FDA Approves Dnage’s Prodarsan

FDA has approved DNage’s Investigational New Drug application for Prodarsan, allowing the company to initiate a clinical trial in children suffering from Cockayne Syndrome (CS). DNage is a wholly-owned subsidiary of Pharming Group.

In this clinical study, which is expected to be conducted in the fourth quarter of 2009, the pharmacokinetics (PK) of single and multiple escalating doses of Prodarsan will be evaluated in a small number of paediatric patients with CS.

The company said that the safety and tolerability of the product will also be investigated in the study.

In late 2008, a phase I study on Prodarsan appeared to be safe and well tolerated in dosages that had earlier shown to yield significant beneficial effects in animal models of CS.

Reportedly, after the completion of the planned clinical study and the ongoing toxicology testing, DNage expects to perform another clinical trial to evaluate the efficacy of Prodarsan in alleviating symptoms of CS.

Rein Strijker, general manager of DNage and chief commercial officer at Pharming, said: Prodarsan, as the first product being developed with DNage technology, is testimony to the great potential of this approach in treating diseases related to ageing in humans. The positive data with Prodarsan in preclinical and the earlier completed Phase I studies are encouraging for its further development.

We look forward to initiating studies in CS patients and will also continue to develop a number of other product candidates for the treatment of other premature ageing diseases as well as ageing diseases in the elderly population. With the continued increase in average life-expectancy of humans in many parts of the world, there is a great medical need for new products in the field of diseases associated with old age. We believe that our innovative DNage technology can contribute to develop new approaches in this area, he added.