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Senior Citizens & Sex

Erectile Dysfunction, Overactive Bladder and More May be Treated by Simple Gene Transfer

Potential alternative to oral drugs, like Viagra, which are not effective for up to 40%

November 30, 2006 – Okay, senior men, how about this – a simple gene transfer that will treat erectile dysfunction and, at the same time, treat overactive bladder, irritable bowel syndrome and asthma. Researchers at Wake Forest University School of Medicine say their test is showing promise. This is encouraging news for senior citizens, who will likely suffer from most of these ailments, if they live long enough.

 

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Read the latest news on Senior Citizens & Sex

 

"In the small pilot study, this new therapy was well tolerated and safe," said George Christ, Ph.D., senior researcher and a professor at the Institute for Regenerative Medicine at Wake Forest University School of Medicine. "It provides evidence that gene transfer is a viable approach to treating ED and other diseases involving smooth muscle cells."

The results of the study, which included 11 men with ED, are reported online today in Human Gene Therapy. The technology was developed by Christ and Arnold Melman, M.D., when they worked together at Albert Einstein College of Medicine in the Bronx, New York.

Unlike traditional gene therapy, the gene transfer approach being pioneered by Christ and Melman does not change the DNA or genetic code of cells. Instead, small pieces of DNA reach the nuclei of cells and this causes them to increase production of particular proteins. These proteins help relax smooth muscle cells, the type of muscle found in the penis as well as in hollow organs such as the bladder. Relaxing the tissue allows the penis to fill with blood and become erect.

Previous research has shown that more than 50 percent of men between 40 and 70 years old and 70 percent over age 70 may have ED. The new therapy is a potential alternative to oral medications, such as Viagra, which are not effective for an estimated 30 to 40 percent of men with ED.

A possible advantage of gene transfer is that a single treatment could last for months. In the current study, improvements were maintained through the 24 weeks of study.

The study was conducted from May 2004 to May 2006 at Mount Sinai School of Medicine and New York University School of Medicine. Men ranged from 42 to 80 years old with a mean age of 59. Six subjects were white, four were black and one was Hispanic. In half of the subjects, the cause of ED was diabetes or cardiovascular disease – both of which can interfere with the ability of smooth muscle cells to relax.

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.

  Erectile dysfunction might play role in heart disease  
 

Nov. 30, 2006 - Men suffering from erectile dysfunction (ED) may need to worry more about their hearts than their diminished sexual function.

Dr. Stephen Lapin, urologist with The Methodist Hospital in Houston, says an early warning sign of heart disease is when atherosclerotic plaque begins to form in the blood vessels, restricting blood flow. This plaque is more damaging to penile circulation than in other vessels due to their small size.

Erectile dysfunction affects more than 300 million men worldwide between the ages of 40 and 70. Lapin believes if urologists are aware of this connection that they can alert their patients who can then make changes in diet and exercise.

 

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 continuing to pursue the therapy in collaboration with ICI, and is also exploring the potential of combining gene transfer with traditional oral medications to further increase the clinical utility of the technology. The Albert Einstein College of Medicine at Yeshiva University owns the ICT patents and has granted the company exclusive, worldwide rights.

Editor's Notes:

Wake Forest University Baptist Medical Center is an academic health system comprised of North Carolina Baptist Hospital and Wake Forest University Health Sciences, which operates the university’s School of Medicine. U.S. News & World Report ranks Wake Forest University School of Medicine 18th in family medicine, 20th in geriatrics, 25th in primary care and 41st in research among the nation's medical schools. It ranks 32nd in research funding by the National Institutes of Health. Almost 150 members of the medical school faculty are listed in Best Doctors in America.

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