First patients enrolled in the phase 2 a, proof of concept study in plaque psoriasis, investigating the efficacy of valrubicin in a new reformulated cream.
On 2 March 2010 the first patients were enrolled in the proof of concept study in psoriasis patients.
Valrubicin in a new reformulated cream with improved skin penetration, will be applied under occlusion once daily in a standard Plague Psoriasis Test (PTT). In addition patients will have valrubicin cream and placebo (vehicle without active ingredient) applied to a larger plaque once daily without occlusion for 3 weeks. Biomarkers and histology will be assessed in a subset of patients. Valrubicin cream in two strengths will be compared to commercial reference standard topical treatments (Calcipotriol and Betamethasone valerate) With the new valrubicin cream formulationValderm expects to confirm the promising results obtained in the pre-clinical study completed in July 2009. Valrubicin cream is a first in class novel treatment for psoriasis and hyperproliferative skin disorders.
Publication efficacy/ mode of action valrubicin
In the September 2009 issue of Journal of Investigative Dermatology (JID 10 Sept. 2009, 130, p455-463), the results of the pre-clinical study investigating the efficacy of valrubicin cream in a pre-formulation in human psoriatic skin engrafted onto HuSCID mice are presented. The validated model has a high predictive value for the efficacy in future clinical studies and in real use. The study concludes that valrubicin in the topical pre-formulation successfully treats psoriasis in a xenograft transplantation model, suggesting that topical valrubicin may be an upcoming treatment for psoriasis.
The efficacy of valrubicin in the cream pre-formulation in the transplantation model confirms the findings previously obtained from in- vitro/ in-vivo studies regarding the mode of action of valrubicin. It has been demonstrated that valrubicin has anti-proliferative, apoptosis inducing and anti-inflammatory effects.
The pre-formulation used in the study reported in JID, has recently been replaced by a new re-formulated valrubicin cream having an improved efficacy due to enhanced skin penetration, still maintaining the safety.
The improved efficacy of the new reformulated valrubicin cream has been demonstrated in July 2009 using the identical pre-clinical model as presented in the publication thus confirming the enhanced skin penetration.
Patent application filed, new formulations and new indications
Based on new promising results of the efficacy of valrubicin in the new formulations developed recently, Valderm has filed a patent application to secure rights to new indications and new formulations.
Valderm has formerly obtained patent rights for usage of valrubicin in psoriasis in USA, EU, Japan, Australia and New Zealand.
Promising results obtained in a pre-clinical study with the new valrubicin cream formulation
The efficacy of valrubicin in a newly developed cream replacing the pre-formulation formerly used, has been investigated in a validated xenograft transplantation model. The identical model was previously used to investigate the efficacy of the pre-formulation.
The study duration of the present study was 3 weeks with once daily application of all products tested. The commercial standard topical treatments (Calcipotriol and Betamethasone valerate) were included as reference treatments. A clinical proof of concept study in psoriasis patients has been scheduled for Q1-2010 to confirm the results of the pre-clinical study.