PREPARING FOR HUMAN CLINICAL TRIALS AND CNS DISEASE DETECT.. · Parkinson's Resource Organization

PREPARING FOR HUMAN CLINICAL TRIALS AND CNS DISEASE DETECTION AND MONITORING HAS BEEN UPENDED BY THE NOVEL CORONAVIRUS 19

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UPDATE ON THE ROAD TO THE CURE
A REAL-TIME SCIENCE REPORT

The year 2020 has been a challenging year for most businesses and families worldwide. Even with a state mandated lockdown of 7-8 months, ICBII has continued to strive to bring its technology closer to clinical trials and to expand its IP portfolio, which is the critical factor in enhancing ICBII's long term value.

Our Parkinson’s drug has exhibited dose dependent therapeutic effects in mice. This is a critical requirement for any therapy.  The next important step is to determine the safe and effective dose of our Parkinson’s drug (α-syn-SM) for human clinical trials. Use of healthy humans to conduct this study would be forbiddingly expensive.  We are planning to first study the pharmacokinetics and pharmacodynamics of our drug in non-human primates. A major pharmaceutical company, Dr. Bhatt’s former employer, approached ICBI to explore collaboration and in that communication stated that, in the absence of human clinical data, testing of the SMART molecule in primates is required.

The basic premise that drives ICBII is that the global pharmaceutical industry has spent hundreds of billions of dollars over the last 3-4 decades and still has not developed a technology to clinically diagnose (and monitor) CNS diseases until postmortem due to Blood-Brain-Barrier impermeability. We had previously demonstrated the ability of our SMART Molecules to diagnose CNS diseases in animals by a simple brain scan after a tail-vein injection of iodine-125 labeled SMART Molecule. This was an unprecedented achievement. The experiment conducted by the Center for Molecular Imaging Sherbrook (CMIS), Canada, required scanning the animal brains 24 hours post injection of the radiolabeled drug. To translate this test to humans, ICBII needs to shorten the duration of disease detection and monitoring from 24 to 2-4 hours to reduce human exposure to radiation. 

During the lockdown period from February 25 till September 7, 2020, ICBI designed seven variations/analogs of α-Syn-SM to test whether one or more analogs will assist in diagnosing and monitoring disease progression or regression in a medically acceptable period for humans, which should be less than 4 hours. We outsourced the development of DNA vectors for these seven analogs and these DNA vectors were constructed for ICBI in November 2020. These vectors are being expressed in E. coli and we have already successfully expressed and purified one of these analogs.  After expressing and purifying the SMART Molecules (α-Syn-SMs) from the remaining six vectors, we will study their brain uptake and potential to detect CNS pathogen within 1to2 hours post injection. This will be a significant step towards developing a non-invasive human test for CNS disease diagnosis and monitoring therapy affects.  

Unfortunately, COVID-19 has upended our routine. In addition, everyone is concerned about the rising COVID-19 cases throughout the US. Escalating COVID-19 cases in San Diego mandated ICBI to close the laboratory beginning December 22. We will resume our work after the New Year.

WOULD YOU LIKE TO HELP get ICBII’s 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 ICBI directly through their website http://icbii.com/ or by phone 858-455-9880, or contact Jo Rosen at PRO for a personal introduction to the scientists.

IMAGINE the world without Parkinson’s, MSA, or Alzheimer’s disease. JUST IMAGINE.

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Updated: August 16, 2017