A few weeks ago, I came across an article written by John Carroll at the online website FierceBiotech (www.fiercebiotech.com). The article was entitled, Alzheimer’s R & D suffers as trial failure rate hits an astounding 99.6%.
My immediate reaction was, this cannot be true. Turns out, sadly, that it is true.
Jeffrey Cummings, director of the Cleveland Clinic Lou Ruvo Center for Brain Health has been researching the medication studies and clinical trial data available at www.clinicaltrials.gov for the time period between 2002 to 2012. He reported his findings to FierceBiotech that determined that the clinical trial failure rate for a new Alzheimer’s drug was indeed 99.6%.
Three most recent Phase III clinical trials that ended in failure with their respective new drugs were Ely Lily and their Solanezumab, J & J’s Bapineuzumab, and, Pfizer Pharmaceuticals version of Bapineuzumab. A successful Phase III clinical trial is the last step in the process for a pharmaceutical company to obtaining FDA approval of the new drug and delivering it to the consumer marketplace. It is worth noting that the time a new drug takes to reach the market place from its original inception in a laboratory is between 12 to 15 years. The total financial expenditure for all this according to industry claims comes to approximately 1 billion dollars. That’s for just bringing one drug successfully to consumers.
The bigger pharmaceutical firms are starting to move away from investing their money in any medication that deals with late stage Alzheimer’s. The thinking within the industry is that it is too late to do anything measurably corrective for anyone with late stage AD.
The National Institute of Health (NIH) devotes $600 million a year just for Alzheimer’s research. Though this is a substantial sum, it represents approximately one tenth of the money that is directed towards cancer drug research. The large pharmaceutical firms contend that if the NIH would pump a greater amount of funding into AD and neurological research they would up the investment risk ante as well.
So where do we go from here? Is there anything offering hope out there for AD?
Promising new work is being done with delivering small amounts of medications across the so called blood-brain barrier. Nature provided us with this barrier as a means of preventing harmful and infectious organisms from entering the brain. It has taken scientists the better part of the past century to learn how to introduce what are known as small-molecules across this barrier and into the brain. To make a difference in treating a disease such as Alzheimer’s, Huntington’s disease, or a brain cancer, a step up to large-molecule medications is required.
The transferrin receptor pathway is a natural protein transport mechanism that is one of the hot research areas to use to transport large-molecule drugs into the brain.
On January 13th 2014, www.fiercedrugdelivery.com reported that Roche laboratories had developed a transferrin receptor pathway delivery method for getting their experimental drug, gantenerumab into the brain to reduce amyloid plaque.
On March 19th 2014, www.fiercedrugdelivery.com reported that AstraZeneca’s MedImmune had worked out a deal with Canada’s Bioasis Technologies to utilize their version of a blood-brain barrier breaching technique called the Transcend platform. The Transcend platform acts a shuttle to piggy-back medications across the blood-brain barrier directly into the brain.
Another area of early detection research has been underway in Australia. An early diagnosis trial in Perth involves an eye test to identify who will develop AD up to 20 years before the first disease symptoms begin to appear has shown promise. Natasha Harradine of ABC (Australian Broadcasting Corporation) News reported about this study on Sunday July 13th 2014. The trial participants consumed curcumin, a yellow compound found in the spice turmeric. The curcumin makes any beta-amyloids glow in an eye scan. This particular trial is a joint project between the CSIRO, Edith Cowan University and the McCusker Foundation.
While these are promising new technologies for catching AD very early in it’s development, I don’t believe that researchers should completely give up on our loved ones who have already descended into late stage AD. NIH and Big Pharma, please take note and up the anty with more funding….just like what’s been done with cancer and HIV research. Breakthrough medications and treatments for both of these diseases did not come through cheaply.
Jeff Dodson
July 21st 2014
My immediate reaction was, this cannot be true. Turns out, sadly, that it is true.
Jeffrey Cummings, director of the Cleveland Clinic Lou Ruvo Center for Brain Health has been researching the medication studies and clinical trial data available at www.clinicaltrials.gov for the time period between 2002 to 2012. He reported his findings to FierceBiotech that determined that the clinical trial failure rate for a new Alzheimer’s drug was indeed 99.6%.
Three most recent Phase III clinical trials that ended in failure with their respective new drugs were Ely Lily and their Solanezumab, J & J’s Bapineuzumab, and, Pfizer Pharmaceuticals version of Bapineuzumab. A successful Phase III clinical trial is the last step in the process for a pharmaceutical company to obtaining FDA approval of the new drug and delivering it to the consumer marketplace. It is worth noting that the time a new drug takes to reach the market place from its original inception in a laboratory is between 12 to 15 years. The total financial expenditure for all this according to industry claims comes to approximately 1 billion dollars. That’s for just bringing one drug successfully to consumers.
The bigger pharmaceutical firms are starting to move away from investing their money in any medication that deals with late stage Alzheimer’s. The thinking within the industry is that it is too late to do anything measurably corrective for anyone with late stage AD.
The National Institute of Health (NIH) devotes $600 million a year just for Alzheimer’s research. Though this is a substantial sum, it represents approximately one tenth of the money that is directed towards cancer drug research. The large pharmaceutical firms contend that if the NIH would pump a greater amount of funding into AD and neurological research they would up the investment risk ante as well.
So where do we go from here? Is there anything offering hope out there for AD?
Promising new work is being done with delivering small amounts of medications across the so called blood-brain barrier. Nature provided us with this barrier as a means of preventing harmful and infectious organisms from entering the brain. It has taken scientists the better part of the past century to learn how to introduce what are known as small-molecules across this barrier and into the brain. To make a difference in treating a disease such as Alzheimer’s, Huntington’s disease, or a brain cancer, a step up to large-molecule medications is required.
The transferrin receptor pathway is a natural protein transport mechanism that is one of the hot research areas to use to transport large-molecule drugs into the brain.
On January 13th 2014, www.fiercedrugdelivery.com reported that Roche laboratories had developed a transferrin receptor pathway delivery method for getting their experimental drug, gantenerumab into the brain to reduce amyloid plaque.
On March 19th 2014, www.fiercedrugdelivery.com reported that AstraZeneca’s MedImmune had worked out a deal with Canada’s Bioasis Technologies to utilize their version of a blood-brain barrier breaching technique called the Transcend platform. The Transcend platform acts a shuttle to piggy-back medications across the blood-brain barrier directly into the brain.
Another area of early detection research has been underway in Australia. An early diagnosis trial in Perth involves an eye test to identify who will develop AD up to 20 years before the first disease symptoms begin to appear has shown promise. Natasha Harradine of ABC (Australian Broadcasting Corporation) News reported about this study on Sunday July 13th 2014. The trial participants consumed curcumin, a yellow compound found in the spice turmeric. The curcumin makes any beta-amyloids glow in an eye scan. This particular trial is a joint project between the CSIRO, Edith Cowan University and the McCusker Foundation.
While these are promising new technologies for catching AD very early in it’s development, I don’t believe that researchers should completely give up on our loved ones who have already descended into late stage AD. NIH and Big Pharma, please take note and up the anty with more funding….just like what’s been done with cancer and HIV research. Breakthrough medications and treatments for both of these diseases did not come through cheaply.
Jeff Dodson
July 21st 2014
