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SHERMAN BIOTECH

SHERMAN BIOTECH. SHERMAN BIOTECH. Drug Development for Anxiety in Fragile X and Autism Diagnostic Test Development for Fragile X and Autism. SHERMAN BIOTECH. Drug Development for Anxiety in Fragile X and Autism. SHERMAN BIOTECH. Drug Development for Anxiety in Fragile X and Autism

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SHERMAN BIOTECH

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  1. SHERMAN BIOTECH

  2. SHERMAN BIOTECH • Drug Development for Anxiety in Fragile X and Autism • Diagnostic Test Development for Fragile X and Autism

  3. SHERMAN BIOTECH • Drug Development for Anxiety in Fragile X and Autism

  4. SHERMAN BIOTECH • Drug Development for Anxiety in Fragile X and Autism • Lead drug SB15

  5. SHERMAN BIOTECH Fragile X (FXS) Autism (ASD) • 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” Behavioral disorder, varying degrees of severity Genetic (multiplechromosomes) ~1 in 200 Abnormal motor, sensory and communication Anxiety Other autistic behaviors

  6. SHERMAN BIOTECH Anxietyin 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”

  7. Small Molecule Cell-Cell Signaler Glutamate hippocampus Anxiety areas in the brain

  8. Small Molecule Cell-Cell Signaler Glutamate SB15 ANXIETY ANXIETY DECREASED hippocampus Anxiety areas in the brain

  9. 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

  10. 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)

  11. 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

  12. SHERMAN BIOTECH The Drug Development Process TASK STATUS Drug Discovery Completed Optimize Delivery In Progress Animal Studies 6 - 9 Months Human Studies 2 Months* * Clinic identified Patients recruited

  13. 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%

  14. SHERMAN BIOTECH Experienced Resources: Albert Einstein Medical School, Columbia University Scynexsis Contract Research Laboratory Fragile X Clinic, Rush Medical School Fragile X Foundation

  15. 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

  16. 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

  17. SHERMAN BIOTECH Latest Research May Provide a Test

  18. Glutamate: Chemical Signaler hippocampus Anxiety areas in the brain

  19. Glutamate SB15 Glutamate receptor Signal enzymes Diagnostic Test FXMP Protein Normal IMPROVEMNET Fragile X

  20. SHERMAN BIOTECH Diagnostic Development Process TASK STATUS Test Discovery Completed In Progress Laboratory Version POC Version 6 - 9 Months* OTC Version 6 Months** * Pan Probe Inc ** Overlapping

  21. 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

  22. 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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