The primary goal of the study was to determine the safety and tolerability of the new therapy. However, the results also showed that at the highest doses, men reported highly significant improvements in erectile function.
The DNA segments ?mixed into plasma ?were injected into the corpus cavernosum, expandable tissue along the length of the penis that fills with blood during erection. A variety of clinical and laboratory tests were used to assess safety. In addition, effectiveness was measured using the International Index of Erectile Function scale, a questionnaire that is commonly used to measure ED. Patient responses were validated by their partners.
Researchers identified no safety issues with the treatment. Participants who received the highest two doses had apparent sustained improvements in ED as measured by the questionnaire. The researchers said that a larger study that includes a "control" group treated with a placebo is needed to confirm the safety and effectiveness of the treatment.
Other researchers on the project were Melman, Natan Bar-Chama, M.D., with Mount Sinai School of Medicine, Andrew McCullough, M.D., with New York University School of Medicine, and Kelvin Davies, Ph.D., with Albert Einstein College of Medicine.
The technology is being developed by Ion Channel Innovations (ICI), a development stage biotechnology company, in which Christ and Melman are co-founders and directing members. The therapy is known as ion channel therapy because the proteins it targets are potassium channels, "gates" within cells critical for contraction and relaxation of smooth muscle.
At the Wake Forest Institute for Regenerative Medicine, Christ is con
Source:Wake Forest University Baptist Medical Center