New hope for women with Alzheimer's disease

Jul 18 2006

Leuprolide acetate helps women with mild-to-moderate Alzheimer's disease maintain functional capabilities for a longer period of time, according to data presented Monday by Voyager Pharmaceutical Corporation.

The company shared its findings from a Phase II clinical trial in women at a symposium held during the 10th International Conference on Alzheimer's Disease and Related Disorders, presented by the Alzheimer's Association. This report expanded on the Phase II data presented in Geneva, Switzerland in April by Dr. Brian Reynolds, director of medical and scientific information for Voyager.

"Women treated with leuprolide acetate and the current standard of care, acetylcholinesterase inhibitors, better maintained their level of cognitive ability and daily activities for nearly one year," said Dr. Christopher Gregory, vice president of research at Voyager. "These findings mean that, for a sustained period of time, women treated with the drug were able to maintain their memory and their ability to do things like dress themselves."

The findings resulted from a subgroup analysis of VP-AD-103, Voyager's clinical trial testing the efficacy and safety of leuprolide acetate in women with mild-to-moderate Alzheimer's disease. The trial was a 48-week, double-blind, placebo-controlled study observing women age 65 and older.

The subgroup analysis compared two groups of women with mild-to-moderate Alzheimer's disease. The first group consisted of women treated with leuprolide acetate and acetylcholinesterase inhibitors (AChEIs). The second group consisted of women treated with placebo and AChEIs.

Women in the study were assessed on three measures: cognitive ability (measured by an assessment known as ADAS-Cog), clinical impression (a physician and caregiver assessment known as ADCS-CGIC), and ability to perform daily activities (as assessed by the caregiver on a scale known as ADCS-ADL). The treatment group performed significantly better than the placebo group on all three measures.

Nearly 90 percent of the eligible women from the Phase II trial elected to participate in an open-label extension study. Results from that study showed that women continued to benefit from treatment with leuprolide acetate for nearly one more year.

"Our trial result demonstrates that leuprolide acetate may benefit a spectrum of women with mild-to-moderate Alzheimer's disease for a sustained period of time," said Dr. Joseph DeVeaugh-Geiss, Voyager's interim chief medical officer. "These findings are encouraging as we continue to make progress with our trials in Alzheimer's disease."

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

At ICAD 2006, members of Voyager's team will also be presenting four scientific/clinical posters relating to the Phase I and II clinical trials, preclinical research linking leuprolide acetate to AD pathology and a "Hot Topics" poster that addresses data from both of Voyager's Phase II studies.

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 age 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 the 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 from baseline at week 48 compared to a mean decline of 3.30 points in the group receiving placebo and an AChEI.

In the ADCS-CGIC analysis, 58 percent 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 percent 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 from baseline at week 48 compared to a mean decline of 6.85 points in the subgroup receiving placebo and an AChEI.

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. Based on clinical evidence, Voyager believes that the reduction of LH 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 investigating the effects of this new AD therapy on the rate of cognitive decline in mild-to-moderate Alzheimer's disease.