ICBI UPDATE: CLINICAL TRIALS IN ALZHEIMER'S AND PARKINSON'S DISEASE ARE FAILING: WHAT CAN BE DONE?Category: Road to the Cure
A Real-Time Science Report
CLINICAL TRIALS IN ALZHEIMER’S AND PARKINSON’S DISEASES ARE FAILING: WHAT CAN BE DONE?
With no drugs that can stop the progression of the disease and hundreds of clinical trials failing, where is the hope for people with Alzheimer’s and Parkinson’s?
As the global population is living longer, diseases of the central nervous system (CNS) such as Alzheimer’s and Parkinson’s have become the biggest diseases of the 21st century. But despite the efforts of science, as of today, no drug is available that can stop the progression of the disease. This is definitely not for a lack of trying. Over several hundred clinical trials were run between 2002 and 2014 but without success with any of the tested drug to stop or slow down the disease. The situation has not improved much since then. In the last few years, Merck, Pfizer, J&J, Eli Lilly and Roche have all failed large Phase 3 trials in Alzheimer’s disease.
One of the most common explanations given to the failures seen in clinical trials has been that it might be already too late to treat patients when they already have advanced symptoms of the disease, and that trials should be run in people with milder, earlier symptoms. Other common explanation given in case of failure of Alzheimer’s clinical trials has been the blame on “amyloid hypothesis’, which may not be the disease-causing hypothesis.
But there might be something else behind these failures. These trials were conducted using mouse monoclonal antibodies which are large molecules biologics. Below is what is known about large molecules:
“Biologics are large molecule drugs that do not cross the blood–brain barrier (BBB), and past central nervous system biologic drug development programs were pursued in the absence of BBB drug delivery technology. Few biologics have been FDA approved for brain disease, and these approved drugs do not cross the BBB”, William Pardridge, Bio Drugs, 31, 503 (2017). If drugs do not reach the CNS, expecting a cure for brain diseases has been not only irrational but also a fool’s paradise. Consequently, perhaps several hundred billion dollars have gone down the drain casting a gloom over the entire CNS Research and Development Program all over the world.
Where Do We Go From Here? Thankfully, a small biotech company ICB International, Inc., (“ICBII”), in La Jolla, CA has developed technology to deliver drugs across the BBB. Their unique approach has been verified by third parties. The table below shows what ICBII scientists have done to address the key issues which led to the failure of past clinical trials conducted by big pharmaceutical companies during the last decade.
Good News: The BBB permeable technology and its successful applications in animal models to stop and reverse Alzheimer’s and Parkinson’s diseases positions ICBII in a unique situation to take its drugs from laboratory to patients in a way no one has done so far. The Company has accomplished all this with $5.5M, which others haven’t accomplished even spending $Billions. With as little as additional $7M to $10M, ICBII plans to conduct Phase-1 clinical trials on its Parkinson’s drug.
WOULD YOU LIKE TO HELP get their drugs to market faster? The joy of being a part of this historical event can be had by helping ICBI find the funds to bring these trials to fruition through your investing, and by finding others with the financial ability and humanitarian mindset to accomplish the - until now - impossible. Please contact Jo Rosen at 760-773-5628 or jorosen@Parkinsonsresource.org or by contacting ICBI directly through their website http://icbii.com/ or by phone 858-455-9880.
IMAGINE the world without Parkinson’s, MSA or Alzheimer’s disease. JUST IMAGINE.