Photopharmica Reports Positive Results from a Phase 2b Study of Antimicrobial Photodynamic Therapy in the Treatment of Chronic Leg Ulcer Trial
Leeds, UK - 05 October, 2011 - Photopharmica Limited today announces positive results from a Phase 2b randomised, placebo controlled trial of antimicrobial photodynamic therapy using PPA 904 in the treatment of chronic leg ulcers.
The trial successfully met its primary endpoint with statistical significance (p < 0.0001). Antimicrobial photodynamic therapy using PPA 904 was shown to produce a substantial and significant reduction in bacterial load in chronic leg ulcers. The Phase 2B trial was conducted across 11 centres in the UK, with bacterial load measurement carried out centrally to ensure consistency of data.
Significantly fewer PPA 904-treated patients experienced bacterial load levels above the cited threshold for prevention of healing than placebo-treated patients (p=0.0354), encouraging the pursuit of a wound healing claim in a regulatory pivotal trial.
Furthermore, significantly fewer PPA 904-treated patients experienced very high bacterial load levels compared with placebo-treated patients (p=0.0026), suggesting that PPA 904 may reduce the risk of development of clinical infection. All bacterial species investigated were substantially and significantly reduced, including MRSA. A prevention of infection claim in a diabetic foot ulcer indication may also be pursued by conducting further clinical trials based on these findings.
Professor Keith Harding, Head of Wound Healing at Cardiff University Medical School and Chief Investigator on the trial, said: “In 30 years in the field, I have never seen a topical treatment with efficacy anywhere near which PPA has demonstrated. Very few significant advances have been made in this field over the last decade. I believe the PPA technology is the disruptive change needed.”
Photopharmica’s novel antimicrobial proof of principle is relevant to several additional therapeutic areas, including acute surgical wounds and dermatological infections, but also potential therapeutic benefit in the treatment of acne and as an antifungal or antiparasitic medicine.
The Company believes it is now well placed to capitalise on these results and has engaged with pharmaceutical and biotechnology companies searching for acquisition and partnership opportunities.
John Lyon, CEO of Photopharmica, stated: “This result, which shows that the technology kills antibiotic resistant bacteria and is not itself susceptible to resistance, demonstrates a robust proof of principle of the technology and offers the Company a number of pathways to reach the market with its products. At this stage, the Company welcomes approaches from potential co-developers and acquirers – it has reached a valuable and significant point which should generate significant returns once these de-risked products reach their full market potential”.
PricewaterhouseCoopers has been appointed as adviser to the Company.