Medpedia

Unfortunately it more common for new drugs to fail in Phase III trials in Alzheimer's Disease. This in spite of showing positive response in Phase II trials. Many such drugs are rushed into Phase III without doing proper dose determination, PK and ADME studiesEven the marketed drugs which are approved because of a few points reduction in MMS or ADAS scores make little difference for the patient. The reasons for high failure rate of new drugs is lack of a biomarker or objective criteria for disease assessment, biphasic response of many memory enhancing drugs, toxicity, high placebo response and lack of dose response curve. We need many more new scientific breakthroughs and leads in R&D.

Here's a good article that summarizes the financial component of the controversy:

http://bit.ly/di9mKE

"But what is troubling is how much Medivation was able to take advantage of a drug that was miles from being marketed. Dimebon, first developed decades ago as an antihistamine, had shown surprising success in a smaller trial conducted in Russia. Now, its failure is a stark reminder of the risks for Big Pharma of trying to buy its way to new drug pipelines. While Pfizer's investment is likely sunk, some Medivation executives managed to take advantage of the stock's glory days. Just two weeks ago, Medivation Chief Financial Officer Patrick Machado sold 22% of his stake for $1.1 million, outside his scheduled divestment plan."

Yoshio Miyake , Kyoto, Japan

As I have not read the detailed report from Medivation and Pfizer. I cannot give any correct views.

But I have not been expecting an effectiveness of the drug, partly because we are not able to understand how the drug acts to AD

Jennifer and Yoshio thanks for your participation and remarks. Your views once again bring us back to positive outcome in a single Phase II trial which is short term, in low number of patients, super selected and prescreened. Established firms try to confirm outcome in other Phase II trials lasting 2 years or so. Start ups, under pressure from Venture firms and investors, rush into Phase III without knowing the mode of action. I believe that the Russian trials were probably not done under GCP and may not meet regulatory standards of FDA and EMA. Even some Pfizer executives in licensing in a rushed deal might have ignored warning signs and internal audit of Russian data . Of course the founders of Medivation profited from the deal.  

I've seen a Phase 3 study recruiting for Bapineuzumab.  Read the qualifications and my father fits this.  Have any of you heard of this and are there any side effects?

As a general rule information about new drugs in development and clinical trials is held by the companies involved and released selectively. Thus it is difficult to give any assessment or clear answer. 

From my recollection ?, the drug had a problematic development. Trials were halted due to adverse events linked to the drug? Phase II trial failed in primary end point of efficacy, a subset analysis identified a subgroup of patients carrying a specific gene as responders. Phase III trials were started way back in 2007 and some problems were observed at a high dose.

Collect, read and digest all the information on the web, Scholar, PubMed and Science Direct. Contact Pfizer/Elan CNS Medical Director, FDA Med Watch, Investigator, IRB members of the hospital, your father Neurologist  and families of patients already in trial in your area. Once you have time to collect and digest all the information, you can make your own decision in the best interest of your father.

Thank you so much for your advice - I will do this.

Members,

I was asked to contribute, however, I can not, due to trial confidentiality.

Sincerely,

Gerry Lane

Julie,

I have done a multimedia interactive review of Bapineuzumab and posted it today. I would like to invite you to read it during Easter holiday and let me know if it meets your requirements and answers your question. There must be some internet chatter about the drug by caretakers or patients with so many ongoing trials. You can comment (at the end), rate and review (right hand window) as a reader or contributor.

Bapineuzumab (Pfizer, J&J, Elan) Review

http://knol.google.com/k/krishan-maggon/bapineuzumab-pfizer-j-j-elan-review/3fy5eowy8suq3/119#

If you find it useful, I will republish parts of the article in Medpedia ASAP.