May 12, 2010

Medivation (Dimebon) Gives Dotty the Axe

Medivation pulls the plug on moderate to late stage Alzheimer's patients.....
By Bob DeMarco
Alzheimer's Reading Room

As many of you know, on January 6, 2010, Dotty was enrolled in one of the two Dimebon clinical trials for patients in the moderate to severe stage of Alzheimer's disease.

On Monday, May 10, Pfizer (PFE) and Medivation (MDVN) announced that they were canceling both later stage trials for Dimebon.

Dotty got the Axe.

I'll start by saying we are not angry, or mad, at Pfizer or Medivation. Yes, we are disappointed and with good reason.

While it is impossible to know for certain, it seemed likely to me that Dotty was receiving the drug, Dimebon, and not the placebo. Let me put it this way. If Dotty was not receiving the drug then I can only conclude that I am one of the worlds greatest caregivers.

Dotty was evidencing new, and frankly, wonderful behaviors. It was like Dotty was put in the Way-Bac machine.

I wrote on January 6 that I would not comment on the Dimebon clinical trial until the end of the 26 week trial period (late July). I made that decision for all the obvious reasons.

Now it seems I am good to go since Dotty is no longer enrolled and the trial has been canceled.

I can say I am really disappointed because based on what I saw with my own eyes, and our experience, Dimebon could very possibly have great merit for Alzheimer's patients.

I understand that Dotty is a sample of one, however, my conclusions about Dimebon are based not only on my experience in the front row, but also on conversations with several neurologist and more than a handful of patients that were enrolled in a Dimbeon clinical trial.

Every neurologist told me that they were receiving the same feedback from Alzheimer's caregivers -- many of the patients in the various Dimebon studies were described as "more engaged". The patients were evidencing greater awareness, were more conversant, and seemed to have an improved attitude.

In my opinion, there is a very thin line between behavior and memory when it comes to Alzheimer's. Right now, Medivation is trying to prove that Dimebon either slows decline or improves memory in persons suffering from Alzheimer's disease. This is the primary outcome they are searching for right now. Is this a mistake?

In the Dimebon Connection Study, the drug failed miserably on its primary outcome -- memory. However, it did show significant results on a secondary outcome -- behavior.

I want everyone to keep something in mind as they read this -- I am not a doctor, I am not a scientist. I am an Alzheimer's caregiver.

I intend to write a series of articles about the wonderful changes I saw in Dotty, how participation in this clinical trial changed some of my views about caregiving, why I think the drug companies might not be understanding Alzheimer's caregiving in a way they should, and what I think and believe about the future of Dimebon.

In the meantime know this. From week 6 to 18 in the clinical trial life with Dotty was very different. She started talking to me about world events and the newspaper. She smiled her cute little smile everyday and many times. She sang more. Even her new revelation each day that the Oleanders are in full bloom was noted with greater emotion and passion and wonder.

Stay tuned, I am about to let it all hang out.

From the Medivation press release:

"After thorough review of all available dimebon data, including the disappointing CONNECTION results, Medivation remains committed to determining whether dimebon may offer clinical benefit to Alzheimer's and Huntington disease patients," said David Hung, MD, president and chief executive officer of Medivation.

"We will continue to enroll patients in the 12-month Phase 3 CONCERT trial in mild-to-moderate Alzheimer's patients and the six-month Phase 3 HORIZON study in Huntington disease, and will stop our two ongoing Phase 3 trials in moderate-to-severe Alzheimer's disease. In reaching this conclusion, we considered all dimebon data generated thus far, including the negative CONNECTION data, the clinical benefit seen in two prior dimebon trials in mild-to-moderate Alzheimer's disease and Huntington disease, the excellent safety and tolerability profile in all dimebon trials to date covering more than 2,000 patients, the preclinical data consistently showing that dimebon is pharmacologically active, and the potential risks and returns of continuing development for Alzheimer's and Huntington diseases.

We believe both the CONCERT and HORIZON studies offer independent pathways to registration, and we will be meeting with the Food and Drug Administration this quarter to discuss the CONNECTION data and obtain guidance on our proposed regulatory path forward."

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Original content Bob DeMarco, the Alzheimer's Reading Room