SAN DIEGO--(BUSINESS WIRE)--AmpliPhi Biosciences Corporation (NYSE MKT: APHB), a leader in the development of therapies for antibiotic-resistant infections using bacteriophage technology, announces financial results for the three and six months ended June 30, 2017 and business highlights.
“The establishment of the Global Antimicrobial Resistance (AMR) Collaboration Hub at the recent G20 summit in July underscores the importance of the AMR issue for public health,” said Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. “I am excited to be at AmpliPhi where we are pioneering bacteriophage therapies for patients suffering from MDR infections and developing a promising approach to address the AMR threat.
“We are developing our lead therapeutic candidates through an approach to treat individual patients suffering from serious or life-threatening infections who have failed multiple courses of antibiotics and have few or no satisfactory treatment options,” Dr. Grint added. “We expect this strategy to validate the clinical utility of our therapies by early 2018 and position us to initiate further efficacy clinical trials later that year.”
“We are executing on the strategy to provide our therapeutic candidates AB-SA01 and AB-PA01 targeting S. aureus and P. aeruginosa, respectively, to patients under single-patient expanded access guidelines (“compassionate use”),” said Igor P. Bilinsky, Ph.D., AmpliPhi’s Chief Operating Officer. “Our goal remains to treat at least 10 patients by the end of 2017 and additional patients in early 2018. Based on this data set, we plan to define indications and optimal treatment regimens for further development and, in consultation with the FDA and other regulatory agencies, define the potential path to regulatory approval.
“We recently supplied AB-PA01 to a major U.S. teaching hospital for a patient suffering from a life-threatening MDR P. aeruginosa lung infection,” added Dr. Bilinsky. “Under an emergency IND allowed by the FDA, multiple doses of AB-PA01 were administered intravenously and by nebulizer. This was the first-in-human administration of AB-PA01, and the treatment was well tolerated. We expect the results to be submitted for presentation at a future medical conference.”
Second Quarter 2017 and Recent Business Highlights
- Appointed Paul C. Grint, M.D. as CEO. Dr. Grint has served as a director of AmpliPhi since November 2015 and has more than two decades of executive leadership experience in biologics and small molecule development, including the successful development and commercialization of anti-infective products.
- Achieved first-in-human dosing of AB-PA01 targeting P. aeruginosa under an emergency IND allowed by the FDA. Multiple doses of AB-PA01 delivered intravenously and by nebulizer were well tolerated.
- Announced positive feedback from an FDA Type B meeting in which the FDA “acknowledged that phage therapy is an exciting approach to treatment of MDR organisms and expressed a commitment to addressing the unique regulatory challenges that might arise during product development.”
- Presented at the two-day “Bacteriophage Therapy: Scientific and Regulatory Issues” workshop sponsored by the FDA and National Institutes of Health. The workshop featured presentations by government, academic, and industry opinion leaders on advancements in bacteriophage technology, clinical case studies and regulatory considerations.
- Presented on the “Adding Tools to the Toolbox: New Technology to Overcome AMR Mechanisms” panel at the 2017 BIO International Convention. Actively participated in the BIO AMR Working Group that advocates for policies to facilitate the development of novel technologies to address MDR infections.
- Announced an oral case presentation at the Centennial Celebration of Bacteriophage Research at the Institut Pasteur in Paris highlighting the successful treatment of a critically ill patient with an MDR Acinetobacter baumannii infection, by Dr. Biswajit Biswas of the U.S. Navy’s Medical Research Center.
Second Quarter Financial Overview
