Daniel Chain,Ph.D, the son of a Nobel Prize Winner and a distinguished neurobiologist himself, woke up one Sunday night 1996 and had a sudden inspiration– “Why not monocolonal antibodies?”
Chairman and chief executive officer of Manhattan-based Intellect Neurosciences, Dr. Chainwas interested in finding an innovative medication that can slow down, arrest and ultimately prevent Alzheimer’s disease – a devastating condition afflicting 30 million people worldwide. Contrary to current drugs on the market, which only treat symptoms, Dr. Chain’s aim was to create a new class of disease-modifying Alzheimer’s drugs that attack the underlying pathologies.
Moncolonal antibodies are a type of protein made in the laboratory designed to find and bind to a specific substance. Could a monoclonal antibody be developed that would latch on to amyloid, a dense deposit of protein found as plaques on the cells and nerves of Alzheimer’s patients at autopsy? There is no unanimous agreement that amyloid plaques are the cause of the condition but may be just a symptom or an extraneous factor.
Amyloid plaques were first noted by Dr. Louis Alzheimer’s in 1906 . The main constituent of the plaques is the Beta Amyloid protein which is comprised of fragments of a much larger protein called the Amyloid Precursor Protein (APP) implicated in regulating numerous physiological functions in the body. Beta Amyloid can accumulate for different reasons in the brain. The naturally sticky fragments form clumps that increase in number and density until eventually, the clumps deposit as insoluble plaques onto the surface of nerve cells. Are these plaques toxic? Are they beneficial? Do their roles change at different stages of the disease? As the plaques mature in the brain do they trigger inflammation which damages the cells causing them to die?
Toxic Substance Floating In Brain Fluid
Dr. Chain now believes that there is a toxic substance floating around in brain fluid that is a precursor to amyloid clumps and plaques.
“Perhaps,” he reasons, “the plaques of hardened amyloid found on the brain cells of Alzheimer’s patients may be the way the brain actually protects itself from the toxic amyloid precursor.”
Drug Companies At Work On The New Type of Drug
He says he decided to develop a method of harnessing certain monoclonal antibodies that he believes can be used to render the precursor harmless and thus prevent or improve Alzheimer’s destruction of the brain cells.
Dr. Chain was successful and he patented the technique he developed for amyloid precursor seeking monoclonal antibodies. He calls it Antisenilin for anti-senility. His invention is currently being used by several of the world’s largest pharmaceutical companies which have taken licenses to Dr. Chain’s patents from which Intellect Neurosciences stands to obtain royalties from sales if and when the drugs are approved by the FDA . The most advanced product, Bapineuzumab, is in Phase 3 clincal trials involving several thousand Alzheimer’s patients world-wide. Bapineuzumab is being co-developed by Wyeth/Pfizer and Johnson & Johnson. Dr. Chain’s patents have already been granted in Europe, Japan, China and elsewhere
Dr. Chain points out there are two basic types of Alzheimer’s. One that occurs in 5 to 10 percent relatively early at 40-50 years and invariably has a genetic pre-disposition carried in families. The other starts later– about 65 years and up –and has known and unknown causes.
He said the tests first conducted with bapineuzumab, involved a small group about 250 patients: “The researchers did not separate out those with the gene for the disease and those who developed Alzheimer’s later in life. Results did seem to indicate that those who developed it later in life were benefited by the drug but not those who carried the gene.”
Studies involving several thousand people –separating the two types of Alzheimer’s—are now underway.
Bapineuzumab May Be On The Market Within Three Years
Dr. Chain said he hopes that within three years, bapineuzumab will be on the market.
What about side-effects?
So far, he said, he, there is some edema—(swelling) –but it goes away and in lower doses it does not occur at all.