According to Ram Bhatt, PhD, CSO “ICBI continues to make progress in bringing its Parkinson’s drug nearer and nearer to closing the gap between today and delivering it to the people…”
It is very encouraging news that the U.S. Food and Drug Administration (FDA) has approved a new drug called Xadago (safinamide) from Newron Pharmaceuticals for people with Parkinson’s disease (PD) who are taking levodopa but experiencing “off” episodes. “Off” episodes are times when Parkinson’s symptoms, such as tremor or difficulty walking, return despite medication. They are more common as the disease progresses. Xadago is indicated as an add-on therapy for those taking levodopa/carbidopa. The safety and efficacy of Xadago were evaluated in two clinical trials that included 1,194 participants. These studies showed that, compared to people taking a placebo, those on Xadago experienced more beneficial “on” time (when PD symptoms are reduced) and less “off” time (when PD symptoms are increased).
This new therapy is a monoamine oxidase (MAO)-B inhibitor, a type of drug that allows the remaining dopamine to function for a longer period of time. Other types of MAO-B inhibitors that are FDA approved to treat PD include selegiline (Eldepryl, Zelapar, EMSAM) and rasagiline (Azilect).
Parkinson’s is a relentless disease STILL without a cure. The newly approved drug is an excellent scientific and medical contribution to the Parkinson’s world. However, it is not a curative treatment but rather a treatment that, like Levodopa, will provide short-term symptomatic relief. Sadly, in spite of several decades of hard work and billions of dollars invested into drug development the disease halting therapies for most of the neurodegenerative diseases remain elusive. We are no closer to a cure than we were three decades ago. One of the main reasons for the lack of curative therapies for Parkinson’s and other central nervous system diseases is the presence of a physical barrier in the brain that acts as a security guard to filter what enters the brain, or not, from the blood. Known as the blood-brain barrier (BBB), this barrier has been an insurmountable barrier ever since the origin of mankind, although it was discovered in 1885. It is unfortunate that for nearly a century or more the scientific and medical community did not appreciate the role of the BBB. The pharmaceuticals and the academia went on developing drugs without appreciating the hurdles due to the BBB that led to failure of several clinical trials in the last decade. Such failure will continue to occur until the global scientific community solves the problem of the BBB impermeability so that the drug can reach the central nervous system.
During the last several decades, several pharmaceutical companies undertook research programs to conquer the BBB. The big pharmaceutical company is risk adverse like most investors. Their comfort zone was to work on what already has worked in their hands. Consequently, these companies largely focused on old, classical mouse monoclonal antibodies (mAbs) and used them as immunotherapy drugs for curing or halting the progression of Parkinson’s and Alzheimer’s disease during the last decade. Since the mouse mAbs have a very poor brain uptake it was not a surprise that clinical trials by big pharmaceuticals such as Pfizer, J&J, Eli Lilly and Roche all failed.
Founded in 2008, the founders of ICB International, Inc., (“ICBI”), a La Jolla, CA based biomedicine company, realized that a paradigm shift is needed in the scientific process to solve the BBB problem. To avoid past mistakes of the scientific community for nearly half the century, the scientists at ICBI followed an out-of-the-box approach, which initially met with a great amount of skepticism by the scientific community and investors. ICBI scientists developed a technology, referred to as SMART Molecules (SMs) technology. By 2103, the SMs technology was proven to unequivocally cross the BBB in two mouse models by third parties that consisted of reputable scientists from two universities. During the last two years, the SM technology has been shown to detect the CNS pathogenic proteins by brain imaging (disease diagnosis) and halt the progression of Parkinson’s disease in animals. Thus, ICBI is the first Company to develop potential non-invasive early diagnoses and therapies for debilitating diseases of the CNS. While animal testing can be performed by small quantities, human testing requires large quantities in kilogram scales
Drug development is a long, expensive and convoluted process. It is naïve to expect to develop a drug with few hundred thousand or millions of dollars. ICBI believes that once it has developed its drug manufacturing process, it will become a target for investment by a big pharmaceutical.
If you meet certain qualifications, you too may be able to take part in this “history-making” science. You can still get in at ground floor if that appeals to you. Or you can continue waiting until SOMEONE ELSE handles this pandemic. Please get in touch with Jo Rosen at Parkinson’s Resource Organization with whom we are in constant communication, updating her on our progress, while learning from her why it is so important to continue working to eradicate this horrific disease.
IMAGINE a world without Parkinson’s or Alzheimer’s disease. Just Imagine.