ASCEND Therapeutics Launches Andrin Trial in Australia
Study Tests Efficacy and Safety of Dihydrotestosterone Gel For Prevention of Prostate Growth
July 16, 2004 - Herndon, VA
- ASCEND Therapeutics, a leading researcher and developer of pharmaceutical transdermal therapies, today announced the launch of a new study to evaluate the efficacy and safety of Andrin, (transdermal dihydrotestosterone gel) to prevent prostate growth in middle-aged men.
Prostate growth, or benign prostate hyperplasia (BPH), is a common condition in older men. The disease, which affects an estimated 14 million men in the U.S. alone, causes the prostate gland to slowly grow bigger. This growth creates pressure on the urethra, which in turn causes the flow of urine to be slower and less forceful. Men with BPH often need to get up repeatedly at night to urinate and may need to urinate more frequently during the day. Other symptoms include difficulty in starting the urine flow and dribbling after urination ends. Little is known about the causes of BPH, and no medication for prevention currently exists.
Older men undergoing testosterone therapy for the treatment of androgen deficiency are at increased risk of accelerating prostate disease. Although BPH and prostate cancer share common risk factors and often coexist, they are distinctly different prostate diseases.
"Benign prostate hyperplasia is incredibly common. Nearly every man who lives out his full life expectancy can expect to be affected by this disorder," said Jay Bua, president and CEO of ASCEND Therapeutics. "At the same time, as the baby boomer population ages, a greater number of men are suffering from late onset hypogonadism, or symptoms associated with androgen deficiency. We're developing a transdermal therapy for late onset hypogonadism that we hope will prevent the discomfort and anxiety of BPH and other chronic prostate conditions."
In previous clinical trials with Andrin, the volume of prostate growth has been shown to be reduced. This new study is the most comprehensive to date and is expected to corroborate earlier findings. If previous results are confirmed, this study would provide additional support for the rationale that Andrin can prevent prostate growth in middle-aged men. Preliminary study results are expected in mid-2006.
The double-blind, placebo-controlled, randomized Phase 2 trial will be conducted in conjunction with the University of Sydney in Australia and will involve 100 healthy men over the age of 50. Participants will apply either DHT or a placebo gel to their shoulders, upper arms and thighs every day for 24 months.
About ASCEND Therapeutics
ASCEND Therapeutics is a biopharmaceutical company focused on the use of transdermal drug delivery technology to overcome therapeutic barriers and raise the standard of care for certain chronic conditions. For more information about ASCEND, you may visit the company's Web site at www.ascendtherapeutics.com