BioCis Pharma Reports Positive Phase IIa Clinical Results in Atopic Dermatitis

July 3, 2009

TURKU, Finland, July 3 /PRNewswire/ — BioCis Pharma Ltd., a privately
held drug development company with its headquarters in Turku, Finland,
announced positive results from its Phase IIa clinical trial of ProtoCure(TM)
emulsion cream, the company’s novel topical drug for dermatology. This
double-blind, placebo-controlled study, conducted in Finland, included 13
patients with mild to moderate atopic dermatitis who applied the ProtoCure
emulsion cream to the affected skin areas twice daily for up to four weeks.
The objectives were to evaluate the tolerability, pharmacokinetics, and
efficacy of the topical treatment.

Study results showed excellent safety profile, and no serious adverse
events were reported during the study. No patient dropped out due to adverse
side effects of the treatment. Pharmacokinetic analyses showed no systemic
exposure to the active ingredient of the product. Efficacy was assessed by
performing instrumental measurements of skin lesion redness (erythema) and
skin barrier function by trans-epidermal water loss (TEWL) during the 28-day
period. Physician assessments, such as Eczema Area and Severity Index (EASI)
were also evaluated. ProtoCure emulsion cream was superior to placebo in
decreasing skin redness and improving skin barrier function. Statistically
significant improvement was observed as early as day 10 after begining
treatment. There was also a significant improvement in EASI score over the
whole treatment period for ProtoCure emulsion cream as a sign of positive
treatment effect. The EASI score difference did not reach statistical
significance when compared to placebo, mainly due to the small number of
patients studied.

“We are very pleased with the promising results of this study,” says

Lasse Leino, CEO of BioCis Pharma. “Skin barrier dysfunction is now
recognized as a hallmark feature of atopic dermatitis. Any drug showing
capacity for restoring this disturbance has significant potential in atopic
dermatitis therapy. Based on our results, ProtoCure(TM) emulsion cream holds
great promises in the treatment of inflammatory skin disorders.”

Atopic dermatitis is a chronic inflammatory disease of the skin with an
onset typically already in infancy. It affects up to 20 per cent of the
general population in the Western countries, and the prevalence rate is
rising. Atopic dermatitis may significantly impair the quality of life of
those affected. Existing treatments often have undesirable side effects and
do not always meet the needs of patients.

BioCis Pharma Ltd. is a Karolinska Development portfolio company.

BioCis Pharma Ltd is an innovative drug development company developing
drug therapies based on a novel, patented therapeutic principles that target
unmet medical needs in substantial therapeutic markets including
inflammation, allergy, and cancer. The company’s main investors are
Karolinska Development AB (publ.), Finnish Industry Investment Ltd., and Etra
Invest Ltd.


Contacts: Dr. Lasse Leino, CEO, BioCis Pharma Ltd., mobile phone
+358-40-849-4694, lasse.leino@biocis.com

SOURCE BioCis Pharma Ltd

Source: newswire

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