ROAD TO THE CURE UPDATE FEBRUARY 2016 · Parkinson's Resource Organization

ROAD TO THE CURE UPDATE FEBRUARY 2016

Category: Road to the Cure

Generation of Parkinson’s-Like Transgenic Animals for Pharmacodynamics Study –

Last month ICBI scientists reported that they’ve generated an adequate quantity of their Parkinson’s drug to conduct pharmacodynamics (the study of the biochemical and physiological effects of drugs on the body or on microorganisms or parasites within or on the body and the mechanisms of drug action and the relationship between drug concentration and effect) and toxicity (the degree to which a substance can damage an organism) studies in several dozen transgenic mice. The Company has been working with Dr. Sylvie Ramboz of PsychoGenics, New York, to streamline the protocol to conduct these experiments. We expect the final protocol to be ready by the end of this month.

While the protocol is being developed, PsychoGenics is breeding Parkinson’s-like transgenic mice for the pharmacodynamics study. We believe that by May-June of this year, we will be able to start these experiments. We are pleased with our collaborations with Dr. Ramboz and you will too when you read an excerpt from her biography: After obtaining her master of neuromolecular genetic training at the Institute for Genetics and Cellular and Molecular Biology, Strasbourg (France), Dr. Ramboz went on to a neuropharmacological training at Columbia University. There she pursued her PhD thesis under the supervision of Dr. Rene Hen on understanding the genetic and behavioral roles of 5-HT1A and 5-HT1B receptors by generating conditional and inducible animal models. Thereafter Dr. Ramboz joined the biotechnology industry by starting up Memory Pharmaceuticals, focusing at that time on Dopamine receptors and their roles in aging; then Xenogen Biosciences Corporation by generating and characterizing animal models for CNS diseases. Currently, Dr. Ramboz brings more than 20 years of expertise in neuromolecular, neuropharmacology and CNS behavior and leads the Neurodegenerative Disorders program at PsychoGenics, where she is responsible for the scientific, operational and business development in the spinal muscular atrophy, muscular dystrophies, Huntington and Parkinson disease projects. Because we’re reporting to you in “real time” it is important for readers and investors to note that the special mice used in testing and optimizing therapies for neurodegenerative diseases are simply not available “off the shelf.” The mice have to be bred and allowed to age several months before they are ready for use.  This mother-nature controlled process takes time and there is no magic to produce these transgenic mice in a hurry. Simultaneously, ICBI scientists are also breeding transgenic mice for use by one of the big US pharmaceutical companies that has signed a Material Transfer Agreement for the purpose of validating the ICBI technology at its headquarters and to explore business relations with ICBI.

As much as no one likes waiting, there is no way to expedite the growth of these transgenic mice. What makes this process very complex and also nerve wracking is that because of neurodegeneration, transgenic mice are short lived. In addition, due to Parkinson’s disease, the parents either neglect their pups or mutilate them soon after birth, which makes the breeding process extremely slow. There are several hurdles in breeding transgenic mice and these hurdles are also mainly due to mother-nature. After four or five generations, these mice start losing the expression of the transgenic gene. While these issues are not discussed in any text book, nor reported by investigators who develop these transgenic strains of mice, we recently found that with successive breeding, the transgenic mice we obtained through the Michael J. Fox Foundation slowly lost their expression of human alpha-synuclein. That is why, we now have to breed more transgenic mice for testing our therapeutic drugs. Notwithstanding the above paragraphs, ICBI is extremely optimistic of meeting it’s time lines as outlined in last month’s update. We are working vigorously to bring the “Road to the Cure” to fruition. But saying that means we need your help as well.

THE ICBI Plans for 2016 ContinuedWith help from our existing investors and our soon-to-be ICBI investors, we believe 2016 is likely to be a great year for ICBI, its investors and the Parkinson’s world. That is why we are vigorously working to: Fulfill the Agreement with the big US pharmaceutical company in conducting validation of the ICBI technology in the hands of their scientists at its headquarters.  Currently the only bottleneck is the mice that are being bred; Continue raising the needed cash to conduct the key experiments discussed above. Upon completion of these two elements alone will grow ICBI’s global recognition virally. We repeat, while no one knows the future, we are confident that our SMART Molecules drugs will have exquisite therapeutic efficacy. There is scientific evidence that conventional mouse monoclonal antibodies with very poor (0.1%) brain uptake can exhibit some beneficial therapeutic effects in animals, albeit after a long treatment time. Therefore, ICBI’s SMART Molecules have demonstrated 150 folds higher brain uptake than the mouse conventional monoclonal antibodies and believed to exhibit much superior therapeutic index to conventional mouse antibodies in a “short” treatment time. If you would like to participate in helping us fulfill our goals, which then become even more of your goals, please get in touch with Jo Rosen at Parkinson’s Resource Organization. With and through Ms. Rosen she will help in getting you a personal tour of the laboratory and an introduction to the leading scientists. These are very exciting times for us. We look forward to including you in our family of investors and supporters.

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Updated: August 16, 2017