In this Phase I study, single and multiple escalating doses were administered to healthy volunteers. The data obtained show that Prodarsan is safe and well tolerated when used in dosages that have earlier shown to yield positive effects in preclinical studies. Since Prodarsan will be used as an oral, liquid formulation the effects of food intake on absorption and elimination of the product were also investigated.
Based on these data, combined with data generated in the preclinical program, an oral dosing scheme has been established that will be used in clinical studies with patients suffering from Cockayne syndrome.
Prodarsan is a defined combination of small molecules which is being developed to delay the progression of age-related diseases.
Rein Strijker, general manager of DNage and member of the board of management of Pharming, said: The data announced today, combined with the positive effects of Prodarsan in preclinical testing, are promising for further development of this program.
In consultation with the regulatory authorities, we are determining the next steps to be taken for clinical development program for Prodarsan. We look forward to begin testing the product in patients suffering from premature ageing in the near future.