ROAD TO THE CURE UPDATE MAY 2018Category: Road to the Cure
Helplessness makes us susceptible to fall victims to the surroundings. This is exactly what happened to the numerous Parkinson’s disease patients who, due to the debilitation and frightening psychosis, felt helpless and became victims to Acadia’s Nuplazid, a drug approved by the FDA on a fast-tracked basis for the treatment of psychosis. According to CNN, FDA approved Nuplazid against the warning of the physician, Dr. Paul Andreason, who led the FDA’s medical review board. Dr. Andreason had warned that patients taking the drug (Nuplazid) during the clinical trials experienced serious outcomes, including death, at more than double the rate of those taking the placebo. The company’s limiting testing had not convinced Dr. Andreason that the benefits outweighed the risks.
Nuplazid entered the market in June 2016. Shortly after the drug release, patients’ family members, doctors and other health care professionals started reporting adverse events possibly linked to the medication, including hallucinations, psychosis, falls, insomnia, nausea, fatigue and deaths. By June 2017, the number of deaths had risen to at least 500. “This is almost unheard of, to have these many deaths reported”, said Diana Zuckerman, Founder and President of the non-profit think tank The National Center for Health Research, adding that because reports are voluntary, potential problems may be underreported. “You just don’t see this with most new drugs—you don’t see all these reports—so you have to take it seriously”.
No matter what Acadia says about the safety of Nuplazid, the facts speak louder than the safety claims made by the company. The lesson from this CNN report is that all patients and their family members must use caution before using drugs approved by the US FDA on an accelerated basis. Before taking any drug, it is important to ask the physician about the side effects and benefits. If the risks outweigh the benefits, one should think twice before using such drugs.
The San Diego Biotech Company, ICB International, Inc., (“ICBII”), has set up collaboration with the UCSD to conduct experiments with Parkinson’s transgenic mice. The goal of these collaborative experiments is to study the effect of chelators on the blood-brain barrier (BBB) permeability of SMART Molecules. If chelators do not retard BBB permeability, then ICBII can use UCSD’s radiology facility to scan the brain of animals as opposed to sending samples to Canada, which were retained 50% of the time by Canadian customs.
One of the pharmaceutical companies has agreed to collaborate with ICBII to develop commercial products for halting/reversing Parkinson’s, Alzheimer’s and MSA diseases. The terms of the collaboration will be negotiated in the coming weeks but ICBII management is looking forward to a long-term relationship with this pharma that has been in the business of commercializing drugs for the symptomatic relief of the brain disease.
The Company has developed breakthrough technology comprising of antibody mimics, referred to as SMART Molecules (SMs), to overcome the hurdles of the blood-brain barrier (BBB). The BBB is a physical barrier that protects the brain from the blood-born pathogenic. The BBB does not allow the access of nearly 98% of all pharmaceuticals to the central nervous system (CNS), which is one of the main reasons why there are no curative treatments for most of the CNS diseases. The good news is that ICBII has solved this insurmountable problem. Some of the unique attributes of SMs technology are:
- Allows quantitation of CNS pathogenic proteins in live animals, which is a historic invention.
- Third parties have verified the BBB permeability of SMs.
- Engages and destroys pathological proteins in the brain of animal models of Alzheimer’s and Parkinson’s diseases.
- Is a platform technology with applications to brain and non-brain diseases.
- Ready for human testing
- The Company is now seeking funds to scale up the production of its SMs for human clinical trials.