraine.
M. Scott Salka, CEO of AmpliPhi Biosciences commented on the appointment: "As we drive our bacteriophage-based pipeline towards clinical development, we are expanding our senior team to add certain critical skills. Alexander brings decades of experience and leadership to his role of overseeing the compliant manufacture and quality assurance of our phage-based therapeutics. We are delighted to welcome Alexander to the team."
In June, AmpliPhi announced that its dedicated bacteriophage manufacturing facility in Ljubljana, was cleared by JAZMP, the Agency of the Republic of Slovenia for Medicinal Products and Medical Devices, to manufacture bacteriophages under current Good Manufacturing Practices (cGMP) standards. AmpliPhi will produce Staphylococcus aureus and Pseudomonas aeruginosa bacteriophages to be used in planned human clinical trials.
AmpliPhi is currently advancing three pre-clinical programs as therapies to treat methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa infections in cystic fibrosis and Clostridium difficile.
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Notes To Editors
About AmpliPhi Biosciences
AmpliPhi Biosciences Corporation (NYSE: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.
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, including infections in biofilms and infections that do not respond to antibiotics, the development of bacteriophage-based therapies and AmpliPhi's clinical, research and development plans are forward looking statements subject to risks and uncertainties, including without limitation the risk that the Company will not be able to 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.