Pharming's Prodarsan enters Ph I testing

Leiden, the Netherlands-based biotechnology company Pharming says 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 the agent, 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 aging-related diseases early on in their lives. There is currently no effective therapy available for the condition.

Pharming has demonstrated that Prodarsan as an oral, liquid formulation has significant effects in animal models for Cockayne Syndrome, 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 the agent 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 firm noted.

The Phase I trial 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 found that targets the pharmacological effective concentration range effectively. Following a successful completion of this trial the first studies in patients are expected to start later in 2008.