Healthcare Industry News:  dementia 

Biopharmaceuticals Neurology

 News Release - May 16, 2006

Leuprolide Acetate Stabilizes Cognitive and Functional Decline in Women With Alzheimer's Disease, Study Shows

Consistent Results Seen in 3 Endpoints

RALEIGH, N.C., May 16 (HSMN NewsFeed) -- Leuprolide acetate, when used in conjunction with standard Alzheimer's therapy, was shown to stabilize the cognitive and functional decline of women with mild-to-moderate Alzheimer's disease according to a Phase II study conducted by Voyager Pharmaceutical Corporation.

The findings are the result of a subgroup analysis of Voyager's Phase II study assessing the efficacy and safety of leuprolide acetate, when used in conjunction with acetylcholinesterase inhibitors (AChEIs), in stabilizing cognitive and global function. Participants in the 48-week double blind, placebo-controlled study were women ages 65 and older with mild-to-moderate Alzheimer's disease.

"The cognitive and functional stabilization we observed in study participants treated with the higher of the two tested doses of leuprolide acetate plus AChEIs as compared to those in the placebo group, who also received AChEIs, was encouraging in the first of our two Phase II studies," said Dr. Brian Reynolds, Director of Medical and Scientific Information at Voyager.

Voyager's Phase II study enrolled 109 women with Alzheimer's disease. Reynolds presented an analysis of data from a subset of 50 of these patients, who also received cholinesterase inhibitor therapy, at the 9th International Geneva/Springfield Symposium on Advances in Alzheimer Therapy. The symposium focused on Alzheimer's disease treatment and dementia research and was held in Geneva, Switzerland in April 2006.

Voyager will present additional Phase II trial data at the 10th International Conference on Alzheimer's Disease and Related Disorders, sponsored by the Alzheimer's Association. The company will also report on the progress of its two active Phase III trials for Alzheimer's disease. The conference will be held in Madrid, Spain, July 15 - 22, 2006.

Voyager is currently enrolling subjects for two Phase III clinical trials investigating the safety and efficacy of VP4896 in the treatment of mild-to- moderate Alzheimer's disease. Enrollment for the first trial is ahead of schedule and Voyager expects to complete enrollment of all 555 subjects before December 31, 2006.

About the Phase II Women's Study

The data presented are the results of a subgroup analysis of Voyager's 48- week double blind, placebo-controlled Phase II study. The study assessed the efficacy and safety of leuprolide acetate in stabilizing cognitive and global function in women ages 65 and older with mild-to-moderate Alzheimer's disease. The primary efficacy endpoints of the trial were scores on both the ADAS-Cog (a test of memory and cognition) and the ADCS-CGIC (a global measure of a subject's change in condition) at 48 weeks compared to baseline. There were various secondary efficacy endpoints, including scores on the ADCS-ADL (a measurement of a patient's capacity to perform activities of daily living) at 48 weeks compared to baseline. In this subgroup analysis, the mean ADAS-Cog score in the group receiving the high dose of leuprolide acetate and an AChEI declined by 0.18 points at week 48 from baseline compared to a mean decline of 3.30 points in the group receiving placebo and an AChEI. In the ADCS-CGIC analysis, 58% of the subgroup receiving the high dose of leuprolide acetate and an AChEI scored no change or better at week 48 in comparison with baseline versus 38% of the subgroup receiving placebo and an AChEI. The mean ADCS-ADL score in the subgroup receiving the high dose of leuprolide acetate and an AChEI declined 0.54 points at week 48 from baseline compared to a mean decline of 6.85 points in the subgroup receiving placebo and an AChEI.

About Voyager Pharmaceutical Corporation

Voyager Pharmaceutical Corporation is a biopharmaceutical company focused on developing drugs for diseases associated with aging and development. Voyager's scientific approach is based on the observation that many diseases of aging may be caused by changes in human reproductive hormone levels that are characteristic of the aging process. Voyager's most advanced product candidate is VP4896, a proprietary, small, biodegradable implant that is comprised of leuprolide acetate and a polymer. VP4896 decreases the amount of luteinizing hormone (LH) released by the pituitary gland which, Voyager believes, may decrease or slow the progression of Alzheimer's disease.

The active ingredient in VP4896, leuprolide acetate, has been used safely for over 20 years as a treatment for prostate cancer. Voyager's phase III trial program for VP4896 is one of only three Phase III studies that investigate the effects of new AD therapies on the rate of cognitive decline in mild to moderate Alzheimer's disease.

Voyager was founded in 2001 and is headquartered in Raleigh, N.C. For more information go to www.voyagerpharma.com.


Source: Voyager Pharmaceutical

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