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

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 ; B. Faris ; S. Morley ; L.E. Rhodes ; H. Moseley ; 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.

01 Jul 2009·Lasers in Surgery and MedicineQ2 · MEDICINE

Optimization of topical photodynamic therapy with 3,7‐bis(di‐n‐butylamino)phenothiazin‐5‐ium bromide for cutaneous leishmaniasis

Q2 · MEDICINE

Article

Author: Tayyaba Hasan ; Sebastian X. Lukjan ; Wajeeha Yousaf ; Oleg E. Akilov ; Sarika Verma

AbstractBackground and ObjectivePhotodynamic therapy (PDT) has evolved as a promising therapeutic measure for the treatment of cutaneous leishmaniasis (CL). In particular, phenothiazine compounds have demonstrated efficacy for PDT of CL. The objective of our present study is to define the use of a new specific phenothiazine photosensitizer, 3,7‐bis(di‐n‐butylamino)phenothiazin‐5‐ium bromide (PPA904) applied topically as a cream to treat CL.Materials and MethodsTo establish the optimal conditions for this treatment, we compared two different ways to improve current regimens of PDT with PPA904 cream (500 µM of PPA904 in Unguentum M) by changing the duration of topical application, and by administration of several consecutive PDT procedures. An initial regimen recommended by the manufacturer (Photopharmica Co. Ltd., Leeds, UK) was maintained as a control: the cream was applied topically for 30 minutes at a final concentration of PPA904 at 500 µM, and the designated treatment area was irradiated with a broad band light source of 665±15 nm at a fluence of 50 J/cm2 (50 mW/cm2).ResultsThe best curative PPA904‐PDT regimen was achieved under the conditions of a longer duration of topical application time (90 minutes) and several (three) consecutive treatments with 4‐day intervals between treatments. The mechanisms responsible for such improvements (kinetics of drug penetration, depth of necrosis of the CL lesions after PDT, and daily changes in the parasitic load after PDT) are discussed in the present study.ConclusionTopical PPA904‐PDT, implemented as described above, is a promising treatment for CL, and clinical studies will be initiated to establish efficacy in humans. Lasers Surg. Med. 41:358–365, 2009. © 2009 Wiley‐Liss, Inc.

01 Oct 2007·Photochemical & Photobiological SciencesQ3 · CHEMISTRY

Photodynamic therapy for cutaneous leishmaniasis: the effectiveness of topical phenothiaziniums in parasite eradication and Th1 immune response stimulation

Q3 · CHEMISTRY

Article

Author: Katie O'Riordan ; Tayyaba Hasan ; Sachiko Kosaka ; Oleg E. Akilov

Photodynamic therapy (PDT) is emerging as a therapeutic modality in the clinical management of cutaneous leishmaniasis (CL). The efficacy of PDT against CL has been demonstrated previously with aminolevulinic acid, although the prolonged terms of therapy were less than ideal, and the search for new photosensitizers (PS) is ongoing. However, phenothiaziniums have demonstrated high parasiticidal effects in vitro. The subject of our investigation is the in vivo activity of two PS, 5-ethylamino-9-diethylaminobenzo[a]phenoselenazinium chloride (EtNBSe) and (3,7-Bis(N,N-dibutylamino) phenothiazinium bromide (PPA904). The results of our comparative analysis of the efficacy of these two phenothiazinium analogues demonstrated a high antiparasitic activity of EtNBSe in vitro, and the higher efficacy of PPA904 in a mouse model of CL. The kinetics of photodestruction are different in parasite and mammalian cells, and with both dyes, the macrophages are more susceptible to photodynamic effects than L. major parasites. As the number of parasites in the lesions undergoes a biphasic change, temporarily increasing on days 2-4 and decreasing on days 5-7, more than one treatment is required within an interval of 5 to 7 days. We have also shown that PPA904-PDT can provide an immunomodulating, dose-dependent efflux on IL-12p70 production. This mechanism could be responsible for promoting a more rapid healing in PPA904-PDT treated mice. Our initial data indicate that phenothiaziniums exhibit a high parasiticidal effect in vivo against CL; this finding may be of use in establishing curative PDT regimens for future clinical trials.

100 Deals associated with PPA-904

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Actinic Keratosis	Phase 3	DE	Biofrontera Bioscience GmbH	01 Oct 2013
Leg Ulcer	Phase 3	GB	Photopharmica Ltd.	01 Jan 2009
Wounds and Injuries	Phase 3	GB	Photopharmica Ltd.	01 Jan 2009
Diabetic Foot	Phase 3	-	Photopharmica Ltd.	-

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