Vancouver, Canada was the scene this past week of the Alzheimer’s Association International Conference 2012 (AAIC 2012). It was attended by some 4300 research scientists and neurologists from around the globe. The program included presentation of cutting edge drug trial findings, the latest refined diagnostic scans, and all research related to diagnosing and eventually halting AD.
Baxter International’s medication, IVIG/Gammagard, was one of the featured medications that had its study findings presented after its successful passage through a Phase II Clinical Trial identified as NCT # 002999988. That trial enrolled a group of volunteers numbering less than 30.
Gammagard is now about to undergo a much larger study of just over 400 enrollees who are currently being recruited at 37 study site locations in a Phase III Clinical Trial identified as NCT # 01524887. Passing a Phase III Clinical Trial is essential prior to the next step of seeking FDA approval for Gammagard.
Gammagard is a human blood product administered intravenously. Within each dose are the antibodies from the plasma of more than 1000 blood donors.
Gammagard works by applying the brakes to the deterioration process caused by the buildup of protein clumps called amyloid plaques. It also puts the brakes on the damage that is caused by inflammation. It offers hope, for the first time, of long-term stabilization of AD symptoms.
What it does not do is heal or restore any of the damage already done to the brain. Neither does it bring back the memories, cognitive abilities or the executive function of the brain that have been taken away.
Two other medications that had their study results presented were Pfizer Pharma’s Bapineuzumab, and Ely Lilly’s drug, LY2062430, otherwise known as Solanezumab.
Sadly, in an announcement on Monday July 23rd, and just days after the AAIC Conference, Pfizer disclosed that their drug, Bapineuzumab, had failed to meet all of the threshold requirements of passing its Phase III Trial.
I posted my first blog article about Alzheimer’s medications in February 2010. Listed among the promising new medications at the time were Baxter’s IVIg 10%, now being called Gammagard.
I went back through my AD Clinical Trial research notes from late 2007 into early 2008. At that time, I noted that some 90 new drugs were in the trials pipeline. Bapineuzumab was one of them. This drug, at the time, was listed as a humanized monoclonal anti AB antibody.
The washout rate of new drugs from the time of introduction to receiving FDA approval for the marketplace is brutal and a very long odds endeavor. In 2007 the odds were 1 out of every 1000 new medications making it all the way to market. The timeline from laboratory to marketplace back then ranged between 12 to 15 years. The present need, in terms of the demand for dementia and Alzheimer’s medications, is for this timeline to be compressed down to something like 3 to 5 years.
Medical researchers today now have access to some of the world’s fastest supercomputers in an effort to speed up the basic research involving an astonishing number of protein molecules, neuron cells, intracellular components and cell structures, all of which must be examined in an effort at cracking the code, the armor and the camouflage of Alzheimer’s Disease.
We cross our fingers that the effectiveness of both Gammagard and Solanezumab will survive the trials and testing ahead of them in order to reach the marketplace.
The race is on for first stopping AD altogether, then, a cure. 2020 to 2025 is the present future deadline being spoken of for such breakthroughs. That is just eight to thirteen years away. Just 4 years ago, as previously noted above, there were only 90 new medications in the clinical trial pipeline for dementia and AD.
As of July 2012, there are now 930 new drugs in that pipeline, 200 of which are in Phase III trials.
A new medication that successfully makes it to a Phase III trial has approximately a 60% chance of reaching the public marketplace.
Our sense of urgency has started to take hold.
Now hear this: “Research scientists, Keep the gas pedal floored!”
Jeff Dodson
July 27th 2012
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