Gene transfer for the therapy of erectile dysfunction: progress in the 21st century

Gene transfer represents the next potential era of advancement in medicine for the prevention of the effects of aging or for treatment of genetic or acquired disease. For gene transfer to be a practical successor to today's oral and minimally invasive therapies, the product must have a high safety profile and a long duration of effectiveness to correct the need for on-demand administration. Several types of vectors have been used in preclinicals studies, but because of widely publicized adverse events, progress using viral vectors in humans has been limited. There is a current phase I human trial using naked DNA as the vector with the maxi-K gene to modify cellular contractility. Preliminary results in the safety trial thus far have shown no treatment-related adverse events, no transfer to the semen, and the possibility of efficacy in one participant.