Gene therapy for male erectile dysfunction.

The potential clinical advantages of a gene transfer therapy-based approach to treatment of genitourinary smooth muscle-based disorders are several: potential single therapy for restoration of normal bladder or erectile function; eliminating the need for daily medication; use in combination with other therapies to reduce dose requirements and side effects; and development of mechanism-based, patient-specific treatment approaches. With the safe administration of hMax-K to men with erectile dysfunction in the first human phase 1 trial and the initiation of the phase 1 trial of hMaxi-K for patients who have detrusor overactivity, we have entered an exciting new era in the development of safe enduring therapies for genitourinary disorders.