 Latest NewsOctober 2011 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. February 2011 Photopharmica is pleased to announce that it has received a notice of allowance of a patent application that covers the Company’s key business areas in USA. This application will proceed to Grant shortly. This application covers antimicrobial photodynamic therapeutic use of a number of key compounds. February 2011 Photopharmica is pleased to note that greater than 75% of the required patients have now been randomised into its phase 2b repeat dose chronic leg ulcer trial. The final data is due Q3 2011. September 2010 Photopharmica is pleased to announce that it has received a notice of grant of a patent application that covers the Company’s key business areas in Canada. September 2010 Photopharmica is pleased to announce that it has received a notice of allowance of a patent application that covers the Company’s key business areas in USA. This application will proceed to Grant shortly. This application covers antimicrobial uses of the Company’s leading candidate plus a number of other candidates. September 2010 Photopharmica is pleased to announce that it has received a notice of grant of a patent application that covers the Company’s key business areas in Europe. This application covers use of the Company’s leading candidate in wound healing. September 2010 Photopharmica is pleased to announce that it has received a notice of grant of a patent application that covers the Company’s key business areas in Japan. April 2010 Photopharmica is pleased to announce that it has received a notice of grant of a patent application that covers the Company’s key business areas in Korea. March 2010 Photopharmica is pleased to announce that recruitment to our Phase IIb chronic leg ulcer trial has now reached the 25% milestone. Interim results are expected Q3 2010. February 2010 Photopharmica has received a Notice of Allowance indication for a USA patent application that covers the Company’s key business areas. This application will proceed to Grant shortly. This application covers pharmaceutical formulations of the Company’s leading candidate. January 2010 Part 2 of Photopharmica’s Phase IIb trial is now ongoing. During this part of the study, subjects will receive 12 weekly applications of PDT with PPA904 and the PPA Lux 680 light source (or placebo). Photopharmica also received MHRA approval to double both light and drug dose. This is the first clinical trial to use repeated PDT treatments and represents a real drive for optimal efficacy. November 2009 Photopharmica is pleased to announce the completion of Part 1 of the Phase IIb clinical trial in chronic leg ulcers. No major safety concerns have been raised and the Data Safety Monitoring Board have recommended progression to Part 2 of the study. July 2009 Infection continues to be a major challenge for healthcare providers, in many medical disciplines. The Health Protection agency have collected surgical site infection statistics (Oct 1997 to Sept 2005) and also in orthopaedic surgery (April 2004 to March 2005). Infection control is an ongoing challenge, an area in which Photopharmica is targeting many of its products. Click here to download PDFs - SSI in England (1471KB) / HPA and Orthopaedic Infection (381KB) May 2009 Photopharmica is pleased to announce the first treatment of a patient in its randomised, placebo controlled, repeat dose Phase II leg ulcer trial with ten centres participating in the trial. This trial builds on the already successful earlier phase II trial, with the enhancements of a proprietary sterile gel formulation, a more suitable light source and a repeat dose regime. April 2009 The Company is pleased to report external validated results carried out in the University of Padova, Italy, which has demonstrated that no bacterial resistance to PPA904 photodynamic therapy has developed, despite sustained attempts in the laboratory to ‘force’ development of resistance. Whilst this was anticipated because the mechanism of antimicrobial PDT means that development of resistance is very unlikely, it is significant that these important new data confirm this. December 2008 Photopharmica received MHRA regulatory approval to commence its repeat dose Phase II leg ulcer trial. Approval was received for both the proprietary formulated drug (PPA 904) and the Company's new proprietary light source (PPA Lux 680) to be used in the upcoming trial. Central Ethics approval was also obtained during December 2008. This upcoming trial seeks to build on the two successful patient trials already concluded in this therapeutic area and continues to enhance PPA 904 with PPA Lux 680 light source as a broad spectrum antimicrobial with accelerated wound healing potential. First patient treatment is scheduled for January 2009. October 2008 Photopharmica is pleased to announce that it has received two Notices of Grant on US patent applications that cover the company’s key business areas. One application covers wound healing applications of the Company’s compounds and the other application covers novel compounds that broaden the portfolio of compounds available for commercialisation. August 2008 Photopharmica is pleased to announce that it has received a Notice of Allowance indication for a Canadian patent application. This application will proceed to Grant shortly. The application covers novel compounds that broaden the portfolio of compounds available for commercialisation. August 2008 Photopharmica is pleased to announce the grant of one of its patent families in Mexico. This patent covers anti-infective use of the Company’s compounds. July 2008 Photopharmica is pleased to announce that it has received two Notice of Allowance indications for USA patent applications that cover the Company’s key business areas. These applications will proceed to Grant shortly. One such application covers wound healing uses of the Company’s compounds and the other application covers novel compounds that broaden the portfolio of compounds available for commercialisation. July 2008 Photopharmica is pleased to announce the grant of two of its patent families in the USA and Europe. These patents cover anti-infective uses of the Company’s compounds and novel compounds for use in PDT, that broaden the portfolio of compounds available for commercialisation.  |
