"Getting from lab bench to clinic: CMC and practical considerations for phage products"
SAN DIEGO--(BUSINESS WIRE)--AmpliPhi Biosciences Corporation (NYSE MKT: APHB), a global leader in the development of therapies to treat drug-resistant infections using bacteriophage-based technology, announces that it has been invited to present at a workshop entitled “Bacteriophage Therapy: Scientific and Regulatory Issues” being held July 10-11, 2017 in Rockville, MD. This workshop is being organized by the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research and the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases. Further information on the workshop is available from the FDA’s website, here.
This public workshop is expected to bring together an international group of government agencies, academia, industry and other stakeholders involved in research, development and regulation of bacteriophages intended for therapeutic use in humans. The aims of the workshop are to discuss the scientific and regulatory considerations for bacteriophage therapies and to provide a forum for the exchange of information and perspectives, with the ultimate goal of facilitating development and rigorous clinical assessment of bacteriophage therapy products. AmpliPhi also participated in the NIH’s first workshop on bacteriophage therapy in July 2015.
AmpliPhi’s Senior Scientist Susan Lehman, Ph.D., will deliver a presentation entitled “Getting from lab bench to clinic: CMC and practical considerations for phage products” on July 10, 2017, as part of an afternoon session focused on the principal regulatory issues affecting the development of bacteriophage therapy. Dr. Lehman’s presentation will be available following the workshop under the company’s Events & Presentation page.
Bacteriophages, or more simply “phages,” are the natural predators of bacteria and are thought to be the most abundant life form on earth. Phages have evolved an incredible diversity of strains that typically prey upon just a few closely related strains or species of bacteria, enabling phage therapies to precisely target pathogenic bacteria while sparing the beneficial microbiota. Phages can infect and kill bacteria, whether they are antibiotic-resistant or not, and even when they have formed protective biofilms.
About AmpliPhi Biosciences
AmpliPhi Biosciences Corporation is a biotechnology company pioneering the development of therapies for antibiotic-resistant infections using bacteriophage-based technology. In May 2017, AmpliPhi announced an additional near-term strategic emphasis on developing precisely targeted and personalized bacteriophage therapies for patients with serious or life-threatening antibiotic-resistant infections. AmpliPhi has reported results from two Phase 1 clinical trials of AB-SA01, one for the treatment of Staphylococcus aureus in patients with chronic rhinosinusitis (safety and preliminary efficacy) and one to evaluate the safety of AB-SA01 when administered topically to the intact skin of healthy adults. AmpliPhi has additional bacteriophage-based preclinical products in development, including for the treatment of Pseudomonas aeruginosa infections. AmpliPhi has received positive feedback from the FDA and UK Medicines and Healthcare products Regulatory Agency (MHRA) on its development plans.
In May 2017, AmpliPhi announced the completion of an underwritten public offering of common stock and common warrants resulting in net proceeds to AmpliPhi of approximately $9.1 million.
More information is available at www.ampliphibio.com.