Research & Development
AmpliPhi Biosciences Updates Positive Clinical Results for its Expanded Access Programme
18 September 2018 - - US-based biotechnology company AmpliPhi Biosciences Corp. (NYSE American: APHB) has released updated topline clinical results for its ongoing single-patient expanded access programme, the company said.

According to the company, 84% of patients achieved treatment success (physician's assessment) at the end of therapy, defined as complete resolution or significant improvement of baseline signs and symptoms.

AmpliPhi has now provided its investigational bacteriophage therapeutics for a total of 21 patients, at 7 hospitals, with serious or life-threatening infections not responding to antibiotic therapy.

These patients were treated with AB-SA01 or AB-PA01 under single-patient expanded access programs in the US (Emergency INDs per the US Food and Drug Administration) or Australia (Special Access Scheme per the Australian Therapeutic Goods Administration).

This updates the data previously announced by the company on 3 January.

Then, the company said that 15 patients with serious S. aureus infections were treated with AB-SA01 and 6 patients with serious P. aeruginosa infections were treated with AB-PA01.

Infections in the treated patients included bacteremia, native and prosthetic valve endocarditis, recurrent pneumonia, ventilator-associated pneumonia, prosthetic joint infection, ventricular assist device infection, and others.

Over 1,000 bacteriophage doses were administered as part of the expanded access programme

This included 400+ doses of AB-SA01, including 300+ doses administered intravenously. Treatment was well-tolerated in all patients with no treatment related serious adverse events.

It also included 600+ doses of AB-PA01, including 400+ doses administered intravenously. Treatment was well-tolerated in five patients. One patient discontinued treatment due to Grade 1 and 2 adverse events, which resolved within 18 hours. There were no treatment-related SAEs.

Also, 84% (16 out of 19) of patients in the modified intent-to-treat population achieved treatment success at the end of therapy.

Treatment success, as determined by the treating physician, was defined as a complete resolution or significant improvement of baseline signs and symptoms.

mITT population was defined as all patients who met the criteria for clinical diagnosis, whose bacterial isolate was susceptible to phage and who received at least one dose of phage.

AmpliPhi Biosciences is a clinical-stage biotechnology company focused on treating antibiotic-resistant infections using its proprietary bacteriophage-based technology.

The company's lead clinical stage product candidates, AB-SA01 and AB-PA01, target multidrug-resistant Staphylococcus aureus and Pseudomonas aeruginosa, which are included on the WHO's 2017 Priority Pathogens List.

Phage therapeutics are uniquely positioned to address the threat of antibiotic resistance as they can be precisely targeted to kill select bacteria, have a differentiated mechanism of action, can penetrate and disrupt biofilms (a common bacterial defense mechanism against antibiotics), are potentially synergistic with antibiotics and have been shown to restore antibiotic sensitivity to drug-resistant bacteria.

Bacteriophages, or more simply "phages," are the natural predators of bacteria and are thought to be the most abundant life form on earth.


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