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