Memory Pharmaceuticals : Phase 1 Multiple Ascending Dose Study of R4996/MEM 63908

Sept. 26, 2008 - Memory Pharmaceuticals Corp. (Nasdaq: MEMY) announced that it has completed its Phase 1 multiple ascending dose study of R4996/MEM 63908 in healthy volunteers. The multiple ascending dose study is the fourth and final study in the Company's Phase 1 program for R4996/MEM 63908, a partial agonist of the nicotinic alpha-7 receptor being developed in collaboration with Roche. Memory Pharmaceuticals expects to report top-line results from the entire Phase 1 program in the fourth quarter of 2008.


"We conducted a robust and comprehensive Phase 1 program for R4996/MEM 63908 during which over 100 volunteers took R4996/MEM 63908. The data from these studies will provide us and our partner Roche with important insights into the safety, dosing and appropriate development path for the compound," stated Stephen Murray, M.D., Ph.D., Chief Medical Officer of Memory Pharmaceuticals. "R4996/MEM 63908, the second compound in our nicotinic alpha-7 receptor program, has the potential to address serious cognitive disorders such as Alzheimer's disease, and we look forward to analyzing the data from these studies."... Memory Pharmaceuticals' Press Release -

Baxter : Phase III Trial for the Treatment of Alzheimer's Disease

September 22, 2008 — Baxter Healthcare Corporation announced initiation of a Phase III clinical trial following U.S. Food and Drug Administration (FDA) review of its investigational new drug application to evaluate GAMMAGARD LIQUID [Immune Globulin Intravenous (IGIV)], marketed as KIOVIG in European Union, for the treatment of mild-to-moderate Alzheimer’s disease. This trial is expected to be the first of two pivotal Phase III trials required to support filing for regulatory approval for GAMMAGARD LIQUID as a potential treatment for the disease.

The Phase III trial is a prospective, 18-month, randomized, double-blind, placebo-controlled, two dose-arm, parallel study in 360 subjects of both genders, ages 50 to 89 years old, with dementia of mild-to-moderate severity. The study will determine whether GAMMAGARD LIQUID treatment results in a significantly slower rate of decline of cognitive and other functions compared to placebo. Approximately 40 U.S. leading academic centers have been identified and will begin clinical trial enrollment within the next several weeks... Baxter Healthcare's Press Release -

Xel Pharmaceuticals : Successful Completion of Prototype Once-A-Week Huperzine A Transdermal Patch for Alzheimer's Disease

September 10, 2008 — Xel Pharmaceuticals, Inc. announced the completion of the development of its once-a-week Huperzine A transdermal patch for the treatment of Alzheimer's Disease (AD). The prototype transdermal patch can deliver 400–800 mcg of Huperzine A per day for up to seven days. Huperzine A is a naturally occurring alkaloid found from the club moss Huperzia serrata that has been used for decades in China as a prescription medication for the treatment of dementia. Huperzine A is a potent, highly selective and reversible inhibitor of acetyl cholinesterase. Additionally, Huperzine A has anti-oxidative properties and possesses neuro-protective properties against glutamate that induce neuronal toxicity at the N-methyl-D-aspartate (NMDA) receptor... Xel Pharmaceuticals' Press Release -

Memory Pharmaceuticals and Roche : R3487/MEM 3454 Development Program

Sept. 17 , 2008 - Memory Pharmaceuticals Corp. (Nasdaq: MEMY) announced that it has amended its nicotinic alpha-7 receptor agonist agreement with Roche to expand the Phase 2 development program for R3487/MEM 3454 in cognitive impairment associated with schizophrenia (CIAS).

Memory Pharmaceuticals is currently conducting a Phase 2 trial of R3487/MEM 3454 in CIAS, and the companies have agreed to expand the study to allow for an increase in the target number of patients enrolled in the trial to up to approximately 212 patients, which will provide for a more robust data set and increase the potential for the study to facilitate advancing the compound into a pivotal trial. In addition, Roche has notified Memory Pharmaceuticals that it intends to initiate a Phase 2 trial of R3487/MEM 3454 in Alzheimer's disease starting either at the end of this year or at the beginning of 2009... Memory Pharmaceuticals' Press Release -

AstraZeneca and Targacept : top-line results from Phase IIb study of AZD3480 in Alzheimer’s disease

September 15, 2008 – AstraZeneca (NYSE:AZN) and Targacept, Inc. announced that results from the Phase IIb clinical trial of AZD3480 (TC-1734) conducted by AstraZeneca in mild to moderate Alzheimer’s disease were inconclusive.

In the 12-week placebo-controlled study, known as the Sirocco trial, neither the active comparator donepezil nor AZD3480 met the trial’s criteria for statistical significance on the primary outcome measure, ADAS-Cog (Alzheimer’s Disease Assessment Scale – Cognition Subscale.) Both results were impacted by an improvement in the placebo group.

At two of the three doses tested, AZD3480 showed an improvement on the secondary outcome measures ADCS-CGIC (Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change, a 7-point scale), a widely accepted measure of clinician assessment of change in patients’ behavior and ability to function, and MMSE (Mini Mental State Examination, a 30-point scale), a quantitative cognition scale commonly used by neurologists in a clinical setting. Of the three AZD3480 doses, the middle dose performed best on both measures (0.5 point improvement, ADCS-CGIC and 0.9 point improvement, MMSE). Donepezil also showed an improvement on ADCS-CGIC (0.2 point improvement) and the MMSE (1.0 point improvement). Neither donepezil nor AZD3480 showed improvement in any domain of the Cognitive Drug Research computerized test battery in the pooled dataset of all subjects... AstraZeneca's Press Release - Targacept's Press Release -

Pfizer and Medivation : Global Agreement to Co-Develop and Market Dimebon for the Treatment of Alzheimer's and Huntington's Diseases

Sep 03, 2008 - Pfizer Inc (NYSE: PFE) and Medivation, Inc.(NASDAQ: MDVN) announced that they have entered into an agreement to develop and commercialize Dimebon, Medivation's investigational drug for treatment of Alzheimer's disease and Huntington's disease. Dimebon currently is being evaluated in an international, confirmatory Phase III trial in patients with mild-to-moderate Alzheimer's disease.
Under the terms of the agreement, Medivation will receive an up-front cash payment of $225 million. Medivation also is eligible to receive payments of up to $500 million upon the attainment of development and regulatory milestones plus additional undisclosed commercial milestone payments. Medivation and Pfizer will collaborate on the Phase III program in Alzheimer's disease, Huntington's disease development and regulatory filings in the United States. The companies will share all U.S. development and commercialization expenses along with U.S. profits/losses on a 60 percent/40 percent basis, with Pfizer assuming the larger share of both expenses and profit/losses. In addition, Medivation will co-promote Dimebon to specialty physicians in the U.S...


... Alzheimer's disease leads to the death of brain cells and the loss of nerve connections in areas of the brain that govern memory, thinking and behavior. Alzheimer's disease gradually destroys a person's memory and ability to learn, reason, make judgments, communicate and carry-out daily activities. No currently marketed Alzheimer's disease drug appears to stop brain cell death and prevent or restore lost nerve connections.
Dimebon is an orally-available, small molecule that has been shown to inhibit brain cell death in preclinical models relevant to Alzheimer's disease and Huntington's disease, making it a potential treatment for these and other neurodegenerative conditions. Based on preclinical data generated to date, Dimebon appears to improve the function of mitochondria, the energy generators in cells that play a vital role in governing brain cell health, growth and overall function. Dimebon also has been shown to stimulate the outgrowth of nerves from brain cells, or neurites, a process that is believed to play an important role in restoring or generating new brain cell connections... Medivation's Press Release - Pfizer's Press Release -