Some leg ulcers do not seem to respond that well to the standard treatments that we currently use. One reason for this may be that there are high levels of bacteria in the ulcer which may be slowing down the rate of healing. Because we need to be careful about when we use antibiotics, this study will look at another way of killing bacteria in the ulcer. This new method involves putting a special gel on the ulcer and then shining a particular type of light (visible red light) onto the ulcer for a short period of time.
In the first part of the study, a single treatment with the gel and light will be investigated. The second part of the study will compare whether or not using the treatment once a week for 12 weeks is better than placebo.
Across the UK 57 people with chronic leg ulcers will be asked to take part in this study (9 in part 1 and 48 in part 2). Up to 10 sites will be involved including Cardiff University and hospitals in Bradford, Harrogate, Dundee, Hull, Plymouth and the Wirral.
The research is funded by Photopharmica Ltd.

Start Date01 Jan 2009

Sponsor / Collaborator

Photopharmica Ltd.

100 Clinical Results associated with PPA-904

100 Translational Medicine associated with PPA-904

100 Patents (Medical) associated with PPA-904

Literatures (Medical) associated with PPA-904

07 Apr 2023·Nature communicationsQ1 · CROSS-FIELD

Safe drugs with high potential to block malaria transmission revealed by a spleen-mimetic screening.

Q1 · CROSS-FIELD

ArticleOA

Author: Gamo, Francisco Javier ; Tarning, Joel ; Buffet, Pierre ; Ndour, Papa Alioune ; Roussel, Camille ; Dumas, Lucie ; Sissoko, Abdoulaye ; Duez, Julien ; Beher, Babette ; Amireault, Pascal ; Gamallo, Pablo ; McNamara, Case W ; Dussiot, Michael ; Hull, Mitchell V ; Fricot-Monsinjon, Aurélie ; Carucci, Mario ; Sanz, Laura Maria ; García-Barbazán, Irene ; Dao, Ming

Malaria parasites like Plasmodium falciparum multiply in red blood cells (RBC), which are cleared from the bloodstream by the spleen when their deformability is altered. Drug-induced stiffening of Plasmodium falciparum-infected RBC should therefore induce their elimination from the bloodstream. Here, based on this original mechanical approach, we identify safe drugs with strong potential to block the malaria transmission. By screening 13 555 compounds with spleen-mimetic microfilters, we identified 82 that target circulating transmissible form of P. falciparum. NITD609, an orally administered PfATPase inhibitor with known effects on P. falciparum, killed and stiffened transmission stages in vitro at nanomolar concentrations. Short exposures to TD-6450, an orally-administered NS5A hepatitis C virus inhibitor, stiffened transmission parasite stages and killed asexual stages in vitro at high nanomolar concentrations. A Phase 1 study in humans with a primary safety outcome and a secondary pharmacokinetics outcome ( https://clinicaltrials.gov , ID: NCT02022306) showed no severe adverse events either with single or multiple doses. Pharmacokinetic modelling showed that these concentrations can be reached in the plasma of subjects receiving short courses of TD-6450. This physiologically relevant screen identified multiple mechanisms of action, and safe drugs with strong potential as malaria transmission-blocking agents which could be rapidly tested in clinical trials.

01 Apr 2019·Journal of Porphyrins and Phthalocyanines

Update of the situation of clinical photodynamic therapy in Europe in the 2003–2018 period

Author: Mordon, Serge ; Frochot, Céline

Photodynamic therapy has become of interest in many European countries. Since, most of national authorities and all medical journals require the registration of the clinical study on the database ClinicalTrials. gov in order to be published, information regarding clinical studies are now available. This article aims to synthetize data gathered thanks to this database. The keywords used for this analysis was: (i) status: “All studies “(recruiting, completed, terminated, we did not take into account unknown status), (ii) condition or disease: “Photodynamic Therapy”, (iii) country: name of each European country. Since 2003, 76 clinical trials were registered in Europe. Most clinical studies are performed in Germany (22), France (20) and UK (19). These 3 countries represent 80% of all studies performed in Europe. However 21 European countries have one or more studies on PDT. Clinical studies were mainly performed on skin. Actinic Keratosis treatment (20 studies) represents more than 45% of all studies. 21% were focused on eye, mainly on Age Macular Degeneration (AMD) (8 studies). In 2018, ten (10) clinical trials are in the recruitment phase. On November, 10, 2017, Padeliporfin (STEBA Biotech S.A, Luxembourg) obtained the marketing authorization throughout the European Union. Despite the critical importance of trial registration, compliance with requirements from governmental regulators which mandate the prospective registration of clinical trials has been imperfect. Besides, a large proportion of registry entries are never updated to reflect study completion. However, this review clearly demonstrated that PDT is progressively used in most European countries.

01 Mar 2013·British Journal of DermatologyQ1 · MEDICINE

Phase IIa randomized, placebo-controlled study of antimicrobial photodynamic therapy in bacterially colonized, chronic leg ulcers and diabetic foot ulcers: a new approach to antimicrobial therapy

Q1 · MEDICINE

Article

Author: C. O’Grady ; C.L. Lankester ; S.B. Brown ; R.J. Young ; G. Philips ; H. Moseley ; S. Morley ; L.E. Rhodes ; B. Faris ; J. Griffiths ; K. Mellish

BACKGROUNDWith increasing problems of antibiotic resistance, photodynamic therapy (PDT) is being developed as a novel antimicrobial treatment. Following light activation, cationic photosensitizer PPA904 [3,7-bis(N,N-dibutylamino) phenothiazin-5-ium bromide] kills a broad spectrum of bacteria in vitro and this has a variety of potential clinical applications.OBJECTIVESTo determine if PDT in bacterially colonized chronic leg ulcers and chronic diabetic foot ulcers can reduce bacterial load, and potentially lead to accelerated wound healing.METHODSSixteen patients with chronic leg ulcers and 16 patients with diabetic foot ulcers (each eight active treatment/eight placebo) were recruited into a blinded, randomized, placebo-controlled, single-treatment, Phase IIa trial. All patients had ulcer duration > 3 months, bacterially colonized with > 10 colony-forming units cm . After quantitatively assessing pretreatment bacterial load via swabbing, PPA904 or placebo was applied topically to wounds for 15 min, followed immediately by 50 J cm of red light and the wound again sampled for quantitative microbiology. The wound area was measured for up to 3 months following treatment.RESULTSTreatment was well tolerated with no reports of pain or other safety issues. In contrast to placebo, patients on active treatment showed a reduction in bacterial load immediately post-treatment (P < 0·001). After 3 months, 50% (four of eight) of patients with actively treated chronic leg ulcer showed complete healing, compared with 12% (one of eight) of patients on placebo.CONCLUSIONSThis first controlled study of PDT in chronic wounds demonstrated significant reduction in bacterial load. An apparent trend towards wound healing was observed; further study of this aspect with larger patient numbers is indicated.

100 Deals associated with PPA-904

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Indication	Highest Phase	Country/Location	Organization	Date
Actinic Keratosis	Phase 3	Germany	Biofrontera Bioscience GmbH	01 Oct 2013
Leg Ulcer	Phase 3	United Kingdom	Photopharmica Ltd.	01 Jan 2009
Wounds and Injuries	Phase 3	United Kingdom	Photopharmica Ltd.	01 Jan 2009

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