Phase II Study to Investigate the Properties of Topical Twice Daily Doses of 2.5% and 5% Cis-urocanic Acid in Comparison to Active Comparator 0.1% Protopic® for up to 28 Days in Patients With Moderate or Severe Atopic Dermatitis

The purpose of this study is to evaluate dose response, safety, tolerability and efficacy of 2.5% and 5% cis-UCA in comparison to placebo and active comparator in the treatment of adult patients with moderate or severe chronic atopic dermatitis.

Start Date01 Mar 2011

Sponsor / Collaborator

BioCis Pharma Oy

NCT01458847 / CompletedPhase 1

A Single Dose, Dose-escalating, Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of Intravesical Cis-urocanic Acid (Cis-UCA) in Patients With Primary or Recurrent Non-muscle Invasive Bladder Cancer

The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of intravesical cis-urocanic acid in patients with primary or recurrent non-muscle invasive bladder cancer.

Start Date01 Oct 2009

Sponsor / Collaborator

BioCis Pharma Oy

[+3]

EUCTR2008-008332-90-FI / Not yet recruitingNot Applicable

Double-blind, vehicle-controlled, single centre Phase I/IIa study with topical twice daily doses of 5% cis-urocanic acid to investigate pharmacokinetics, safety, tolerability, and efficacy for up to 28 days in subjects with mild to moderate plaque psoriasis

Start Date10 Feb 2009

Sponsor / Collaborator

BioCis Pharma Oy

100 Clinical Results associated with BioCis Pharma Oy

0 Patents (Medical) associated with BioCis Pharma Oy

Literatures (Medical) associated with BioCis Pharma Oy

01 Dec 2017·Graefe's Archive for Clinical and Experimental OphthalmologyQ3 · MEDICINE

Topical cis-urocanic acid prevents ocular surface irritation in both IgE -independent and -mediated rat model

Q3 · MEDICINE

Article

Author: Laihia, Jarmo ; Oksala, Olli ; Viiri, Johanna ; Jauhonen, Hanna-Mari ; Alajuuma, Päivi ; Sironen, Reijo ; Leino, Lasse ; Kaarniranta, Kai

PURPOSEOur purpose was to investigate the effect of locally administered cis-urocanic (cis-UCA) in two experimental models of allergic conjunctivitis.METHODSThe compound 48/80 (C48/80)-induced ocular irritation model (IgE-independent) and the ovalbumin (OA)-induced ocular allergy model (IgE-mediated) were used to test and compare the effect of cis-UCA on dexamethasone, ketotifen and olopatadine. In the C48/80 model, clinical severity scoring from photographs, immunohistochemical analysis of nuclear Ki-67 antigen to quantify actively proliferating epithelial cells and of caspase-3 enzyme to identify apoptotic activity in the conjunctival tissue were used. In the OA model, an Evans Blue stain concentration of conjunctival tissue was used to evaluate vascular leakage due to allergic reaction.RESULTSThe cis-UCA was well tolerated and effective in both the IgE-independent and -mediated rat models. Treatment with C48/80 caused conjunctival hyperaemia, which was significantly inhibited by ketotifen at the 6 h time point (p = 0.014) and by dexamethasone and cis-UCA 0.5% at 12 (p = 0.004) and 24 (p = 0.004) hour time points. In a comparison between the active drug treatments, only ketotifen showed a significant difference (p = 0.023) to cis-UCA treatment at the 1 h time point, otherwise there were no statistically significant differences between the active drugs. Ketotifen, dexamethasone and cis-UCA 0.5% significantly inhibited the C48/80-induced nuclear accumulation of Ki-67, without differences between the active treatment groups. In the OA model, cis-UCA 0.5% did not inhibit the vascular leakage of conjunctiva, whereas cis-UCA 2.5% of was at least equally effective compared to olopatadine, abolishing the allergic vascular leakage response almost completely.CONCLUSIONSThe present findings in the two AC models suggest that cis-UCA might have anti-allergic potency both in immediate and delayed-type allergic reactions in the eye.

01 Sep 2016·Neurourology and UrodynamicsQ3 · MEDICINE

Intravesical treatment with cis-urocanic acid improves bladder function in rat model of acute bladder inflammation

Q3 · MEDICINE

Article

Author: Streng, Tomi ; Jääskeläinen, Katarina ; Leino, Lasse ; Konkol, Yvonne ; Laihia, Jarmo ; Bernoulli, Jenni

AIMSThe aim was to study the effect of intravesically instilled cis-urocanic acid (cis-UCA) on bladder function in an experimental rat model of acute bladder inflammation. Hyaluronic acid (HA) was used as a comparator compound.METHODSBladder irritation was induced in female rats by intravesical hydrochloric acid (HCl) infusion. Vehicle, 0.5% HA, or 2% cis-UCA solutions were infused intravesically twice a day for three consequent days. On the fourth day, urodynamical measurements were performed, the animals were sacrificed, and the bladders were removed for histopathological assessment.RESULTSHCl treatment caused significant impairment of bladder function indicated by decreased micturition intervals and voided urine volumes and induced severe voiding dysfunction observed as occurrence of overflow incontinence. These functional changes were accompanied by increased bladder weight, hemorrhage, and infiltration of inflammatory cells into the urothelium. Intravesical cis-UCA treatment recovered bladder function by significantly prolonging the micturition interval, increasing the voided volume, and reducing the occurrence of overflow incontinence. All these changes were comparable to the effects of HA.CONCLUSIONSIntravesical administration of cis-UCA was able to partially recover bladder function impaired by chemical irritation. Cis-UCA may offer a novel intravesical treatment option in some inflammatory conditions of the bladder. Neurourol. Urodynam. 35:786-791, 2016. © 2015 Wiley Periodicals, Inc.

01 Apr 2012·Journal of UrologyQ1 · MEDICINE

Antitumor Effects of cis -Urocanic Acid on Experimental Urothelial Cell Carcinoma of the Bladder

Q1 · MEDICINE

Article

Author: Jansen, Cornelius F.J. ; Pylkkänen, Liisa ; Leino, Lasse ; Oosterwijk, Egbert ; Laihia, Jarmo K. ; Hulsbergen-van de Kaa, Christina A. ; Witjes, J. Alfred ; Arentsen, Harm C.

PURPOSEWe determined the effect of protodynamic therapy against bladder cancer cells in vitro and in vivo. We investigated cis-urocanic acid in rat bladder cancer cell cultures and in an orthotopic rat urothelial carcinoma model to assess its safety and antiproliferative activity.MATERIALS AND METHODSThe rat bladder cancer cell line AY-27 was exposed to cis-urocanic acid (BioCis Pharma, Turku, Finland) at pH 6.5 or 7.4 for 2 hours. Cell viability was measured by colorimetric assay at 24 and 48 hours. For in vivo experiments AY-27 cells were instilled into the acid treated bladder of 17 rats. After 4, 7 and 10 days 14 rats were treated intravesically with cis-urocanic acid 6% (weight per volume) or vehicle. Rats were sacrificed on day 12 and the bladders were dissected. Immunohistochemical staining was done to assess apoptosis (caspase-3) and cell proliferation (Ki-67) in vivo.RESULTSCis-urocanic acid caused dose dependent, pH dependent inhibition of AY-27 cell proliferation, showing the protodynamic action at concentrations of 0.5% and 1%. At higher cis-urocanic acid doses complete cell death was observed. All tumors detected in animals treated with vehicle were muscle invasive (stage T2 or greater) but only 43% of tumors were muscle invasive in the cis-urocanic acid treated group (p=0.049). There was no difference in the percent of apoptotic or proliferating tumor cells between treatment groups. No signs of toxicity were observed.CONCLUSIONSCis-urocanic acid showed direct antiproliferative activity against rat bladder cancer cells in vitro and antitumor effects in vivo. It may have therapeutic potential as an intravesical agent for nonmuscle invasive bladder cancer.

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