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 – Lead drug SB15 SHERMAN BIOTECH Fragile X (FXS) Behavioral disorder, varying degrees of severity Genetic (X chromosome) ~1 in 2000 Abnormal motor, sensory and communication Anxiety Autistic-like behaviors Autism (ASD) Behavioral disorder, varying degrees of severity Genetic (multiple chromosomes) ~1 in 200 Abnormal motor, sensory and communication Anxiety Other autistic behaviors “Most common known cause of autism” 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” Glutamate Small Molecule Cell-Cell Signaler hippocampus Anxiety areas in the brain Glutamate Small Molecule Cell-Cell Signaler ANXIETY DECREASED hippocampus Anxiety areas in the brain 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 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) • • 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 SHERMAN BIOTECH The Drug Development Process TASK Drug Discovery Optimize Delivery Animal Studies Human Studies STATUS Completed In Progress 6 - 9 Months 2 Months* * Clinic identified Patients recruited 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% SHERMAN BIOTECH Experienced Resources: Albert Einstein Medical School, Columbia University Scynexsis Contract Research Laboratory Fragile X Clinic, Rush Medical School Fragile X Foundation 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 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 SHERMAN BIOTECH Latest Research May Provide a Test Glutamate: Chemical Signaler hippocampus Anxiety areas in the brain Glutamate Glutamate receptor Signal enzymes Diagnostic Test FXMP Protein Normal IMPROVEMNET Fragile X SHERMAN BIOTECH Diagnostic Development Process TASK Test Discovery Laboratory Version POC Version OTC Version STATUS Completed In Progress 6 - 9 Months* 6 Months** * Pan Probe Inc ** Overlapping 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 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)