Sunday, August 28, 2011

Alzheimers Drug Treatment Progress



Baxter’s New Treatment for Alzheimer’s Delays, Partly Reverses Disease!

by Aaron Saenz April 15th, 2010 | Comments (2)
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Baxter announced that immunotherapy product Gammagard is effective in treating Alzheimer's.
There are few diseases that are as terrifying as Alzheimer’s. Losing your memory, your comprehension, and knowing all the while that your life is slowly fading from your mind. It’s a very scary reality for the 30 million people on the planet who have it. To date there are no real ways to cure the illness. Luckily, help may be on the way. Baxter International (NYSE:BAX) released theresults from its phase II clinical trial on April 13th, demonstrating that their Gammagard product could help stop the loss of brain cells in Alzheimer’s patients. That’s phenomenal! This is a treatment that could stop, maybe even reverse, some of the progression of Alzheimer’s disease, and it’s already been tried in humans. It will likely be several years until Gammagard is ready to hit the market (there are still phase III trials to pass) but we have gotten closer to an effective means of slowing or stopping Alzheimer’s in its tracks, and that’s incredible news.
The recently completed Baxter study, which was performed in cooperation with the Weiss Cornell Medical Center, looked at 14 patients over 18 months using MRI scans to record the rate of brain cell loss. According to their press release, those patients on Gammagard experienced less loss of brain cells (measured by swelling in areas of the brain) than those patients on placebo. Cognition and function was also better for Gammagard patients than those on placebo. These results are pretty amazing. Losing fewer brain cells is high on my list of positive effects for any drug and preventing Alzheimer’s related memory and cognition loss is also damned important. According to Bloomberg, there were even some patients that showed noticeable reversal in Alzheimer’s symptoms. One patient, a pianist, was formerly only able to remember and play about four songs. After the 18 month trials, family members reported that the patient had started to learn new songs. That’s news that brings hope to Alzheimer’s patients everywhere and would certainly make selling Gammagard very easy.
The market for Alzheimer’s drugs is already in the billions. Aricept, from Pfizer, had sales in excess of $3 billion last year, and Forest Labs sold $950 million of their product, Numenda. The market is driven by the 30 million Alzheimer’s patients in the world, 5 million or so in the US.According to the CDC there may be around 13 million patients in the US by 2050. Medicare spent $91 billion in Alzheimer’s related expenses in 2005 alone. The world population is continuing to get older, and Alzheimer’s is an age-related disease. Overcoming it will be a major hurdle in our pursuit of longevity.
Gammagard is a immunotherapy product (intravenous immunoglobulin or IVIG) developed from thousands of human plasma donations. It’s been FDA approved (for immunotherapy) and on the market since the 90s in various forms. Many believe that Alzheimer’s may be caused by the buildup of amyloid plaque and related inflammation on the brain, and Gammagard contains amyloid fighting antibodies. In the phase II trials nurses traveled to the residences of  patients and gave them Gammagard intravenously with regularly scheduled check ups and brain scans to measure effect. Those on placebo were switched to the drug after six months.
According to Baxter, the recently completed phase II trial for Gammagard is the first that tracked the trifecta for Alzheimer’s treatment: neuro-imaging, cognition, and brain function. Baxter plans on continuing with two phase III trials, the first of which is already started, and the second will begin by late 2010. This second phase III trial will continue to use MRI scans. The first phase III trial will focus on cognition and function and is part of the Gammaglobulin Alzheimer’s Partnership (GAP) study. 360 patients at 35 sites across the country (12 more sites pending in the US and Canada) will be studied for 18 months to see how Gammagard affects the progression of Alzheimer’s Disease. GAP is still actively recruiting patients, and those interested can check their website for eligibility. Because these studies will take at least 18 months to run, the earliest we will see results is likely to be 2012 for the GAP study and 2013 for the other phase III trials. In other words, there are years before we could see Gammagard approved by the FDA.
That being said, it’s important to note that Baxter is not the only company developing an IVIG drug for Alzheimer’s. Octapharma has its own phase II trial for octagam, a product much like Gammagard in basic composition. According to ClinicalTrials.gov, Pfizer and GSK also have intravenous treatments for Alzheimer’s Disease in the pipeline, PF-04360365 and GSK933776 respectively, both of which are anti-amyloid, though not necessarily immunoglobulin. Despite the competition, Gammagard is arguably the closest of these products to obtaining FDA approval and introduction into the market though Baxter’s stock rise after its announcement on April 13th was surprisingly small.
alzheimers-baxter-stock
Baxter stock rose about $0.90 after the Gammagard announcement. Not bad, but not great.
If I was an Alzheimer’s patient, or a family member of one, I’d probably be very interested in getting my hands on this product now. And you can: Gammagard and other IVIGs are already on the market for other uses. Undoubtedly there will be some doctors and patients out there who decide to use them for off-label treatments of Alzheimer’s. I’m not a doctor so I can’t comment on whether or not that’s a good idea. I will say, however, that as remarkable as these early findings may be, the sample sets were very small: just 14 people. The phase III trials will have many more patients and large studies can often show complications or contradictions to smaller studies, so we shouldn’t consider this work proven as of yet. Still, even these early results are very exciting.
Obviously any positive results for a new Alzheimer’s drug is good news. It’s hard to know, however, if Gammagard (or other IVIG products) will be a catch-all therapy, or just one drug in a cocktail used to treat the illness. The latter is much more likely. While I applaud trials like this one, they are only part of a much larger suite of research that has to be performed in order for us to understand and defeat Alzheimer’s. We’ve seen how genetic insights are helping us determine the risks for the disease, and genomics may allow us to identify individuals at risk much earlier in their lives. I also have hope that with the billions in sales (and millions in research), we’ll eventually determine the exact cause and develop an outright cure for the condition. Until then, I wish the best to Baxter and Cornell in their clinical trials and urge them to develop this new weapon against Alzheimer’s as soon as possible.

Saturday, August 27, 2011

Alzheimers and Chromosome 21 Encoding



The Alzheimer’s Drugs You Still Can’t Get

by Drew Halley August 16th, 2010 | Comments (0)
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Twenty years ago, researchers made serious headway in the battle against Alzheimer’s disease (AD). They discovered a link between the brain damage in AD patients and plaque deposits in the brain – the so-called “amyloid hypothesis,” now the dominant explanation of the disease, was born. Today, two decades later, there are only four treatment options for AD patients. None of them attack or prevent the plaque deposits. None of them slow or stop the disease. Why not?
Not a single plaque-preventing drug has yet gained FDA approval. There are currently hundreds of drugs in development to combat the symptoms – and hopefully the causes – of AD. Many of these drugs are aimed at blocking the formation of beta amyloids, peptides that cause plaque deposits in the brains of AD patients. But are the plaques the cause of neuron loss? The amyloid hypothesis is still unproven, and not all research supports it. The FDA is holding the bar high: until a drug can not only show that it blocks plaque formation safely, but preserves cognitive capacity in AD subjects, none of these drugs will make it to market.
Testing whether or not a drug prevents cognitive degeneration can take years or decades – basically as long as takes for the disease to reach advanced stages. This presents pharmaceutical companies with a regulatory conundrum. Let’s say a company decides to test its drug on susceptible subjects before AD onset, catching the disease early and improving the likelihood of success. Clinical trials will take much longer – long enough for differences between subject groups to emerge.
The alternative approach is the one being taken by Bristol-Myers Squib, which is currently testing its new drug BMS-708163. BMS is testing the drug on early-stage patients, which means their trials will show results much faster than if they had tested subjects without any symptoms. But by waiting until the disease has already progressed into its early stages, they run the risk that their subjects’ degeneration has advanced beyond the period when the drug could have helped. Add in competition with other companies racing for the prize, and you get an idea of the stakes involved.
AD causes severe brain degeneration compared with that of a healthy person.
The link between amyloids and AD was first proposed when the gene that codes for amyloid precursor protein was found on chromosome 21. People with Down syndrome have an extra copy of chromosome 21 (i.e. an extra copy of the amyloid precursor gene), and they commonly develop AD early in life. People with the E4 variant of the gene ApoE also produce more amyloid plaques, and it increases their susceptibility to AD. (We recently covered a study of how people react to hearing that they carry this risk variant).
So why is the FDA holding these drugs to such high standards? It isn’t clear that amyloid plaques are actually the cause of neuron death. A few years ago, an amyloid vaccine was tested on patients with AD; seven of the eight immunized patients died with severe dementia, even after partial or complete plaque removal. Scientists have been tweaking the amyloid theory since, and new treatments do hold promise. But the FDA is wary of approving a drug that clears plaque without stopping or slowing the disease itself.
AD currently affects over 26 million people, and those numbers are rising as the world population ages. A few years ago, a study at Johns Hopkins described a “looming global epidemic” of Alzheimer’s: the number of cases will quadruple within forty years, ultimately affecting 1 in 85 people globally. Whatever its cause, the slow progression of AD makes clearing drug treatments a terribly slow process – and one all the more important for the wave to come.

Vaccine Against Cocaine Addiction: controversial but interesting

Found an interesting article you need to know about. Little controversial but very interesting. A husband-wife doctor team has found a way to vaccinate drug addicts against many different addictive drugs including cocaine. Please read the following article. 

100 Living Geniuses (from Telegraph, UK)



Top 100 living geniuses

The Telegraph 7 Dec 2008

The Simpsons creator Matt Groening ranked number four in the list of living geniuses, but joint top of the list was British computer scientist Tim Berners-Lee.

British geniuses feature heavily in a recent list that notes the greatest living thinkers of our time - proportionately more than any other country.

The top 100 living geniuses was compiled by a panel of six experts in creativity and innovation from Creators Synectics, a global consultants firm.

The company emailed 4,000 Britons this summer and asked them to nominate up to 10 living people who they considered geniuses.

Each genius was then awarded scores out of ten against criteria which included: paradigm shifting; popular acclaim; intellectual power; achievement and cultural importance.

Examples of Notable British Living Genius


Tim Berners-Lee British Computer ScientistFrederick Sanger (British) ChemistAndrew Wiles (British) MathematicianDaniel Tammet (British) Savant & LinguistJane GoodallGeoffrey Hill - Poet
Tim Berners-Lee
(British) Computer Scientist
Frederick Sanger
(British) Chemist
Andrew Wiles
(British) Mathematician
Daniel Tammet
(British) Savant & Linguist
Jane Goodall
(British) Ethologist & Anthropologist
Geoffrey Hill
(British) Poet

The List
1= Albert Hoffman (Swiss) (died April 2008) Chemist
1= Tim Berners-Lee (British) Computer Scientist
3 George Soros (American) Investor & Philanthropist
4 Matt Groening (American) Satirist & Animator
5= Nelson Mandela (South African) Politician & Diplomat
5= Frederick Sanger (British) Chemist
7= Dario Fo (Italian) Writer & Dramatist
7= Steven Hawking (British) Physicist
9= Oscar Niemeyer (Brazilian) Architect
9= Philip Glass (American) Composer
9= Grigory Perelman (Russian) Mathematician
12= Andrew Wiles (British) Mathematician
12= Li Hongzhi (Chinese) Spiritual Leader
12= Ali Javan (Iranian) Engineer
15= Brian Eno (British) Composer
15= Damian Hirst (British) Artist
15= Daniel Tammet (British) Savant & Linguist
18 Nicholson Baker (American Writer
19 Daniel Barenboim (N/A) Musician
20= Robert Crumb (American) Artist
20=  Richard Dawkins (British) Biologist and philosopher
20= Larry Page & Sergey Brin (American) Publishers
20= Rupert Murdoch (American) Publisher
20=  Geoffrey Hill (British) Poet
25 Garry Kasparov (Russian) Chess Player
26= The Dalai Lama (Tibetan) Spiritual Leader
26= Steven Spielberg (American) Film maker
26= Hiroshi Ishiguro (Japanese) Roboticist
26= Robert Edwards (British) Pioneer of IVF treatment
26= Seamus Heaney (Irish) Poet
31 Harold Pinter (British) Writer & Dramatist
32= Flossie Wong-Staal (Chinese) Bio-technologist
32= Bobby Fischer (American) Chess Player
32= Prince (American) Musician
32= Henrik Gorecki (Polish) Composer
32=  Avram Noam Chomski (American)
Philosopher & linguist
32= Sebastian Thrun (German) Probabilistic roboticist
32= Nima Arkani Hamed (Canadian) Physicist
32= Margaret Turnbull (American) Astrobiologist
40= Elaine Pagels (American) Historian
40= Enrique Ostrea (Philippino) Pediatrics & neonatology
40= Gary Becker (American) Economist
43= Mohammed Ali (American) Boxer
43= Osama Bin Laden (Saudi) Islamicist
43= Bill Gates (American) Businessman
43= Philip Roth (American) Writer
43= James West (American)
Invented the foil electrical microphone
43=  Tuan Vo-Dinh (Vietnamese)
Bio-Medical Scientist 
49= Brian Wilson (American) Musician
49= Stevie Wonder (American) Singer songwritee
49= Vint Cerf (American) Computer scientist
49= Henry Kissinger (American) Diplomat and politician
49= Richard Branson (British) Publicist
49= Pardis Sabeti (Iranian) Biological anthropologist
49= Jon de Mol (Dutch) Television producer
49= Meryl Streep  (American) Actress
49= Margaret Attwood (Canadian) Writer
58= Placido Domingo (Spanish) Singer
58= John Lasseter (American) Digital Animator
58= Shunpei Yamazaki (Japanese) Computer scientist & physicist
58= Jane Goodall (British) Ethologist & Anthropologist
58= Kirti Narayan Chaudhuri (Indian) Historian
58= John Goto (British) Photographer
58= Paul McCartney (British) Musician
58= Stephen King (American) Writer
58= Leonard Cohen (American) Poet & musician

67= Aretha Franklin (American) Musician
67= David Bowie (British) Musician
67= Emily Oster (American) Economist
67= Steve Wozniak (American) Engineer and co-founder of Apple Computers
67= Martin Cooper (American) Inventor of the cell phone

72= George Lucas (American) Film maker
72= Niles Rogers (American) Musician
72= Hans Zimmer (German) Composer
72= John Williams (American) Composer
72= Annette Baier (New Zealander) Philosopher
72= Dorothy Rowe (British) Psychologist
72= Ivan Marchuk (Ukrainian) Artist & sculptor
72=  Robin Escovado (American) Composer
72= Mark Dean (American) Inventor & computer scientist
72= Rick Rubin  (American) Musician & producer
72= Stan Lee (American) Publisher

83= David Warren (Australian) Engineer
83= Jon Fosse (Norwegian) Writer & dramatist 
83= Gjertrud Schnackenberg (American) Poet
83= Graham Linehan (Irish) Writer & dramatist
83= JK Rowling (British) Writer
83=  Ken Russell (British) Film maker
83= Mikhail Timofeyevich Kalashnikov (Russian) Small arms designer
83= Erich Jarvis (American) Neurobiologist

91=.  Chad Varah (British) Founder of Samaritans
91= Nicolas Hayek (Swiss) Businessman and founder of Swatch 4
91= Alastair Hannay (British) Philosopher

94= Patricia Bath (American) Ophthalmologist 
94= Thomas A. Jackson  (American) Aerospace engineer
94= Dolly Parton (American) Singer
94= Morissey (British) Singer
94= Michael Eavis (British) Organiser of Glastonbury
94= Ranulph Fiennes (British) Adventurer

100=.  Quentin Tarantino (American)  Filmmaker