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SHERMAN BIOTECH
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Drug Development for Anxiety in Fragile X and Autism Diagnostic Test Development for Fragile X and Autism
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SHERMAN BIOTECH Drug Development for Anxiety in Fragile X and Autism
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SHERMAN BIOTECH Drug Development for Anxiety in Fragile X and Autism –Lead drug SB15
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SHERMAN BIOTECH Fragile X (FXS)Autism (ASD) Behavioral disorder, varying degrees of severity Genetic (multiple chromosomes) ~1 in 200 Abnormal motor, sensory and communication Anxiety Other autistic behaviors Behavioral disorder, varying degrees of severity Genetic (X chromosome) ~1 in 2000 Abnormal motor, sensory and communication Anxiety Autistic-like behaviors “Most common known cause of autism”
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SHERMAN BIOTECH Anxiety in Fragile X and Autism Significantly interferes with social development and learning Controlling anxiety can greatly improve therapies Current anti-anxiety drugs are broad acting and usually ineffective Valium, Prozac, amphetamines, anti-psychotics etc “Hit or Miss”, singly or in combination Targeted drugs are needed SB15 - a targeted “Glutamate Blocker”
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Glutamate Anxiety areas in the brain hippocampus Small Molecule Cell-Cell Signaler
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SB15 ANXIETY DECREASED Anxiety areas in the brain hippocampus Glutamate Small Molecule Cell-Cell Signaler
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SHERMAN BIOTECH Summary Glutamate transmits signals between nerve cells Glutamate is in parts of the brain that have a role in anxiety Uncontrolled Glutamate stimulation is associated with anxiety SB15 blocks Glutamate and decreases anxiety
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SHERMAN BIOTECH SB15 Summary to date Inhibits anxiety in animals and humans Mechanism of action is targeted and different from antidepressants, amphetamines antipsychotics etc Non-sedative, non-muscle relaxant, non addictive and no interaction with alcohol Easily synthesized ($ 0.1- 0.3 / dose)
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SHERMAN BIOTECH SB15 Challenges Short life in blood, variation in patients Solutions Exist Controlled / Prolonged release capsules Targeted release to brain Skin patch development to prolong release Drug stabilization
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SHERMAN BIOTECH The Drug Development Process Drug DiscoveryCompleted In Progress 6 - 9 Months 2 Months* TASKSTATUS Optimize Delivery Animal Studies Human Studies * Clinic identified Patients recruited
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SHERMAN BIOTECH Sales Projections* Fragile X 100,000 diagnosed 50% will take drug $20 / day 50,000 x $20 x 365 = $365 M / yr. Autism 1,200,000 diagnosed Off-label usage ?% $20 / day 600,000 x $20 x 365 = $4,380 B/yr Sherman Biotech will licenses the drug to a large pharmaceutical company for a percentage of gross sales. 10-15%
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SHERMAN BIOTECH Experienced Resources: Albert Einstein Medical School, Columbia University Scynexsis Contract Research Laboratory Fragile X Clinic, Rush Medical School Fragile X Foundation
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SHERMAN BIOTECH Drug Development for Anxiety in Fragile X and Autism Diagnostic Test Development for Fragile X and Autism –Hospital Laboratory –Point Of Care –Over The Counter
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SHERMAN BIOTECH The Need for a Screening Test for Fragile X and Autism Diagnosis is based on complicated behavioral evaluation May be delayed 2-3 years after birth Can be confused with other disorders, e.g., ADD, ADDH etc Genetic test for fragile X is expensive, restricted and under-utilized Most families want to know* * Various studies
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SHERMAN BIOTECH Latest Research May Provide a Test
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Glutamate: Chemical Signaler Anxiety areas in the brain hippocampus
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Normal Glutamate receptor FXMP Signal enzymes Protein Fragile X Diagnostic Test SB15 IMPROVEMNET
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SHERMAN BIOTECH Diagnostic Development Process Test DiscoveryCompleted In Progress 6 - 9 Months* 6 Months** TASKSTATUS Laboratory Version POC Version OTC Version * Pan Probe Inc ** Overlapping
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SHERMAN BIOTECH Drug and Diagnostic Development Expertise David Schwartz, PhD, Chief Science Officer Drug and Diagnostic Test Development Experience Sam Hopkins, PhD, Advisor Drug Development Experience (FDA Pre-Clinical) Clive Taylor, MD, PhD, Advisor Chairman, Department of Pathology, USC Medical School SHUIJE CIU, MD,PhD President, Pan Probe Inc
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SHERMAN BIOTECH Clinical Trial Expertise Elizabeth Berry-Kravis, MD, PhD Founder, Fragile X Clinic, Rush Medical Center Sue Ellen Krause, PhD Consultant, Fragile X Clinic, Rush Medical Center Sam Hopkins, PhD, Advisor Drug Development Experience (FDA Phase 1-3)
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