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Clinical Trials

Date: 2016-07-18

Type of information: Presentation of results at a congress

phase: preclinical

Announcement: presentation of results at the Viruses of Microbes 2016 conference held in Liverpool

Company: AmpliPhi BioSciences (USA - VA)

Product: AB-PA01 - AmpliPhage-001 (Pseudomonas aeruginosa bacteriophages)

Action mechanism:

bacteriophage

Disease: Pseudomonas aeruginosa infections

Therapeutic area: Infectious diseases - Rare diseases

Country:

Trial details:

Latest news:

* On July 18-22, 2016, AmpliPhi’s senior scientist Susan Lehman, Ph.D., presented a poster titled ‘Bacteriophage therapy for the treatment of P. aeruginosa infections in cystic fibrosis patients’, which described the in vitro and in vivo activity of phage cocktail AB-PA01. Results showed that AB-PA01 is active in vitro against 87.2% of the 429 clinical isolates tested, including multi-drug resistant as well as sensitive strains of Pseudomonas aeruginosa. The cocktail also survived nebulization with minimal titer loss using five different delivery devices, demonstrating that multiple effective and patient-friendly options are available to pair with the cocktail. 

* On June 12, 2015, AmpliPhi BioSciences announced that new data on the activity of P. aeruginosa bacteriophages after exposure to nebulizer systems applicable for use in future clinical trials have been presented at the European Cystic Fibrosis Conference, taking place in Brussels, Belgium from June 10-13. These new data demonstrated that bacteriophages remain active against Pseudomonas aeruginosa (P. aeruginosa) after nebulization. To determine if nebulization might provide a viable delivery option for AmpliPhage-001, AmpliPhi's program targeting P. aeruginosa infections in Cystic Fibrosis (CF) patients, researchers evaluated the biological activity of four different bacteriophages after nebulization through three commercially available nebulizers. Phages were collected downstream and their biological activity post-nebulization assessed in a standard plaque assay using two P. aeruginosa indicator strains. Phages exposed to non-functioning nebulizer chambers were used as controls. The results showed that all four anti-P. aeruginosa bacteriophages retained their biological activity through all of the nebulizers tested and minor titre drops were within variability of the methodology, confirming that this mode of administration may therefore be appropriate for future clinical trials. The research teams had previously established the safety and efficacy of nasally-inhaled bacteriophage against P. aeruginosa in a murine model, noting reduced infective burden and inflammatory response demonstrated in bronchoalveolar lavage. Based on these positive data, AmpliPhi plans to advance its AmpliPhage-001 program, with delivery via nebulization, towards human clinical trials anticipated to commence in 2016.

Is general: Yes