Dr. Daniel Chain, Chairman and CEO of development-stage biopharmaceutical company Intellect Neurosciences Inc. and inventor of an antibody-based technology platform for the treatment of Alzheimer’s disease, predicts despite recent Big Pharma failures (New York Times: Lilly Halts Alzheimer’s Drug Trial), we are less than five years from an Alzheimer’s drug that treats the disease, not just the symptoms.
“I am confident that the first disease-modifying drugs will be on the market within the next five years with follow-on generation improved drugs with increased safety and efficacy also on the way. My confidence is based on the progress that has been made over two decades of intensive research resulting in our current understanding of the underlying root cause of Alzheimer’s disease and the preliminary, but so far encouraging, data starting to emerge from clinical trials regarding products currently in advanced development,” said Chain.
Chain is the inventor and patent holder for the ANTISENILIN® technology platform already licensed by Intellect to several major pharmaceutical companies with antibody products in late stage clinical trials. Notable examples of antibodies that possess the key features of the ANTISENILIN® approach are Ponezumab being developed by Pfizer and Bapineuzumab being co-developed by Pfizer and Johnson & Johnson, currently being tested in Alzheimer's Phase II and Phase III clinical trials, respectively.Chain envisions his team at Intellect will play a key role in developing an optimized product with improved efficacy and safety features compared to first generation antibodies for Alzheimer’s.
In addition, Chain predicts Intellect will develop a prophylactic vaccine, the holy grail of Alzheimer’s research, with the potential to delay or prevent onset of the disease. In contrast to most other small biopharmaceutical companies that are focused on single technologies, Chain’s approach is to develop a diversified technology and product pipeline which includes a number of products based on different mechanisms giving the company the strongest chance of success.
Indeed, the company’s most advanced internally developed product – a copper-binding molecule which was so far tested in Phase I trials –works by a completely different mechanism of action than the antibody approach.
Drug development takes more than a dozen years to get to FDA approval and requires at minimum a billion dollars of investment. Most drugs fail due to safety issues or lack of efficacy, which usually manifest in large-scale, late-stage trials.
When a major drug trial fails, everyone questions the hypothesis, in this case the amyloid approach, but Chain says it’s not a mistake in amyloid theory that contributed to the most recent setback, but the safety features of the drug in the trial, which made the patients worse and in some cases even increased the risk of skin cancer.
In an exclusive to BioMedReports.com after the Lilly announcement, Chain said, “An understanding of the background and the drug’s mechanism of action affecting the function of a physiologically important protein may be helpful to avoid casting the baby out with the bathwater.”
The Amyloid Hypothesis – ILNS Leading the Way
In 1906, Dr. Alois Alzheimer first noticed an “unusual disease of the cerebral cortex” during the autopsy of Auguste Deter, a woman in her 50s he was treating for behavioral symptoms and memory loss (today that would be called early onset Alzheimer’s). Her brain showed various abnormalities – a thinner than normal cerebral cortex and senile plaque, which had previously only been found in older people, as well as neurofibrillary tangles.
Senile plaques, of which beta amyloid protein is the chief constituent, are considered the hallmark pathological feature of Alzheimer’s disease, although it is now known that more toxic forms of amyloid exist in the cerebrospinal fluid which carries nutrients to the brain and debris away. The amyloid hypothesis is built around the theory that when the beta amyloid protein accumulates in the brain, it becomes toxic, damaging nerve cells. Being able to eliminate the toxic protein without disturbing the delicate ecosystem of the brain can slow the disease, stop progression or even prevent it if treatment begins early. Chain was first to identify a method of achieving this using highly specific monoclonal antibodies that bind only amyloid protein.
Alzheimer’s changes the whole brain – nerve cell death, tissue loss and over time, dramatic shrinkage which affects nearly all its functions – and there is no cure. Alzheimer’s disease hallmarks are loss of memory and other brain functions, like the ability to learn, communicate with language and behave appropriately.
At only three pounds, the brain is our most powerful organ. The brain is surrounded by a continuous flow of cerebral spinal fluid, which is responsible for carrying nutrients to the brain and debris away from it. In people 65 and over, an accumulation of beta amyloid in the brain is thought to result from the slowing of the cerebral spinal fluid flow, disrupting the delicate in-out balance of nutrients and toxins which can result in beta amyloid plaques, tangles and ultimately Alzheimer’s. Once the brain’s nerve cells are damaged by these plaques, the destruction is irreversible, so researchers are working to stop beta amyloid from accumulating before damage begins. Most current Alzheimer’s research is based around reducing amyloid, clearing it away from the brain and/or blocking its neurotoxicity.
Chain’s light bulb moment for him in 1996 was to pinpoint unique molecular signatures of beta amyloid that could be used by antibodies to latch on to the target without interfering with the metabolism or functions of the amyloid precursor protein (APP) which produces beta amyloid. The Intellect Neurosciences ANTISENILIN® technology platform is designed to promote the safe clearance of the toxic beta amyloid protein away from the damaged sites of the brain while minimizing potential for adverse effects that may result from less specific binding. Chain believes that the use of secretase inhibitors such as Eli Lilly’s Semagacestat – a gamma secretase inhibitor meant to block metabolism of APP – was flawed because gamma secretase also acts on additional proteins to APP thus interfering with important unrelated physiological processes.
“Intellect’s overriding philosophy and approach to Alzheimer’s treatments aim to develop efficacious methods to prevent beta amyloid accumulation and block neurotoxicity without compromising safety,” he commented.
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Who is Dr. Daniel Chain?
Dr. Daniel Chain was born in the UK and had a “normal” upbringing growing up first in Rome and, from the age of 8, in his father’s department of biochemistry at Imperial College in London. Chain’s father, Professor Sir Ernst Chain, Ph.D., discovered how penicillin could be used as an effective, life-saving antibiotic and shared the 1945 Nobel Prize in Physiology or Medicine with Dr. Alexander Fleming and Howard Florey. Chain’s mother, Dr. Anne Beloff, was a biochemist who made important contributions in understanding the connection between obesity and diabetes. Dr. Chain’s twin sister has a Ph.D. in education and lives in London and his brother is Professor of Immunology at University College London (and inventor of Intellect Neurosciences’ RECALL-VAX, an Alzheimer’s prophylactic) and a member of the Intellect Neurosciences Scientific Advisory Board.
After graduating with a degree in biochemistry in London, Chain moved to Israel in 1984 and earned his Ph.D. in biochemistry from the Weizmann Institute of Science under the supervision of the late Professor Shmuel Shaltiel, whom Chain acknowledges as his most important scientific mentor. “Like my father, Shmuel believed the only experiments worth doing are those to answer a real biological question as opposed to simply to generate lots of data - he encouraged me to think carefully before embarking on a series of experiments. I think it was Shmuel who helped build the ‘laboratory in my head’ which is largely responsible for my talents as an innovator.” Chain then joined the Center for Neurobiology and Behavior at Columbia University College of Physicians and Surgeons, under the direction of Dr. Eric Kandel, who, too, was later awarded a Nobel Prize for his research exploring the workings of memory.
Chain’s research focused on identifying the linkage between short-term and long-term memory. Elder colleague and world-renowned Alzheimer’s researcher Professor Blas Frangione at New York University encouraged him to explore the biochemical basis of Alzheimer’s, a contradiction to the research being done at the time mostly by pathologists post-mortem. In November 1996, Chain had an epiphany in regards to a method for reducing beta amyloid and in 1998 established his first company, Mindset BioPharmaceuticals in Israel, where he started his work on developing novel therapies for Alzheimer’s disease. Chain returned to New York in 2005 to establish Intellect Neurosciences.
Backed by a dozen years as CEO dealing with both private and public company investors and developing biopharmaceutical products, Dr. Chain brings significant senior management experience aided by a strong scientific background and focus on innovation. Dr. Giora Feuerstein, M.D., former Head of Discovery Translational Medicine at Wyeth and Pfizer, who recently joined Intellect as a key consultant, says, “Dr. Chain impressed me by his critical, objective and balanced scientific assessments that I personally appreciate and like. I am confident that, under this type of leadership, the company will meet its important objectives focused on the development of innovative drugs that will provide meaningful medical benefits via disease-modifying mechanisms along with maximum safety."
Chain spends most days dividing his time between public/investor relations, product/business development and researching competitive intelligence. As CEO of a small cap biopharmaceutical company, Chain tries to ensure that his company’s investors see the big picture: “The key value drivers at ILNS are: (1) an internal preclinical and clinical-stage pipeline backed by strong intellectual property; and (2) royalty-bearing licenses with major pharmaceutical companies covering products in late-stage clinical trials. This gives ILNS a diversified risk that is rarely seen in small biopharmaceutical companies.” In addition, Dr. Chain makes himself available to journalists and analysts to comment on all things Alzheimer’s, and where possible, draw attention to the important work being done at Intellect Neurosciences.
Chain is at the forefront of major Alzheimer’s treatment breakthroughs, and not a moment too soon – Alzheimer’s is a global health crisis and the statistics are staggering. Alzheimer’s Disease is a Global Health Crisis Today, there are five FDA-approved Alzheimer’s drugs treating the symptoms of Alzheimer’s, but no medications currently treat the disease (an estimated $20 billion market).
• 35 million people worldwide have Alzheimer’s – a number expected to nearly double in the next 30 years
• More than 50 percent of people with Alzheimer’s live in developing countries
• By 2025, that number will be over 70 percent
• U.S. Baby Boomers (people born between 1946 and 1964) will add 10 million Alzheimer’s patients per decade
• “Early onset” Alzheimer’s disease can affect people as young as 40
• An estimated 5.3 million Americans currently have Alzheimer’s disease
• Alzheimer’s disease is the seventh leading cause of deaths in the U.S. (while other causes of death have decreased, Alzheimer’s has increased more than 46% from 2000-2006)
• One in eight people aged 65 and older has Alzheimer’s
• There is a new case of dementia in the world every seven seconds
• Every 70 seconds, someone in America develops Alzheimer’s
• By 2050, that number will decrease to every 33 seconds
• Alzheimer's disease accounts for 50-80 percent of dementia cases
• People with Alzheimer’s live an average of eight years (some can live 20)
• $315 billion is spent worldwide treating Alzheimer’s
• $172 billion is spent in the United States alone
• 10.9 million unpaid caregivers in the U.S. give an estimated 12.5 billion hours of care (valued at $144 billion)
The Exorbitant Cost of Treating Alzheimer’s Disease
In the absence of effective treatments, the cost of caring for Alzheimer’s patients in the U.S. alone is exorbitant – almost $200 billion annually. In a new report from the Alzheimer’s Association, “Changing the Trajectory of Alzheimer’s Disease: A National Imperative (www.alz.org/trajectory),” the cumulative cost of care from 2010 to 2050 is expected to be more than $20 trillion (Alzheimer's Disease to cost United States $20 trillion over next 40 years). Chain says it’s imperative and clear that it would be less expensive to develop drugs that slow down the disease, rather than continuing to treat the symptoms alone.
• Total cost of care in the U.S. will soar from $172 billion in 2010 to more than $1 trillion by 2050
• Medicare costs will increase more than 600 percent, from $88 billion to $627 billion
• Medicaid costs will soar 400 percent, from $34 billion to $178 billion
• By 2050, nearly half (48%) of the projected 13.5 million Americans with Alzheimer’s will be in the severe stage of the disease when more expensive and intensive around-the-clock care is required
Assuming Chain is right and a breakthrough occurs in 2015:
• The number of people age 65 and older with Alzheimer’s would be reduced by 5.8 million in 2050 (down 43%)
• In 2050, the number of patients in the severe stage would be 3.5 million instead of the expected 6.5 million
• Annual Medicare savings would be $33 billion in 2020 and climb to $283 billion by 2050
• Annual Medicaid savings would increase from $9 billion in 2020 to $79 billion in 2050
Besides drug development, federal research funding is a must. Despite the obvious strain on an already precarious healthcare system, President George W. Bush cut Alzheimer’s research for the first time in history. Today, research studies that request government funding have a less than one in 10 chance of getting green-lighted.
“We need a significant increase in federal research funding. Investing in research now will cost our nation far less than the cost of care for the rising number of Americans who will be affected by Alzheimer’s in coming decades,” says Bill Theis, Ph.D., Chief Medical and Scientific Officer, on the Alzheimer’s Association website.
Since 1980, the Alzheimer’s Association has been the leading voluntary health organization in Alzheimer care and support and the largest private, nonprofit funder of Alzheimer research. The Association is working tirelessly to enact critical legislation. The National Alzheimer’s Project Act will create an integrated federal campaign to overcome Alzheimer's disease. The Alzheimer’s Breakthrough Act of 2009 will authorize $2 billion in research funding for Alzheimer’s disease.
The Health Outcomes, Planning and Education (HOPE) for Alzheimer's Act will provide Medicare reimbursement to increase the detection and diagnosis of Alzheimer’s disease and other dementias.
The Alzheimer’s Association needs your help in asking Congress to make Alzheimer's disease a national priority.
Sign the petition here: http://www.alz.org/whyisigned/
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