Pharming Group N.V.
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Publicatie datum
23 apr 2008 - 11:45
Statutaire naam
Pharming Group N.V.
Titel
PHARMING STARTS CLINICAL PROGRAM IN AGEING DISEASES
Bericht
Leiden, The Netherlands, April 23, 2008. Biotech company Pharming Group NV (“Pharming”) (NYSE Euronext: PHARM) announced today that its wholly owned subsidiary DNage has started a Phase I clinical study to evaluate the pharmacokinetics and tolerability of Prodarsan® in humans.
Premature ageing, the primary target of Prodarsan®, is a group of rare genetic diseases which manifests itself in several forms that are genetically and clinically similar although not identical. Dependent on the specific form of the disease, patients have a strongly reduced life expectancy and exhibit many ageing-related diseases early on in their lives. There is currently no effective therapy available for these patients.
Pharming has demonstrated that Prodarsan® as an oral, liquid formulation has significant effects in animal models for Cockayne Syndrome (“CS”). CS is one of the more common forms of premature ageing and is characterized, amongst others, by growth failure, mental retardation, eye abnormalities and a reduced life expectancy. The positive effects of Prodarsan® in preclinical testing on life expectancy in general and more specifically on the eye abnormalities are promising for further development of the product and its testing in humans.
The Phase I trial that is now being conducted consists of a combined single and multiple dose escalating clinical study in healthy volunteers. By studying the pharmacokinetics and tolerability of Prodarsan® and the effects of food intake on the absorption and elimination of the product, an oral dosing scheme will be determined that targets the pharmacological effective concentration range effectively. It is expected that following a successful completion of this trial the first clinical studies in patients will start later in 2008.
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