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Gene Therapy for ED Appears Safe
May 20, 2008 -- Gene therapy treatment for erectile dysfunction (ED) appears safe in early tests, scientists announced today at the American Urological Association's annual meeting in Orlando, Fla.
No safety problems were seen in the 11 men with ED who got the gene therapy treatment two years ago, notes Arnold Melman, MD, professor and chairman of the urology department at New York's Albert Einstein College of Medicine.
The men got an injection of a human gene, called the Maxi-K gene, into their penis.
"The gene produces a protein that makes the Maxi-K channel. And when that channel is open, it causes the smooth muscle cells to relax," helping to facilitate erections, Melman tells WebMD. "What we're doing is correcting a problem that's induced by aging and disease."
The tests on people have been primarily focused on safety. Tests on monkeys show that the therapy does increase erectile function and other measures of sexual behavior.
Melman predicts that men with ED would get the gene therapy treatment twice a year, based on research on animals and people showing that the treatment last for about six months.
"The advantage of it is that you don't have to plan on doing anything," Melman says. "It naturalizes the event, so people can have sex without having to take a pill or inject themselves."
The gene therapy also appears to work "synergistically" with drugs such as Viagra and Cialis, "so that you can perhaps use a lower dose ... if you have these genes on board," Melman says.
Melman is a directing member of Ion Channel Innovations, the company that is developing the gene therapy treatment. He and his colleagues are also studying the Maxi-K gene therapy for the treatment of overactive bladder.
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Indication
Uroxatral® (alfuzosin HCl 10 mg extended-release tablets) is an alpha1-blocker for the treatment of the signs and symptoms of BPH.
Important Safety Information
Do not take UROXATRAL if you have liver problems or if you are taking antifungal drugs like ketoconazole or itraconazole, or HIV drugs like ritonavir.
UROXATRAL can cause a sudden drop in blood pressure, especially when starting treatment. This may lead to fainting, dizziness, and lightheadedness. Do not drive, operate machinery, or do any dangerous activity until you know how UROXATRAL will affect you. This is especially important if you already have a problem with low blood pressure or take medicines to treat high blood pressure. There may be an increased risk of low blood pressure and fainting when taking UROXATRAL in combination with blood pressure medication or nitrates, or erectile dysfunction medication.
If considering cataract surgery (clouding of the eyes), tell your eye surgeon that you are currently taking UROXATRAL or have previously been treated with an alpha-blocker.
Before taking UROXATRAL, tell your doctor if you have kidney problems.
Also, tell your doctor if you or any family member(s) have or take medications for a rare heart condition known as congenital prolongation of the QT interval.
BPH and prostate cancer can cause the same symptoms. However, UROXATRAL is not a treatment for prostate cancer.
The most common side effects with UROXATRAL are dizziness, upper respiratory tract infection, headache, and tiredness.
Please see UROXATRAL full prescribing information.
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