ROAD TO THE CURE UPDATE DECEMBER 2016

We have a Material Transfer Agreement (MTA) with a large pharmaceutical company to affirm our efforts and findings in their laboratory. This process was agreed upon prior to their making a possible offer to ICBI. ICBI scientists shipped mice to this US pharma in July for eight weeks’ acclimatization in a facility nearby. The experiment was supposed to have been performed in September but was delayed due to reorganization at the pharmaceutical company where the Director of their Imaging Program, one of the champions for ICBI/Pharma collaboration was let go September 1st, along with numerous other employees. The new scientist responsible for conducting this study is working to familiarize himself with the SPECT scanner the Pharma has together with other aspects of the experiment. This Pharma has never imaged a mouse brain using a radiolabeled antibody, consequently the new scientist is insisting on using fivefold higher dose, of iodine-125 labeled-syn-SM for imaging a mouse brain, than what was proposed by in the initial Material Transfer Agreement. We are concerned that the capability of the Pharma’s scanner and the inexperience of the scientist assigned to our project may create an unsuccessful collaboration. Nevertheless, we are hoping that this Pharma conducts this experiment before the year ends with results that are as good as the one our Canadian partners obtained two years ago.

Therapeutic Efficacy of our Parkinson’s Drug  (alpha-Synuclein-SMART Molecule) We are happy to report that Parkinson’s-like mice treated with two and six doses of our alpha-synuclein-SMART Molecule showed significant reduction in the levels of pathogenic (disease causing) protein in their brain. These experiments support the therapeutic utility of our Parkinson’s drug. Dr. Angela Cone presented the therapeutic efficacy data at the Therapeutic Conference held by the Michael J. Fox Foundation (MJFF) in New York on October 24th. According to Angela, no one else presented data related to therapeutic effect of drugs on Parkinson’s disease at the MJFF conference. ICBI was the only company that demonstrated therapeutic utility of its drug in an animal model. However, there are some major conceptual differences between ICBI and the advisors of MJFF: 1) The Foundation’s emphasis is on the development of a diagnostic test for early diagnosis of Parkinson’s while ICBI’s focus is both diagnosis and therapeutic modification and the halting of Parkinson’s progression. Our drug is capable of diagnosing and halting the disease progression in animals. 2)The big difference, however, is in defining what forms of pathogenic alpha-synuclein should be targeted for diagnosis and therapy. Currently, according to Dr. Eliezer Masliah, one of the pioneers in the field, and many other scientists, there is no consensus whether a drug should target only oligomeric (oligo-, “a few” + -mer, “parts”) alpha-synuclein or total alpha-synuclein (monomer [a molecule that can be bonded to other identical molecules to form a polymer] and oligomeric forms) but MJFF’s advisors have come to the conclusion, perhaps prematurely,  that only oligomeric alpha-synuclein should be targeted.

We believe the targeting of oligomeric alpha-synuclein will only help patients with Lewy body disease but not Parkinson’s patients in whom the levels of both monomeric and oligomeric a-synuclein are elevated. Our drug targets all forms of alpha-synuclein in the brain of animals. It is our belief, supported by several publications, that the levels of both the monomeric and oligomeric alpha-synuclein are elevated in the case of Parkinson’s disease. Our approach is superior to what the MJFF believes in. Although we have the capability to develop a drug that will only target and clear Lewy bodies, we are not sure if that is going to be good for ICBI’s business, in that we have to individually manufacture and test two different drugs rather than one that can treat most patients. 3)Immediate Plans: Our plans are to take our drug to the patients. The following needs to happen before starting clinical trials: i) Drug needs to cloned and manufactured (9–12 months) ii) Submit an IND application with the USFDA for approval (3 months). ii) Conduct Phase-1 human trials (6–12 months).